Telenor in new Indian partnership with Lakshdeep

Norway's Telenor has signed a partnership deal with India's Lakshdeep Investments & Finance to take part in its Indian venture that may bid for a new operating license, it said on Friday.

Lakshdeep, a company controlled by Sudhir Valia, will contribute an undisclosed amount of equity into the Telewings joint venture, in which Telenor will hold a 74 percent stake, Telenor added.

Sudhir Valia is the wholetime director of Sun Pharma and Lakshdeep Investments holds 1.07% stake in the company.

Telenor says that all Uninor assets to be transferred into the new joint venture.

5 telecos express interest for spectrum bidding: DoT

Excerpts from What's Hot on CNBC-TV18 Watch the full show »

Staying with the 2G auctions, the Department of Telecom (DoT) has confirmed that five companies including Bharti Airtel  , Vodafone, Idea , Telenor and Videcon have expressed interest in bidding for GSM spectrum and two companies including Tata Tele and Videocon have expressed interest in bidding for CDMA spectrum. The ministry will draw up a list of pre qualified bidders by 28, October, 2012. 
 

DoT to request for EGoM meeting in early Nov

The Department of Telecom will seek time from Empowered Group of Ministers, headed by Finance Minister P Chidambaram, for a meeting in early November to consider the issue of reallocation of spectrum to mobile operators.
     
"We will seek time for a EGoM meeting in early November, before (spectrum) auction starts. Chairman of EGoM will decide on the date," Telecom Secretary R Chandrashekhar told reporters at the Bharat Broadband Network event.
     
He said that recommendations made by Telecom Commission will be placed before the EGoM for final decision.
     
"Final decision will be taken by EGoM on spectrum refarming (reallocation). As per present manadate, this issue is not required to go to cabinet," Chandrashekhar said.
     
Telecom Commission has recommended that existing mobile operators vacate airwaves in the 900 MHz band at the time of renewal of licences in 2014 - a move that GSM players say would cost them over Rs 66,000 crore in replacing infrastructure.
     
According to a study by Analysys Mason, spectrum refarming will call for redesigning of existing networks, mainly through the replacement of base stations commonly known as telecom towers.
     
Citing the study, GSM industry body COAI has said that such a replacement of base stations and deployment of additional sites will result in an incremental capex of Rs 54,739 crore, and incremental annual opex of Rs 11,762 crore.

Idea Cellular Q2 net profit up 2.5% at Rs 240 cr

Telecom operator Idea Cellular  's net profit grew by 2.5 percent quarter-on-quarter to Rs 240 crore in the quarter ended September 2012, which was higher than expectations of Rs 228 crore.

The fall in interest outgo helped the company improve its profitability. Interest cost declined 26.7 percent YoY and 19 percent QoQ to Rs 216 crore during the quarter.

Net sales fell a higher than expected 3.6% QoQ to Rs 5,306.8 crore during the quarter due to decline in subscriber base and lower average revenue per user (ARPU). Analysts on an average has forecast of Rs 5,430 crore.

ARPU went down by 5.1 percent QoQ to Rs 148, which was below expectations of Rs 151.5.

Earnings before interest, tax, depreciation and amortisation (EBITDA) declined marginally to Rs 1,422.5 crore from Rs 1,435.6 crore during the same period. But EBITDA Margin rose by 70 basis points to 26.8 percent versus 26.1 percent QoQ while analysts had expected it at 26.08 percent.

Average realisation per minute too improved to 41.3 paise in the second quarter of FY13 as against 41.2 paise in the previous quarter, which too was better-than-expectations of 41.1 paise.

The stock rose 0.49 percent to close at Rs 81.25 on the Bombay Stock Exchange.

Bharti Airtel world's fourth largest operator: Report

Telecom major Bharti Airtel  is the fourth largest mobile operator in the world with over 250 million connnections globally, according to analyst firm Wireless Intelligence. China Mobile continues to be at the top spot with 683.08 million connections, followed by Vodafone Group (386.88 million) and America Movil Group (251.83 million).

Bharti Airtel (250.04) and Telefonica Group (243.51) are at fourth and fifth position, respectively, Wireless Intelligence said in its 'Mobile Operator Worldwide Group Global Ranking By Connections (Q2, 2012)'.

Besides China Unicom (which is at the sixth position), the report said Bharti Airtel is the only other member of the top ten to move up the ranking, recording a 13 percent year-on-year rise in connections to overtake Telefonica.

Bharti Airtel had become the fifth largest mobile operator in the world following its acquisition of Zain Group's mobile operations across 15 African nations in June 2010, the operator said in a statement. It, however, added that Bharti's mobile revenue at USD 3.04 billion in the second quarter of FY12 is significantly lower than the other operators in the top five, "reflecting Bharti's presence in the ultra low-cost, low-margin Indian and African markets".

The other Indian telecom operators in the report are Reliance Communications  , Idea Cellular   and BSNL  at eigth, fourteenth and twentieth positions, respectively. While Reliance Communications has maintained its global ranking, Idea Cellular has moved up three places. State-run BSNL's ranking dropped by two places.

Telenor and Sistema - foreign firms with a subsidiary in India - were at the ninth and fifteenth position, respectively. Russia's Sistema Group lost four positions in the ranking, the report said.

Ericsson seeks more cost cuts as global slowdown bites

 Telecoms equipment maker Ericsson reported a 42 percent drop in third-quarter core profit and promised more cost cuts to protect itself from the global slowdown.

Telecoms gear makers are under stress from tough competition and slower spending by the operators that are their clients.

Ericsson, the world number one mobile network equipment maker, has also seen margins shrink due to more low-margin contracts in Europe that have helped it gain market share but hurt profitability.

It said these factors would continue in the short term.

"Network sales continue to be very slow and ... continue to weigh on gross margin," said Pierre Ferragu, analyst at Sanford Bernstein. "To me it is just a question of waiting for a better economic environment."

Ericsson said sales in its key networks unit fell 17 percent year-on-year, reflecting lower sales in parts of Europe, a continued decline in older standard networks in the United States and China and lower 3G sales in Russia.

It said the slowdown and political unrest had led to more cautious operator spending and added that profitability was not satisfactory, despite cost reductions over the last year.

"We will continue to proactively identify and execute additional efficiency gains and cost reductions," CEO Hans Vestberg said in a statement. He gave no details.

Ericsson shares were down 4.5 percent at 57.80 crowns in early trade against a 1 percent decline in the STOXX Europe 600 Technology Index <.SX8P>, erasing the previous day's gains. The stock has plummeted since early 2011 and hit a 3-1/2 year low of 55.9 crowns in July.

