Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)  Text with EEA relevance
Date: 2014-05-16
Institutions: European Commission
Subjects: Cenelec, European Committee for Standardisation, European standard, approximation of laws, marketing, medical device








C_2014149EN.01000301.xml










16.5.2014   


EN


Official Journal of the European Union


C 149/3





Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
2014/C 149/02









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Reference of superseded standard


Date of cessation of presumption of conformity of superseded standard Note 1




(1)


(2)


(3)


(4)


(5)




CEN


EN 285:2006+A2:2009
Sterilization — Steam sterilizers — Large sterilizers


2.12.2009


EN 285:2006+A1:2008
Note 2.1


Date expired
(21.3.2010)




CEN


EN 455-1:2000
Medical gloves for single use — Part 1: Requirements and testing for freedom from holes


30.9.2005


EN 455-1:1993
Note 2.1


Date expired
(30.4.2001)




CEN


EN 455-2:2009+A2:2013
Medical gloves for single use — Part 2: Requirements and testing for physical properties


This is the first publication


EN 455-2:2009+A1:2011
Note 2.1


31.10.2014




CEN


EN 455-3:2006
Medical gloves for single use — Part 3: Requirements and testing for biological evaluation


9.8.2007


EN 455-3:1999
Note 2.1


Date expired
(30.6.2007)




CEN


EN 455-4:2009
Medical gloves for single use — Part 4: Requirements and testing for shelf life determination


7.7.2010


 


 




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


31.7.2002


EN 556:1994 + A1:1998
Note 2.1


Date expired
(30.4.2002)




 


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


9.8.2007


 


 




CEN


EN 794-3:1998+A2:2009
Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators


7.7.2010


EN 794-3:1998
Note 2.1


Date expired
(21.3.2010)




CEN


EN 980:2008
Symbols for use in the labelling of medical devices


23.7.2008


EN 980:2003
Note 2.1


Date expired
(31.5.2010)




CEN


EN 1041:2008
Information supplied by the manufacturer of medical devices


19.2.2009


EN 1041:1998
Note 2.1


Date expired
(31.8.2011)




CEN


EN 1060-3:1997+A2:2009
Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems


7.7.2010


EN 1060-3:1997
Note 2.1


Date expired
(31.5.2010)




CEN


EN 1060-4:2004
Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers


30.9.2005


 


 




CEN


EN ISO 1135-4:2011
Transfusion equipment for medical use — Part 4: Transfusion sets for single use (ISO 1135-4:2010)


27.4.2012


EN ISO 1135-4:2010
Note 2.1


Date expired
(30.4.2012)




CEN


EN 1282-2:2005+A1:2009
Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified)


7.7.2010


EN 1282-2:2005
Note 2.1


Date expired
(21.3.2010)




CEN


EN 1422:1997+A1:2009
Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods


2.12.2009


EN 1422:1997
Note 2.1


Date expired
(21.3.2010)




CEN


EN 1618:1997
Catheters other than intravascular catheters — Test methods for common properties


9.5.1998


 


 




CEN


EN 1639:2009
Dentistry — Medical devices for dentistry — Instruments


7.7.2010


EN 1639:2004
Note 2.1


Date expired
(30.4.2010)




CEN


EN 1640:2009
Dentistry — Medical devices for dentistry — Equipment


7.7.2010


EN 1640:2004
Note 2.1


Date expired
(30.4.2010)




CEN


EN 1641:2009
Dentistry — Medical devices for dentistry — Materials


7.7.2010


EN 1641:2004
Note 2.1


Date expired
(30.4.2010)




CEN


EN 1642:2011
Dentistry — Medical devices for dentistry — Dental implants


27.4.2012


EN 1642:2009
Note 2.1


Date expired
(30.4.2012)




CEN


EN 1707:1996
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings


17.5.1997


 


 




CEN


EN 1782:1998+A1:2009
Tracheal tubes and connectors


7.7.2010


EN 1782:1998
Note 2.1


Date expired
(21.3.2010)




CEN


EN 1789:2007+A1:2010
Medical vehicles and their equipment — Road ambulances


18.1.2011


 


 




CEN


EN 1820:2005+A1:2009
Anaesthetic reservoir bags (ISO 5362:2000, modified)


7.7.2010


EN 1820:2005
Note 2.1


Date expired
(21.3.2010)