SLOWDOWN

The global slowdown has put a dent in telecoms operators' spending plans in recent quarters.

This week Sprint Nextel Corp lowered its capital spending forecast for the full year, echoing measures by rivals Verizon and AT&T .

Equipment suppliers like Ericsson and rivals Nokia Siemens Networks and Alcatel-Lucent

True Statement

Think About It

"Incredible change happens in your life when you decide to take control of what you do have power over, 

instead of craving control over what you don't."

- Steve Maraboli

Morocco: Pharmaceuticals sector increasing access to medication

Morocco's pharmaceuticals sector is negotiating a tricky balancing act at the moment, in a bid to widen access while taking into consideration worries from manufacturers and pharmacists over cost-recovery. Local production plays a significant role in satisfying domestic demand, but the market has long struggled with concerns over the prices of brand-name products, which has prompted the government to increase generic distribution and try to lower end-user prices, Global Arab Network reports according to OBG.

The pharmaceuticals sector in Morocco is the second largest on the African continent, following South Africa. It is made up of 40 industrial units, 50 distributors, and more than 11,500 pharmacies. Local production supplies 70% of domestic demand and the country exports 10% of its production, particularly to neighbouring African nations. Still, domestic consumption is rather low, with annual spending per citizen totalling about Dh400-450 (€36-40), compared to €61 in Algeria and €98 globally.

"Consumption is €24 per person per year in Morocco and in Tunisia it is €41, a difference of 70%," Patrice Fuster, the general manager of Sanofi Aventis, told OBG.

Part of the reason for the limited per capita consumption can be attributed to pricing, which has been a persistent concern for retail customers. In 2009, a parliamentary study found that prices for branded drugs were between 30% and 189% higher than in Tunisia and 20% to 70% more expensive than in France. Although price reductions have been imposed since then, cost remains a source of concern, particularly as the country is currently looking to boost access to medicine.

As a result, the government is hoping to conclude another round of price reductions by the end of December 2012, which if successful will serve to bring prices of all drugs down by 30 to 60%. Negotiations are currently being carried out between industry associations, pharmaceutical firms and the government to reach a compromise on how best to achieve these price reductions.

In this vein, the government has recently concluded agreements with the country's three main pharmaceutical organisations: the Moroccan Association of Generic Medicine Producers (Association Marocaine du Médicament Générique, AMMG), the Moroccan Association of Pharmaceutical Producers (Association Marocaine de l'Industrie Pharmaceutique, AMIP), and Health Innovation Morocco (Maroc Innovation Santé, MIS), an organisation for subsidiaries of international pharmaceutical firms, which help reduce the prices on certain medicines.

However, while price reductions may spur higher consumption, private operators in both the manufacturing and distribution segments have expressed concern over their ability to recoup costs if effective compensation measures are not put in place. Pharmacists, for example, have been particularly vocal in their worries over the potential negative impacts of price reductions. From some 2500 in the 1996, there are more than 11,500 pharmacies today in Morocco. However, the current annual average turnover per pharmacy does not exceed Dh700,000 (€63,000), down from Dh2m (€180,000) in 1996.

There may be other challenges as well. "The industry has come up with proposals for reform to change the pricing structure, but for these to have any effect, other changes are necessary, for instance in how the distribution channels are organised," Eric Reurts, the general manager of Novo Nordisk, told OBG. In the meantime, pharmacies have expressed their interest in taking part in the Medical Assistance Programme for the Economically Disadvantaged (Regime d'Assistance Médicale aux Economiquement Démunis, RAMED) through PPPs. First introduced in the Tadla-Azilal region in 2008, RAMED is expected to extend coverage to a total of 8.5m people over the next few years. The programme will help drive sales as the government looks to extend access to new medicines to participants of the RAMED programme.

Yet in spite of the challenging balance that must be struck between ensuring a profitable business environment and guaranteeing affordable access to medication – a hurdle that countries around the world face – Morocco has nonetheless emerged as one of the most attractive destinations for pharmaceutical investment over the past year.

A number of pharmaceutical firms have set up operations recently. In October 2011, Jordan-based Hikma Pharmaceuticals acquired 63.9% of Morocco's Promopharm for $111.2m and has plans to introduce more than 20 Hikma products to the market. Then, in early 2012, in a bid to acquire the rest of Promopharm, Hikma brought its share in the firm to 94.12%.

Another new entrant is India-based Ranbaxy, a major global producer of generics. Indeed, the production of generic medicine is a rapidly growing industry, with a market share of around 30%. The firm invested some Dh20m (€1.76m) to open its first unit in Casablanca, making it the third on the continent, following South Africa and Nigeria.

The short-term and medium-term outlook for the sector is impacted in part by the challenging negotiations over pricing and access, but ultimately, the fundamentals of the Moroccan market, including a sizable population, skilled labour pool and reliable infrastructure, will help ensure that domestic production, whether in brand-name or generic products, continue to grow. (OBG)

Faulty medical implants investigation: 'We’re paid by manufacturer so want deal to succeed'

The shiny office block in a business district of Seoul is not the most obvious place to find an organisation offering to authorise a medical product for use in patients throughout Europe.

But, earlier this month, in a meeting on the 14th floor of the building in South Korea, two undercover reporters from The Daily Telegraph posing as representatives from a Chinese company were discussing just such a licence.

As the air conditioning hummed in the background, the four smartly dressed Korean men began their presentation — in reality, a sales pitch about how they would effectively be able to guarantee that a metal-on-metal hip implant which should be banned could soon find its way legally into British operating theatres.

The president of the company, Dr Gong, said that the firm was the "best in the world" and the "exclusive partner" of a medical devices regulator in the Czech Republic. As part of their relationship with the regulator they did "all the results" for Asian companies that applied for the necessary CE certification.

With more than 1,000 clients, they could offer a "competitive" fee to the undercover reporters sitting before them. "We only focus on how to help our clients", said one of the employees as he flicked through the presentation.

Towards the end of the meeting, when asked by an undercover reporter why features of the European system were so attractive, Dr Gong rubbed his fingers together, saying "money".

The path to the meeting in Seoul had begun several months earlier during a joint investigation by The Daily Telegraph and the British Medical Journal into the regulation of artificial hips and other medical devices in Europe. Undercover reporters had travelled to eastern European countries, including Hungary, Slovakia and the Czech Republic to meet representatives of notified bodies — the organisations charged with offering licences — to discuss approving a potentially dangerous implant.

As this newspaper has exposed this week, several regulatory bodies were prepared to offer such licences.

But during meetings in Slovakia and the Czech Republic another loophole emerged. Two companies — 3eC in Bratislava and ITC in Zlin — said that they had Asian "representatives" who could deal with applications outside the European Union.

Under European rules, the regulatory bodies are only supposed to assess whether applications for medical devices meet the required standard. They are not supposed to offer consultancy services on how to receive the certification.

Upon arriving in the offices of ITC Cert in Seoul, the representative of the Czech notified body, the journalists were offered the services of two companies. One would assess the licence, the other would offer consultancy. The two firms appeared to share many members of staff.

Dr Gong, the president of "ITC Asia", said the firms were "separate" and "independent".

However, one of the company's employees later claimed this was not the case. "He [the president] said the company is — the companies are separate — are separately [sic]. But actually the working people are the same," said Kenneth Lee as he was driving the reporters to their hotel after the meeting.

The cost of the consultancy service was an extra $12,000 (£7,500) on top of the $17,000 certification fee. The $17,000 which was quoted was four times more than what was suggested by the company's office in the Czech Republic.

For the high fees, the ITC office in South Korea said that their clients enjoyed a high success rate. When a reporter asked the general manager, Mr Shin, about the company's success rate during a telephone call before the meeting he said that "there was no case … which [was] rejected".

Mr Lee also said that the European system was "easier" than the regulatory procedure in America because the notified bodies were paid by the manufacturer and therefore wanted an application to succeed.

The sales pitch in Seoul was similar at BS Certification Services, a "partner" firm of 3eC, which has its headquarters in Hong Kong. The undercover reporters telephoned Vidyyut Kr Bera, of BS Certification Services, in September to find out how he could help their application.

When they asked Mr Bera how many of his clients obtained CE approval for medical devices, he laughed: "It is a 100 per cent success rate as of now." He said he would charge the same as the regulator in Slovakia — thousands of euros. He said he would pay the regulator and the manufacturer did not need to pay anything to the notified body in Slovakia.

Mr Bera said that the "advantage" of using his services instead of dealing with the notified body directly was that the client "will come to know a lot of things in advance before it is done a final review" and that he was "in a position to support the client in many ways because the entire review before the file goes to notified body … is taken care of by me".

He added: "So most of the time it happens that when I approve the file and everything is completed it is very, you can say, that there will high chances that the file will pass in one attempt." However, although he would write a report for the client outlining "what is required, what is missing", he would not officially be able to act as a paid consultant.

There is now growing pressure on the British authorities to put their own checks into the system amid fears that hundreds of medical devices, which have passed through the offices in Asia, are being used on unsuspecting patients in this country.

ITC Korea said that the meeting was "simply a private talk". The spokesman defended the company, saying that "there will be also wrong and exaggerated explanation for easier understanding".

IAC HQ's response to 27 Questions to Arvind Kejriwal from Digvijay Singh

Dear Saathis,

IAC HQ is circulating point-wise  information concerning 9 of the 27 queries addressed to IAC's "saathi" Arvind by Sh. Digvijaya Singh, spokesperson AICC. These may be used to answer / clarify any questions put to our volunteers/saathis by anyone.

IAC HQ denies that Arvind has violated provisions of All India Service Rules as alleged by Sh.Digvijaya Singh. Arvind has repeatedly applied under provisions of
* The All India Services (Leave) Rules, 1955
* The All India Services (Study Leave) Regulations, 1960
* The All India Services (Joint Cadre) Rules, 1972, etc.
When his applications were malafidely not disposed of in time, Arvind followed the dictates of his conscience in the larger public interest.

Q1: Is it a fact that in your entire service of 20 years in Indian Revenue Service, you never served outside Delhi, even though the norms of the service are that all IRS officers  serve a posting only for 3 years in a place‘?
A: The facts, reasons and reasons for Arvind not being transferred out of Delhi are very well known to the Prime Minister and the Finance Minister. Everything which Arvind has "contributed" during his posting at Delhi was "shared" with his senior officers under the Finance Ministry and certainly upto the level of Finance Ministers. Posting within Delhi is not unique to Arvind. Arvind has information of at least 376 other such instances where IRS officers have been posted continuously at New Delhi for more than 10 years. Due to the severe shortage of honest and competent officers with technical skills, Arvind's tenure/postings were repeatedly extended wherever he was posted, approvals followed in due course. Just recently the Income Tax department has again written to the DoPT stressing there is a severe shortage of qualified officers extending to 21,000 vacancies. Sh.Digvijaya Singh may kindly provide, in his next letter to Arvind, all postings of Sh. Singh's good friend Sh.Pulok Chatterji, IAS during past 25 years, including his deputation to serve private NGOs closely associated with Hon'ble Chairperson NAC.

Q2: Is it a fact that even your wife, who also is an Indian Revenue Service Officer, has never served outside Delhi?
A: Same as above. Smt. Sunita Kejriwal is a honest and competent officer deputed in sensitive postings like the Serious Frauds Investigation Office under the Ministry of Corporate Affairs. Due to her qualities the SFIO had on its own repeatedly requested her tenure to be extended. Sh.Singh is making such personal allegations to ensure that honest officers are not posted to sensitive offices inquiring into the business dealings of Mr.Singh's cronies. In June 2009 Smt. Sunita Kejriwal was also appointed as the Central Public Information Officer for RTI disclosure of the Serious Frauds Investigation Office. As a consequence of discharging her designated functions in an open and transparent manner, Smt. Sunita Kejriwal was "selected" to go for advanced training in Public Administration at IIPA Delhi in 2011-12 vide DoPT's letter no. 12103/01/2011-Trg dated 27.May.2011

Q3: Is it a fact that any serving officer who goes on a study leave for two years with full pay, has to submit a full report of his study to GOI ?
A: In terms of Regulation 3 of the "The All India Services (Study Leave) Regulations, 1960" such full report is to be submitted in only in the situations covered u/r 3(1)(ii) and 3(1)(iii) therein. This does not encompass Arvind's study leaves. Sh. Singh may kindly refer to DoPT's letter AIS-III dt.9.8.1994 to broaden his knowledge.

Q4: Is it a fact that you didn't submit a full report, but only an interim report to G0I with a promise to submit a full report later, which you never did?
A: Please see answer to previous question and the concerned letter of DoPT. 

Q5: lsn’t it a fact that the Service Rules provide that an officer who goes on a study leave has to compulsorily serve GOI for 3 years ?
A: Sh. Digvijaya Singh is advised to again read the aforesaid Service Rules and DoPT's clarifications. The said Rule provides that an applicant for study leave who has previously had long term training abroad must serve the State for at least 2-3 years before the leave is sanctioned.