CEN


EN 1865-3:2012
Patient handling equipment used in road ambulances — Part 3: Heavy duty stretcher


30.8.2012


EN 1865:1999
Note 2.1


Date expired
(31.12.2012)




CEN


EN 1865-4:2012
Patient handling equipment used in road ambulances — Part 4: Foldable patient transfer chair


30.8.2012


EN 1865:1999
Note 2.1


Date expired
(31.10.2012)




CEN


EN 1865-5:2012
Patient handling equipment used in road ambulances — Part 5: Stretcher support


30.8.2012


EN 1865:1999
Note 2.1


Date expired
(31.12.2012)




CEN


EN 1985:1998
Walking aids — General requirements and test methods


10.8.1999


 


 




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)


19.2.2009


 


 




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)


27.2.2008


 


 




CEN


EN ISO 4074:2002
Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002)


31.7.2002


EN 600:1996
Note 2.1


Date expired
(31.8.2005)




 


EN ISO 4074:2002/AC:2008


2.12.2009


 


 




CEN


EN ISO 4135:2001
Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001)


31.7.2002


EN ISO 4135:1996
Note 2.1


Date expired
(28.2.2002)




CEN


EN ISO 5356-1:2004
Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004)


30.9.2005


EN 1281-1:1997
Note 2.1


Date expired
(30.11.2004)




CEN


EN ISO 5359:2008
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)


23.7.2008


EN 739:1998
Note 2.1


Date expired
(30.6.2010)




 


EN ISO 5359:2008/A1:2011


30.8.2012


Note 3


Date expired
(30.6.2012)




CEN


EN ISO 5360:2009
Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006)


2.12.2009


EN ISO 5360:2007
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 5366-1:2004
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 5840:2009
Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005)


2.12.2009


EN ISO 5840:2005
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 7197:2009
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)


2.12.2009


EN ISO 7197:2006
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 7376:2009
Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2009)


2.12.2009


EN ISO 7376:2009
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 7396-1:2007
Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)


9.8.2007


EN 737-3:1998
Note 2.1


Date expired
(30.4.2009)




 


EN ISO 7396-1:2007/A1:2010


7.7.2010


Note 3


Date expired
(31.7.2010)




 


EN ISO 7396-1:2007/A2:2010


7.7.2010


Note 3


Date expired
(31.8.2010)




CEN


EN ISO 7396-2:2007
Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)


9.8.2007


EN 737-2:1998
Note 2.1


Date expired
(30.4.2009)




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)


7.7.2010


EN ISO 7886-3:2005
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 7886-4:2009
Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)


7.7.2010


EN ISO 7886-4:2006
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 8185:2009
Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007)


2.12.2009


EN ISO 8185:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 8359:2009
Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996)


2.12.2009


EN ISO 8359:1996
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 8835-2:2009
Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)


2.12.2009


EN ISO 8835-2:2007
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 8835-3:2007
Note 2.1


Date expired
(21.3.2010)




 


EN ISO 8835-3:2009/A1:2010


13.5.2011


Note 3


Date expired
(30.4.2011)




CEN


EN ISO 8835-4:2009
Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)


2.12.2009


EN ISO 8835-4:2004
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 8835-5:2009
Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators (ISO 8835-5:2004)


2.12.2009


EN ISO 8835-5:2004
Note 2.1


Date expired
(21.3.2010)




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)


19.2.2009


EN 737-1:1998
Note 2.1


Date expired
(31.7.2010)




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)


19.2.2009


EN 737-4:1998
Note 2.1


Date expired
(31.7.2010)




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)


2.12.2009


EN ISO 9360-1:2000
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 9360-2:2002
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 9713:2009
Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002)


2.12.2009


EN ISO 9713:2004
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10079-1:2009
Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999)


2.12.2009


EN ISO 10079-1:1999
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10079-2:2009
Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999)


2.12.2009


EN ISO 10079-2:1999
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10079-3:2009
Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)


2.12.2009


EN ISO 10079-3:1999
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10328:2006
Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods (ISO 10328:2006)


9.8.2007


 


 




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)


2.6.2006


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)


7.6.2009


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)


7.9.2006


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)


23.7.2008


EN 738-4:1998
Note 2.1


Date expired
(30.6.2010)




CEN


EN ISO 10535:2006
Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:2006)


9.8.2007


EN ISO 10535:1998
Note 2.1


Date expired
(30.6.2007)




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)