Q6: Is it a fact that you went on an unsanctioned leave, without permission, after serving for only one and a half year, post the study leave?
A: All the facts and circumstances concerning this are in the records of the PMO and the Finance Ministry, including the letters of recommendation sent by Hon'ble Chairperson NAC and Smt Aruna Roy member NAC etc.

Q7: Is it a fact that you were transferred to Chandigarh once, but you never joined ?

A: All the facts and circumstances concerning this are in the records of the PMO and the Finance Ministry, including the letter sent by Hon'ble Chairperson NAC. 

Q8: ls it a fact that you then sought voluntary retirement from service and even without it being approved, you absented from your office ?
A: All the facts and circumstances concerning this are in the records of the PMO and the Finance Ministry, including the letters sent by Hon'ble Chairperson NAC.

Q9: As a serving officer of IRS did you take permission of GOl to form your NGO ?

A:  Arvind was not associated with any NGO while actively serving as an IRS officer. Doing this would be in violation of the service rules applicable to him.

European standards Medical devices

Summary list of titles and references harmonised standards under Directive 93/42/EEC for Medical devices

The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.

Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.

ESO (1)	Reference and title of the harmonised standard  (and reference document)	First publication OJ	Reference of superseded standard	Date of cessation of presumption of conformity of superseded standard  Note 1
CEN	EN 285:2006+A2:2009 Sterilization - Steam sterilizers - Large sterilizers	02/12/2009	EN 285:2006+A1:2008 Note 2.1	Date expired (21/03/2010)
CEN	EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes	30/09/2005	EN 455-1:1993 Note 2.1	Date expired (30/04/2001)
CEN	EN 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation	09/08/2007	EN 455-3:1999 Note 2.1	Date expired (30/06/2007)
CEN	EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination	07/07/2010
CEN	EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices	31/07/2002	EN 556:1994 + A1:1998 Note 2.1	Date expired (30/04/2002)
	EN 556-1:2001/AC:2006	15/11/2006
CEN	EN 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices	09/08/2007
CEN	EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators	07/07/2010	EN 794-3:1998 Note 2.1	Date expired (21/03/2010)
CEN	EN 980:2008 Symbols for use in the labelling of medical devices	23/07/2008	EN 980:2003 Note 2.1	Date expired (31/05/2010)
CEN	EN 1041:2008 Information supplied by the manufacturer of medical devices	19/02/2009	EN 1041:1998 Note 2.1	Date expired (31/08/2011)
CEN	EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems	07/07/2010	EN 1060-3:1997 Note 2.1	Date expired (31/05/2010)
CEN	EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers	30/09/2005
CEN	EN 1282-2:2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)	07/07/2010	EN 1282-2:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN 1422:1997+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods	02/12/2009	EN 1422:1997 Note 2.1	Date expired (21/03/2010)
CEN	EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties	09/05/1998
CEN	EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments	07/07/2010	EN 1639:2004 Note 2.1	Date expired (30/04/2010)
CEN	EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment	07/07/2010	EN 1640:2004 Note 2.1	Date expired (30/04/2010)
CEN	EN 1641:2009 Dentistry - Medical devices for dentistry - Materials	07/07/2010	EN 1641:2004 Note 2.1	Date expired (30/04/2010)
CEN	EN 1642:2011 Dentistry - Medical devices for dentistry - Dental implants	27/04/2012	EN 1642:2009 Note 2.1	Date expired (30/04/2012)
CEN	EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings	17/05/1997
CEN	EN 1782:1998+A1:2009 Tracheal tubes and connectors	07/07/2010	EN 1782:1998 Note 2.1	Date expired (21/03/2010)
CEN	EN 1789:2007+A1:2010 Medical vehicles and their equipment - Road ambulances	18/01/2011
CEN	EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified)	07/07/2010	EN 1820:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN 1865-3:2012 (new) Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher	This is the first publication	EN 1865:1999 Note 2.1	31/12/2012
CEN	EN 1865-4:2012 (new) Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair	This is the first publication	EN 1865:1999 Note 2.1	31/10/2012
CEN	EN 1865-5:2012 (new) Patient handling equipment used in road ambulances - Part 5: Stretcher support	This is the first publication	EN 1865:1999 Note 2.1	31/12/2012
CEN	EN 1985:1998 Walking aids - General requirements and test methods	10/08/1999
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN	EN ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)	19/02/2009
CEN	EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)	27/02/2008
CEN	EN ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)	31/07/2002	EN 600:1996 Note 2.1	Date expired (31/08/2005)
	EN ISO 4074:2002/AC:2008	02/12/2009
CEN	EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)	31/07/2002	EN ISO 4135:1996 Note 2.1	Date expired (28/02/2002)
CEN	EN ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)	30/09/2005	EN 1281-1:1997 Note 2.1	Date expired (30/11/2004)
CEN	EN ISO 5356-2:2007 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)	09/11/2007	EN 1281-2:1995 Note 2.1	Date expired (29/02/2008)
CEN	EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)	23/07/2008	EN 739:1998 Note 2.1	Date expired (30/06/2010)
	EN ISO 5359:2008/A1:2011 (new)	This is the first publication	Note 3	Date expired (30/06/2012)
CEN	EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)	02/12/2009	EN ISO 5366-1:2004 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)	02/12/2009	EN ISO 5840:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)	02/12/2009	EN ISO 7197:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)	02/12/2009	EN ISO 7376:2009 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 7396-1:2007 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)	09/08/2007	EN 737-3:1998 Note 2.1	Date expired (30/04/2009)
	EN ISO 7396-1:2007/A1:2010	07/07/2010	Note 3	Date expired (31/07/2010)
	EN ISO 7396-1:2007/A2:2010	07/07/2010	Note 3	Date expired (31/08/2010)
CEN	EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)	09/08/2007	EN 737-2:1998 Note 2.1	Date expired (30/04/2009)
CEN	EN ISO 7886-3:2009 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)	07/07/2010	EN ISO 7886-3:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 7886-4:2009 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)	07/07/2010	EN ISO 7886-4:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)	02/12/2009	EN ISO 8185:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 8359:2009 Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)	02/12/2009	EN ISO 8359:1996 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 8835-2:2009 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)	02/12/2009	EN ISO 8835-2:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 8835-3:2009 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)	02/12/2009	EN ISO 8835-3:2007 Note 2.1	Date expired (21/03/2010)
	EN ISO 8835-3:2009/A1:2010	13/05/2011	Note 3	Date expired (30/04/2011)
CEN	EN ISO 8835-4:2009 Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)	02/12/2009	EN ISO 8835-4:2004 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 8835-5:2009 Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)	02/12/2009	EN ISO 8835-5:2004 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)	19/02/2009	EN 737-1:1998 Note 2.1	Date expired (31/07/2010)
CEN	EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)	19/02/2009	EN 737-4:1998 Note 2.1	Date expired (31/07/2010)