2.12.2009


EN ISO 10555-1:1996
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 10651-2:2004
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10651-4:2009
Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)


2.12.2009


EN ISO 10651-4:2002
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 10651-6:2004
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 10993-1:2009
Note 2.1


Date expired
(21.3.2010)




 


EN ISO 10993-1:2009/AC:2010


18.1.2011


 


 




CEN


EN ISO 10993-3:2009
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)


2.12.2009


EN ISO 10993-3:2003
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 10993-4:2002
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10993-5:2009
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)


2.12.2009


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)


2.12.2009


EN ISO 10993-6:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10993-7:2008
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)


19.2.2009


 


 




 


EN ISO 10993-7:2008/AC:2009


7.7.2010


 


 




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)


2.12.2009


EN ISO 10993-9:2009
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10993-11:2009
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)


2.12.2009


EN ISO 10993-11:2006
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10993-12:2012
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012)


24.1.2013


EN ISO 10993-12:2009
Note 2.1


Date expired
(31.1.2013)




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)


18.1.2011


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)


2.12.2009


EN ISO 10993-14:2001
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 10993-15:2000
Note 2.1


Date expired
(21.3.2010)




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)


7.7.2010


EN ISO 10993-16:2009
Note 2.1


Date expired
(31.8.2010)




CEN


EN ISO 10993-17:2009
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)


2.12.2009


EN ISO 10993-17:2002
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 10993-18:2009
Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)


2.12.2009


EN ISO 10993-18:2005
Note 2.1


Date expired
(21.3.2010)




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)


9.8.2007


EN 550:1994
Note 2.1


Date expired
(31.5.2010)




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)


7.9.2006


EN 552:1994
Note 2.1


Date expired
(30.4.2009)




 


EN ISO 11137-1:2006/A1:2013


This is the first publication


Note 3


30.11.2014




CEN


EN ISO 11137-2:2013
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)


This is the first publication


EN ISO 11137-2:2012
Note 2.1


30.11.2014




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)


2.12.2009


EN ISO 11138-2:2006
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 11138-3:2006
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 11140-1:2009
Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)


2.12.2009


EN ISO 11140-1:2005
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 11140-3:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 11197:2009
Medical supply units (ISO 11197:2004)


2.12.2009


EN ISO 11197:2004
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 11607-1:2006
Note 2.1


Date expired
(21.3.2010)




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)


7.9.2006


 


 




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)


7.9.2006


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


2.12.2009


 


 




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)


7.7.2010


 


 




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)


2.12.2009


 


 




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)


2.12.2009


EN ISO 11810-2:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 11979-8:2009
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006)


2.12.2009


EN ISO 11979-8:2006
Note 2.1


Date expired
(21.3.2010)




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


2.12.2009


EN 12006-2:1998
Note 2.1


Date expired
(21.3.2010)




CEN


EN 12006-3:1998+A1:2009
Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices


2.12.2009


EN 12006-3:1998
Note 2.1


Date expired
(21.3.2010)




CEN


EN 12183:2009
Manual wheelchairs — Requirements and test methods


7.7.2010


 


 




CEN


EN 12184:2009
Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods


7.7.2010


 


 




CEN


EN 12342:1998+A1:2009
Breathing tubes intended for use with anaesthetic apparatus and ventilators


7.7.2010


EN 12342:1998
Note 2.1


Date expired
(21.3.2010)




CEN


EN 12470-1:2000+A1:2009
Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device


2.12.2009


EN 12470-1:2000
Note 2.1


Date expired
(21.3.2010)




CEN


EN 12470-2:2000+A1:2009
Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers


2.12.2009


EN 12470-2:2000
Note 2.1


Date expired
(21.3.2010)




CEN


EN 12470-3:2000+A1:2009
Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device


2.12.2009


EN 12470-3:2000
Note 2.1


Date expired
(21.3.2010)




CEN


EN 12470-4:2000+A1:2009
Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement


2.12.2009


EN 12470-4:2000
Note 2.1


Date expired
(21.3.2010)




CEN


EN 12470-5:2003
Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device)


7.11.2003


 


 




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 ISO 12870:2009
Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004)


2.12.2009


EN ISO 12870:2004
Note 2.1


Date expired
(21.3.2010)




CEN


EN 13060:2004+A2:2010
Small steam sterilizers


7.7.2010


EN 13060:2004+A1:2009
Note 2.1


Date expired
(30.9.2010)




CEN


EN ISO 13408-1:2011
Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008)


19.8.2011


EN 13824:2004
Note 2.1


Date expired
(31.12.2011)




 


EN ISO 13408-1:2011/A1:2013


This is the first publication


Note 3


30.11.2014




CEN


EN ISO 13408-2:2011
Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003)


19.8.2011


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)


19.8.2011


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)


19.8.2011


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)


19.8.2011


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)


19.8.2011


EN 13824:2004
Note 2.1


Date expired
(31.12.2011)




CEN


EN ISO 13485:2012
Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)


30.8.2012


EN ISO 13485:2003
Note 2.1


Date expired
(31.8.2012)




 


EN ISO 13485:2012/AC:2012


30.8.2012


 


 




CEN


EN 13544-1:2007+A1:2009
Respiratory therapy equipment — Part 1: Nebulizing systems and their components


7.7.2010


EN 13544-1:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN 13544-2:2002+A1:2009
Respiratory therapy equipment — Part 2: Tubing and connectors


7.7.2010


EN 13544-2:2002
Note 2.1


Date expired
(21.3.2010)




CEN


EN 13544-3:2001+A1:2009
Respiratory therapy equipment — Part 3: Air entrainment devices


7.7.2010


EN 13544-3:2001
Note 2.1


Date expired
(21.3.2010)




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)


30.9.2005


 


 




CEN


EN 13718-1:2008
Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances


19.2.2009


EN 13718-1:2002
Note 2.1


Date expired
(28.2.2009)




CEN


EN 13726-1:2002
Test methods for primary wound dressings — Part 1: Aspects of absorbency


27.3.2003


 


 




 


EN 13726-1:2002/AC:2003


2.12.2009


 


 




CEN


EN 13726-2:2002
Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings


27.3.2003


 


 




CEN


EN 13727:2012
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)


30.8.2012


EN 13727:2003
Note 2.1


Date expired
(30.11.2012)




CEN


EN 13867:2002+A1:2009
Concentrates for haemodialysis and related therapies


2.12.2009


EN 13867:2002
Note 2.1


Date expired
(21.3.2010)




CEN


EN 13976-1:2011
Rescue systems — Transportation of incubators — Part 1: Interface conditions


19.8.2011


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


19.8.2011


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


30.9.2005


 


 




CEN


EN 14139:2010
Ophthalmic optics — Specifications for ready-to-wear spectacles


18.1.2011


 


 




CEN


EN ISO 14155:2011
Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011)


27.4.2012


EN ISO 14155:2011
Note 2.1


Date expired
(30.4.2012)




CEN


EN 14180:2003+A2:2009
Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing


7.7.2010


EN 14180:2003+A1:2009
Note 2.1


Date expired
(21.3.2010)




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)


30.9.2005


 


 




CEN


EN ISO 14408:2009
Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005)


2.12.2009


EN ISO 14408:2005
Note 2.1


Date expired
(21.3.2010)




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)


19.2.2009


 


 




CEN


EN ISO 14602:2011
Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:2010)


27.4.2012


EN ISO 14602:2010
Note 2.1


Date expired
(30.4.2012)




CEN


EN ISO 14607:2009
Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007)


2.12.2009


EN ISO 14607:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 14630:2009
Non-active surgical implants — General requirements (ISO 14630:2008)


2.12.2009


EN ISO 14630:2008
Note 2.1


Date expired
(21.3.2010)




CEN


EN 14683:2005
Surgical masks — Requirements and test methods


2.6.2006


 


 




CEN


EN ISO 14889:2009
Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003)


2.12.2009


EN ISO 14889:2003
Note 2.1


Date expired
(21.3.2010)




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)


7.7.2010


EN ISO 14937:2000
Note 2.1


Date expired
(30.4.2010)




CEN


EN ISO 14971:2012
Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)


30.8.2012


EN ISO 14971:2009
Note 2.1


Date expired
(30.8.2012)




CEN


EN ISO 15001:2011
Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2010)


27.4.2012


EN ISO 15001:2010
Note 2.1


Date expired
(30.4.2012)




CEN


EN ISO 15002:2008
Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)


19.2.2009


EN 13220:1998
Note 2.1


Date expired
(31.7.2010)




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)


2.12.2009


EN ISO 15004-1:2006
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 15747:2011
Plastic containers for intravenous injections (ISO 15747:2010)