CEN	EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)	02/12/2009	EN ISO 9360-1:2000 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 9360-2:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)	02/12/2009	EN ISO 9360-2:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 9713:2009 Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)	02/12/2009	EN ISO 9713:2004 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10079-1:2009 Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)	02/12/2009	EN ISO 10079-1:1999 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10079-2:2009 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)	02/12/2009	EN ISO 10079-2:1999 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10079-3:2009 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)	02/12/2009	EN ISO 10079-3:1999 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10328:2006 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)	09/08/2007
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN	EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)	02/06/2006	EN 738-1:1997 Note 2.1	Date expired (31/10/2008)
CEN	EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)	07/06/2009	EN 738-2:1998 Note 2.1	Date expired (31/10/2008)
CEN	EN ISO 10524-3:2006 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)	07/09/2006	EN 738-3:1998 Note 2.1	Date expired (31/10/2008)
CEN	EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)	23/07/2008	EN 738-4:1998 Note 2.1	Date expired (30/06/2010)
CEN	EN ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)	09/08/2007	EN ISO 10535:1998 Note 2.1	Date expired (30/06/2007)
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN	EN ISO 10555-1:2009 Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)	02/12/2009	EN ISO 10555-1:1996 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)	02/12/2009	EN ISO 10651-2:2004 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)	02/12/2009	EN ISO 10651-4:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10651-6:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)	02/12/2009	EN ISO 10651-6:2004 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)	02/12/2009	EN ISO 10993-1:2009 Note 2.1	Date expired (21/03/2010)
	EN ISO 10993-1:2009/AC:2010	18/01/2011
CEN	EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)	02/12/2009	EN ISO 10993-3:2003 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)	02/12/2009	EN ISO 10993-4:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)	02/12/2009	EN ISO 10993-5:1999 Note 2.1	Date expired (31/12/2009)
CEN	EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)	02/12/2009	EN ISO 10993-6:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)	19/02/2009
	EN ISO 10993-7:2008/AC:2009	07/07/2010
CEN	EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)	02/12/2009	EN ISO 10993-9:2009 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)	02/12/2009	EN ISO 10993-11:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)	02/12/2009	EN ISO 10993-12:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)	18/01/2011	EN ISO 10993-13:2009 Note 2.1	Date expired (31/12/2010)
CEN	EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)	02/12/2009	EN ISO 10993-14:2001 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)	02/12/2009	EN ISO 10993-15:2000 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)	07/07/2010	EN ISO 10993-16:2009 Note 2.1	Date expired (31/08/2010)
CEN	EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)	02/12/2009	EN ISO 10993-17:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)	02/12/2009	EN ISO 10993-18:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)	09/08/2007	EN 550:1994 Note 2.1	Date expired (31/05/2010)
CEN	EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)	07/09/2006	EN 552:1994 Note 2.1	Date expired (30/04/2009)
CEN	EN ISO 11137-2:2012 (new) Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)	This is the first publication	EN ISO 11137-2:2007 Note 2.1	30/09/2012
CEN	EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)	02/12/2009	EN ISO 11138-2:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)	02/12/2009	EN ISO 11138-3:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)	02/12/2009	EN ISO 11140-1:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)	02/12/2009	EN ISO 11140-3:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11197:2009 Medical supply units (ISO 11197:2004)	02/12/2009	EN ISO 11197:2004 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)	02/12/2009	EN ISO 11607-1:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)	07/09/2006
CEN	EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)	07/09/2006	EN 1174-2:1996 EN 1174-1:1996 EN 1174-3:1996 Note 2.1	Date expired (31/10/2006)
	EN ISO 11737-1:2006/AC:2009	02/12/2009
CEN	EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)	07/07/2010
CEN	EN ISO 11810-1:2009 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)	02/12/2009
CEN	EN ISO 11810-2:2009 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)	02/12/2009	EN ISO 11810-2:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11979-8:2009 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)	02/12/2009	EN ISO 11979-8:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN 12006-2:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits	02/12/2009	EN 12006-2:1998 Note 2.1	Date expired (21/03/2010)
CEN	EN 12183:2009 Manual wheelchairs - Requirements and test methods	07/07/2010
CEN	EN 12184:2009 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods	07/07/2010
CEN	EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators	07/07/2010	EN 12342:1998 Note 2.1	Date expired (21/03/2010)
CEN	EN 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device	02/12/2009	EN 12470-1:2000 Note 2.1	Date expired (21/03/2010)
CEN	EN 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers	02/12/2009	EN 12470-2:2000 Note 2.1	Date expired (21/03/2010)
CEN	EN 12470-3:2000+A1:2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device	02/12/2009	EN 12470-3:2000 Note 2.1	Date expired (21/03/2010)
CEN	EN 12470-4:2000+A1:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement	02/12/2009	EN 12470-4:2000 Note 2.1	Date expired (21/03/2010)
CEN	EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)	07/11/2003
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN	EN 13060:2004+A2:2010 Small steam sterilizers	07/07/2010	EN 13060:2004+A1:2009 Note 2.1	Date expired (30/09/2010)
CEN	EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)	19/08/2011	EN 13824:2004 Note 2.1	Date expired (31/12/2011)
CEN	EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)	19/08/2011	EN 13824:2004 Note 2.1	Date expired (31/12/2011)
CEN	EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)	19/08/2011	EN 13824:2004 Note 2.1	Date expired (31/12/2011)
CEN	EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)	19/08/2011	EN 13824:2004 Note 2.1	Date expired (31/12/2011)
CEN	EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)	19/08/2011	EN 13824:2004 Note 2.1	Date expired (31/12/2011)
CEN	EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)	19/08/2011	EN 13824:2004 Note 2.1	Date expired (31/12/2011)
CEN	EN ISO 13485:2012 (new) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)	This is the first publication	EN ISO 13485:2003 Note 2.1	The date of this publication ()
	EN ISO 13485:2012/AC:2012 (new)	This is the first publication
CEN	EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components	07/07/2010	EN 13544-1:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors	07/07/2010	EN 13544-2:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN 13544-3:2001+A1:2009 Respiratory therapy equipment - Part 3: Air entrainment devices	07/07/2010	EN 13544-3:2001 Note 2.1	Date expired (21/03/2010)
CEN	EN 13624:2003 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)	30/09/2005
CEN	EN 13718-1:2008 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances	19/02/2009	EN 13718-1:2002 Note 2.1	Date expired (28/02/2009)
CEN	EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency	27/03/2003
	EN 13726-1:2002/AC:2003	02/12/2009
CEN	EN 13726-2:2002 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings	27/03/2003
CEN	EN 13727:2012 (new) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)	This is the first publication	EN 13727:2003 Note 2.1	30/11/2012
CEN	EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies	02/12/2009	EN 13867:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions	19/08/2011	EN 13976-1:2003 Note 2.1	Date expired (30/11/2011)
CEN	EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements	19/08/2011	EN 13976-2:2003 Note 2.1	Date expired (30/11/2011)
CEN	EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze	30/09/2005
CEN	EN 14139:2010 Ophthalmic optics - Specifications for ready-to-wear spectacles	18/01/2011
CEN	EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)	27/04/2012	EN ISO 14155:2011 Note 2.1	Date expired (30/04/2012)
CEN	EN 14180:2003+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing	07/07/2010	EN 14180:2003+A1:2009 Note 2.1	Date expired (21/03/2010)
CEN	EN 14348:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)	30/09/2005
CEN	EN ISO 14408:2009 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)	02/12/2009	EN ISO 14408:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN 14561:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)	15/11/2006
CEN	EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)	15/11/2006
CEN	EN 14563:2008 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)	19/02/2009
CEN	EN ISO 14602:2011 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)	27/04/2012	EN ISO 14602:2010 Note 2.1	Date expired (30/04/2012)
CEN	EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)	02/12/2009	EN ISO 14607:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 14630:2009 Non-active surgical implants - General requirements (ISO 14630:2008)	02/12/2009	EN ISO 14630:2008 Note 2.1	Date expired (21/03/2010)
CEN	EN 14683:2005 Surgical masks - Requirements and test methods	02/06/2006
CEN	EN ISO 14889:2009 Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)	02/12/2009	EN ISO 14889:2003 Note 2.1	Date expired (21/03/2010)
CEN	EN 14931:2006 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing	15/11/2006
CEN	EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)	07/07/2010	EN ISO 14937:2000 Note 2.1	Date expired (30/04/2010)
CEN	EN ISO 14971:2012 (new) Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)	This is the first publication	EN ISO 14971:2009 Note 2.1	The date of this publication ()
CEN	EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)	27/04/2012	EN ISO 15001:2010 Note 2.1	Date expired (30/04/2012)
CEN	EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)	19/02/2009	EN 13220:1998 Note 2.1	Date expired (31/07/2010)
CEN	EN ISO 15004-1:2009 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)	02/12/2009	EN ISO 15004-1:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 15747:2011 Plastic containers for intravenous injections (ISO 15747:2010)	27/04/2012	EN ISO 15747:2010 Note 2.1	Date expired (30/04/2012)
CEN	EN ISO 15798:2010 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)	07/07/2010
CEN	EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)	02/12/2009	EN ISO 15883-1:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)	02/12/2009	EN ISO 15883-2:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 15883-3:2009 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)	02/12/2009	EN ISO 15883-3:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)	02/12/2009	EN ISO 15883-4:2008 Note 2.1	Date expired (21/03/2010)
CEN	EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates	13/05/2011
CEN	EN ISO 16061:2009 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)	07/07/2010	EN ISO 16061:2008 Note 2.1	Date expired (28/02/2010)
CEN	EN ISO 16201:2006 Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)	19/02/2009
CEN	EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)	02/12/2009	EN ISO 17510-1:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 17510-2:2009 Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)	02/12/2009	EN ISO 17510-2:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)	30/09/2005
CEN	EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)	15/11/2006	EN 554:1994 Note 2.1	Date expired (31/08/2009)
CEN	EN ISO 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)	02/12/2009	EN ISO 18777:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)	02/12/2009	EN ISO 18778:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)	30/09/2005
CEN	EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005)	07/09/2006	EN 12218:1998 Note 2.1	Date expired (30/06/2008)
CEN	EN 20594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)	18/11/1995
	EN 20594-1:1993/A1:1997	10/08/1999	Note 3	Date expired (31/05/1998)
	EN 20594-1:1993/AC:1996	02/12/2009
CEN	EN ISO 21171:2006 Medical gloves - Determination of removable surface powder (ISO 21171:2006)	07/09/2006
CEN	EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)	02/12/2009	EN ISO 21534:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)	02/12/2009	EN ISO 21535:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)	02/12/2009	EN ISO 21536:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 21649:2009 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)	07/07/2010	EN ISO 21649:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 21969:2009 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)	07/07/2010	EN ISO 21969:2006 Note 2.1	Date expired (31/05/2010)
CEN	EN ISO 21987:2009 Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)	07/07/2010
CEN	EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)	27/02/2008	EN 12442-1:2000 Note 2.1	Date expired (30/06/2008)
CEN	EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)	27/02/2008	EN 12442-2:2000 Note 2.1	Date expired (30/06/2008)
CEN	EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)	27/02/2008	EN 12442-3:2000 Note 2.1	Date expired (30/06/2008)
CEN	EN ISO 22523:2006 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)	09/08/2007	EN 12523:1999 Note 2.1	Date expired (30/04/2007)
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN	EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)	15/11/2006
CEN	EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)	30/09/2005
CEN	EN ISO 22675:2006 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)	09/08/2007
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN	EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)	19/02/2009	EN 13328-1:2001 Note 2.1	Date expired (30/09/2008)
CEN	EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)	02/12/2009	EN ISO 23328-2:2008 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 23747:2009 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)	02/12/2009	EN ISO 23747:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 25539-1:2009 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)	02/12/2009	EN ISO 25539-1:2008 EN 12006-3:1998+A1:2009 Note 2.1	Date expired (21/03/2010)
	EN ISO 25539-1:2009/AC:2011 (new)	This is the first publication
CEN	EN ISO 25539-2:2009 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)	02/12/2009	EN ISO 25539-2:2008 EN 12006-3:1998+A1:2009 Note 2.1	Date expired (21/03/2010)
	EN ISO 25539-2:2009/AC:2011 (new)	This is the first publication
CEN	EN ISO 26782:2009 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)	07/07/2010
	EN ISO 26782:2009/AC:2009	07/07/2010
CEN	EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)	18/11/1995
	EN 27740:1992/A1:1997	10/08/1999	Note 3	Date expired (31/05/1998)
	EN 27740:1992/AC:1996	02/12/2009
CEN	EN ISO 81060-1:2012 (new) Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)	This is the first publication	EN 1060-2:1995+A1:2009 EN 1060-1:1995+A2:2009 Note 2.1	31/05/2015
Cenelec	EN 60118-13:2005 Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC) IEC 60118-13:2004	19/01/2006	EN 60118-13:1997 Note 2.1	Date expired (01/02/2008)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies IEC 60522:1999	14/11/2001
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60580:2000 Medical electrical equipment - Dose area product meters IEC 60580:2000	13/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1:2006 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005	27/11/2008	EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996 + EN 60601-1-1:2001 + EN 60601-1-4:1996 + A1:1999 Note 2.1	Date expired (01/06/2012)
	EN 60601-1:2006/AC:2010	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-2:2007 (Modified)	27/11/2008	EN 60601-1-2:2001 + A1:2006 Note 2.1	Date expired (01/06/2012)
	EN 60601-1-2:2007/AC:2010	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-3:2008 Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-1-3:2008	27/11/2008	EN 60601-1-3:1994 Note 2.1	Date expired (01/06/2012)
	EN 60601-1-3:2008/AC:2010	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-6:2007 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability IEC 60601-1-6:2006	27/11/2008	EN 60601-1-6:2004 Note 2.1	Date expired (01/06/2012)
	EN 60601-1-6:2007/AC:2010	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-6:2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-6:2010	18/01/2011	EN 60601-1-6:2007 Note 2.1	01/04/2013
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-8:2007 Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-8:2006	27/11/2008	EN 60601-1-8:2004 + A1:2006 Note 2.1	Date expired (01/06/2012)
	EN 60601-1-8:2007/AC:2010	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-10:2008 Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers IEC 60601-1-10:2007	27/11/2008
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-11:2010	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-1:1998 Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV IEC 60601-2-1:1998	14/11/2001
	EN 60601-2-1:1998/A1:2002 IEC 60601-2-1:1998/A1:2002	13/12/2002	Note 3	Date expired (01/06/2005)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-2:2009 Medical electrical equipment -- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC 60601-2-2:2009	07/07/2010	EN 60601-2-2:2007 Note 2.1	Date expired (01/04/2012)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-3:1993 Medical electrical equipment -- Part 2: Particular requirements for the safety of short-wave therapy equipment IEC 60601-2-3:1991	18/11/1995
	EN 60601-2-3:1993/A1:1998 IEC 60601-2-3:1991/A1:1998	18/11/1995	Note 3	Date expired (01/07/2001)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-4:2003 Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators IEC 60601-2-4:2002	15/10/2003
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-5:2000 Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment IEC 60601-2-5:2000	13/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-7:1998 Medical electrical equipment -- Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators IEC 60601-2-7:1998	09/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-8:1997 Medical electrical equipment -- Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV IEC 60601-2-8:1987	14/11/2001
	EN 60601-2-8:1997/A1:1997 IEC 60601-2-8:1987/A1:1997	14/11/2001	Note 3	Date expired (01/07/1998)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-10:2000 Medical electrical equipment -- Part 2-10: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-2-10:1987	13/12/2002
	EN 60601-2-10:2000/A1:2001 IEC 60601-2-10:1987/A1:2001	13/12/2002	Note 3	Date expired (01/11/2004)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-11:1997 Medical electrical equipment -- Part 2-11: Particular requirements for the safety of gamma beam therapy equipment IEC 60601-2-11:1997	09/10/1999
	EN 60601-2-11:1997/A1:2004 IEC 60601-2-11:1997/A1:2004	09/10/1999	Note 3	Date expired (01/09/2007)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-12:2006 Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators IEC 60601-2-12:2001	22/12/2007
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-13:2006 Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems IEC 60601-2-13:2003	22/12/2007
	EN 60601-2-13:2006/A1:2007 IEC 60601-2-13:2003/A1:2006	22/12/2007	Note 3	Date expired (01/03/2010)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-16:1998 Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-16:1998	09/10/1999
	EN 60601-2-16:1998/AC:1999	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-17:2004 Medical electrical equipment -- Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment IEC 60601-2-17:2004	08/11/2005	EN 60601-2-17:1996 + A1:1996 Note 2.1	Date expired (01/03/2007)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-18:1996 Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment IEC 60601-2-18:1996	09/10/1999
	EN 60601-2-18:1996/A1:2000 IEC 60601-2-18:1996/A1:2000	09/10/1999	Note 3	Date expired (01/08/2003)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-19:2009 Medical electrical equipment -- Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators IEC 60601-2-19:2009	07/07/2010	EN 60601-2-19:1996 + A1:1996	Date expired (01/04/2012)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-20:1996 Medical electrical equipment -- Part 2: Particular requirements for the safety of transport incubators IEC 60601-2-20:1990 + A1:1996	09/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-20:2009 Medical electrical equipment -- Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators IEC 60601-2-20:2009	18/01/2011	EN 60601-2-20:1996 Note 2.1	01/09/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-21:2009 Medical electrical equipment -- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers IEC 60601-2-21:2009	07/07/2010	EN 60601-2-21:1994 + A1:1996	Date expired (01/04/2012)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-22:1996 Medical electrical equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60601-2-22:1995	17/05/1997
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-23:2000 Medical electrical equipment -- Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment IEC 60601-2-23:1999	14/11/2001	EN 60601-2-23:1997 Note 2.1	Date expired (01/01/2003)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-24:1998 Medical electrical equipment -- Part 2-24: Particular requirements for the safety of infusion pumps and controllers IEC 60601-2-24:1998	09/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-25:1995 Medical electrical equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-25:1993	17/05/1997
	EN 60601-2-25:1995/A1:1999 IEC 60601-2-25:1993/A1:1999	13/12/2002	Note 3	Date expired (01/05/2002)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-26:2003 Medical electrical equipment -- Part 2-26: Particular requirements for the safety of electroencephalographs IEC 60601-2-26:2002	08/11/2005	EN 60601-2-26:1994 Note 2.1	Date expired (01/03/2006)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-27:2006 Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment IEC 60601-2-27:2005	26/07/2006	EN 60601-2-27:1994 Note 2.1	Date expired (01/11/2008)
	EN 60601-2-27:2006/AC:2006	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-28:1993 Medical electrical equipment -- Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis IEC 60601-2-28:1993	18/11/1995
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-28:2010 Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis IEC 60601-2-28:2010	18/01/2011	EN 60601-2-28:1993 Note 2.1	01/04/2013
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-29:2008 Medical electrical equipment -- Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators IEC 60601-2-29:2008	15/07/2009	EN 60601-2-29:1999 Note 2.1	Date expired (01/11/2011)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-30:2000 Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-30:1999	14/11/2001	EN 60601-2-30:1995 Note 2.1	Date expired (01/02/2003)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-32:1994 Medical electrical equipment -- Part 2: Particular requirements for the safety of associated equipment of X-ray equipment IEC 60601-2-32:1994	18/11/1995
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-33:2002 Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis IEC 60601-2-33:2002	15/10/2003	EN 60601-2-33:1995 + A11:1997 Note 2.1	Date expired (01/07/2005)
	EN 60601-2-33:2002/A1:2005 IEC 60601-2-33:2002/A1:2005	27/07/2006	Note 3	Date expired (01/11/2008)
	EN 60601-2-33:2002/A2:2008 IEC 60601-2-33:2002/A2:2007	27/11/2008	Note 3	Date expired (01/02/2011)
	EN 60601-2-33:2002/A2:2008/AC:2008 (new)	This is the first publication
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-34:2000 Medical electrical equipment -- Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment IEC 60601-2-34:2000	15/10/2003	EN 60601-2-34:1995 Note 2.1	Date expired (01/11/2003)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-35:1996 Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use IEC 60601-2-35:1996	09/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-36:1997 Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy IEC 60601-2-36:1997	09/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-37:2008 Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment IEC 60601-2-37:2007	27/11/2008	EN 60601-2-37:2001 + A1:2005 + A2:2005 Note 2.1	Date expired (01/10/2010)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-38:1996 Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds IEC 60601-2-38:1996	09/10/1999
	EN 60601-2-38:1996/A1:2000 IEC 60601-2-38:1996/A1:1999	14/11/2001	Note 3	Date expired (01/01/2003)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-39:2008 Medical electrical equipment -- Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment IEC 60601-2-39:2007	27/11/2008	EN 60601-2-39:1999 Note 2.1	Date expired (01/03/2011)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-40:1998 Medical electrical equipment -- Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment IEC 60601-2-40:1998	09/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-41:2000 Medical electrical equipment -- Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis IEC 60601-2-41:2000	14/11/2001
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-41:2009 Medical electrical equipment -- Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis IEC 60601-2-41:2009	18/01/2011	EN 60601-2-41:2000 Note 2.1	01/11/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-43:2000 Medical electrical equipment -- Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures IEC 60601-2-43:2000	13/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-43:2010 Medical electrical equipment -- Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures IEC 60601-2-43:2010	18/01/2011	EN 60601-2-43:2000 + EN 60601-2-54:2009	01/06/2013
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-44:2009 Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography IEC 60601-2-44:2009	07/07/2010	EN 60601-2-44:2001 + A1:2003 Note 2.1	Date expired (01/05/2012)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-45:2001 Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices IEC 60601-2-45:2001	14/11/2001	EN 60601-2-45:1998 Note 2.1	Date expired (01/07/2004)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-46:1998 Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tables IEC 60601-2-46:1998	14/11/2001
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-47:2001 Medical electrical equipment -- Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems IEC 60601-2-47:2001	13/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-49:2001 Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment IEC 60601-2-49:2001	13/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-50:2009 Medical electrical equipment -- Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment IEC 60601-2-50:2009	07/07/2010	EN 60601-2-50:2002 Note 2.1	Date expired (01/05/2012)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-51:2003 Medical electrical equipment -- Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs IEC 60601-2-51:2003	24/06/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-52:2010 Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds IEC 60601-2-52:2009	13/05/2011	EN 60601-2-38:1996 and its amendment + EN 1970:2000 Note 2.1	Date expired (01/06/2012)
	EN 60601-2-52:2010/AC:2011 (new)	This is the first publication
(*): Date of cessation of presumption of conformity of superseded standard is corrected. This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-2-54:2009 Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 60601-2-54:2009	18/01/2011	EN 60601-2-7:1998 + EN 60601-2-28:1993 + EN 60601-2-32:1994 Note 2.1	Date expired (01/08/2012)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60627:2001 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids IEC 60627:2001	13/12/2002
	EN 60627:2001/AC:2002	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60645-1:2001 Electroacoustics - Audiological equipment -- Part 1: Pure-tone audiometers IEC 60645-1:2001	13/12/2002	EN 60645-1:1994 Note 2.1	Date expired (01/10/2004)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60645-2:1997 Audiometers -- Part 2: Equipment for speech audiometry IEC 60645-2:1993	17/05/1997
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60645-3:2007 Electroacoustics - Audiometric equipment -- Part 3: Test signals of short duration IEC 60645-3:2007	27/11/2008	EN 60645-3:1995 Note 2.1	Date expired (01/06/2010)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60645-4:1995 Audiometers -- Part 4: Equipment for extended high-frequency audiometry IEC 60645-4:1994	23/08/1996
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 61217:1996 Radiotherapy equipment - Coordinates, movements and scales IEC 61217:1996	14/11/2001
	EN 61217:1996/A1:2001 IEC 61217:1996/A1:2000	14/11/2001	Note 3	Date expired (01/12/2003)
	EN 61217:1996/A2:2008 IEC 61217:1996/A2:2007	27/11/2008	Note 3	Date expired (01/02/2011)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 61217:2012 (new) Radiotherapy equipment - Coordinates, movements and scales IEC 61217:2011	This is the first publication	EN 61217:1996 and its amendments Note 2.1	11/01/2015
Cenelec	EN 61676:2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC 61676:2002	15/10/2003
	EN 61676:2002/A1:2009 IEC 61676:2002/A1:2008	07/07/2010	Note 3	Date expired (01/03/2012)
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62083:2001 Medical electrical equipment -- Requirements for the safety of radiotherapy treatment planning systems IEC 62083:2000	13/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems IEC 62083:2009	18/01/2011	EN 62083:2001 Note 2.1	01/11/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62220-1:2004 Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1: Determination of the detective quantum efficiency IEC 62220-1:2003	24/06/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62220-1-2:2007 Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography IEC 62220-1-2:2007	27/11/2008
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62220-1-3:2008 Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging IEC 62220-1-3:2008	15/07/2009
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62304:2006 Medical device software - Software life-cycle processes IEC 62304:2006	27/11/2008
	EN 62304:2006/AC:2008	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62366:2008 Medical devices - Application of usability engineering to medical devices IEC 62366:2007	27/11/2008
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 80601-2-35:2009 Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use IEC 80601-2-35:2009	18/01/2011	EN 60601-2-35:1996 Note 2.1	01/11/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 80601-2-58:2009 Medical electrical equipment -- Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery IEC 80601-2-58:2008	07/07/2010
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 80601-2-59:2009 Medical electrical equipment -- Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening IEC 80601-2-59:2008	18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.