27.4.2012


EN ISO 15747:2010
Note 2.1


Date expired
(30.4.2012)




CEN


EN ISO 15798:2010
Ophthalmic implants — Ophthalmic viscosurgical devices (ISO 15798:2010)


7.7.2010


 


 




CEN


EN ISO 15883-1:2009
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)


2.12.2009


EN ISO 15883-1:2006
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 15883-2:2006
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 15883-3:2006
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 15883-4:2008
Note 2.1


Date expired
(21.3.2010)




CEN


EN 15986:2011
Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates


13.5.2011


 


 




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)


7.7.2010


EN ISO 16061:2008
Note 2.1


Date expired
(28.2.2010)




CEN


EN ISO 16201:2006
Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006)


19.2.2009


 


 




CEN


EN ISO 17510-1:2009
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)


2.12.2009


EN ISO 17510-1:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 17510-2:2009
Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007)


2.12.2009


EN ISO 17510-2:2007
Note 2.1


Date expired
(21.3.2010)




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)


30.9.2005


 


 




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
(31.8.2009)




CEN


EN ISO 18777:2009
Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005)


2.12.2009


EN ISO 18777:2005
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 18778:2009
Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005)


2.12.2009


EN ISO 18778:2005
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005)


30.9.2005


 


 




CEN


EN ISO 19054:2006
Rail systems for supporting medical equipment (ISO 19054:2005)


7.9.2006


EN 12218:1998
Note 2.1


Date expired
(30.6.2008)




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


10.8.1999


Note 3


Date expired
(31.5.1998)




 


EN 20594-1:1993/AC:1996


2.12.2009


 


 




CEN


EN ISO 21534:2009
Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007)


2.12.2009


EN ISO 21534:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 21535:2009
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007)


2.12.2009


EN ISO 21535:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 21536:2009
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007)


2.12.2009


EN ISO 21536:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 21649:2009
Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006)


7.7.2010


EN ISO 21649:2006
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 21969:2009
High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)


7.7.2010


EN ISO 21969:2006
Note 2.1


Date expired
(31.5.2010)




CEN


EN ISO 21987:2009
Ophthalmic optics — Mounted spectacle lenses (ISO 21987:2009)


7.7.2010


 


 




CEN


EN ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007)


27.2.2008


EN 12442-1:2000
Note 2.1


Date expired
(30.6.2008)




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)


27.2.2008


EN 12442-2:2000
Note 2.1


Date expired
(30.6.2008)




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)


27.2.2008


EN 12442-3:2000
Note 2.1


Date expired
(30.6.2008)




CEN


EN ISO 22523:2006
External limb prostheses and external orthoses — Requirements and test methods (ISO 22523:2006)


9.8.2007


EN 12523:1999
Note 2.1


Date expired
(30.4.2007)




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 22675:2006
Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods (ISO 22675:2006)


9.8.2007


 


 




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)


19.2.2009


EN 13328-1:2001
Note 2.1


Date expired
(30.9.2008)




CEN


EN ISO 23328-2:2009
Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002)


2.12.2009


EN ISO 23328-2:2008
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 23747:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 25539-1:2009
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)


2.12.2009


EN ISO 25539-1:2008
EN 12006-3:1998+A1:2009
Note 2.1


Date expired
(21.3.2010)




 


EN ISO 25539-1:2009/AC:2011


30.8.2012


 


 




CEN


EN ISO 25539-2:2009
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents (ISO 25539-2:2008)


2.12.2009


EN ISO 25539-2:2008
EN 12006-3:1998+A1:2009
Note 2.1


Date expired
(21.3.2010)




 


EN ISO 25539-2:2009/AC:2011


30.8.2012


 


 




CEN


EN ISO 26782:2009
Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)


7.7.2010


 


 




 


EN ISO 26782:2009/AC:2009


7.7.2010


 


 




CEN


EN 27740:1992
Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)


18.11.1995


 


 




 


EN 27740:1992/A1:1997


10.8.1999


Note 3


Date expired
(31.5.1998)




 


EN 27740:1992/AC:1996


2.12.2009


 


 




CEN


EN ISO 81060-1:2012
Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)


30.8.2012


EN 1060-2:1995+A1:2009
EN 1060-1:1995+A2:2009
Note 2.1


31.5.2015




Cenelec


EN 60118-13:2005
Electroacoustics — Hearing aids — Part 13: Electromagnetic compatibility (EMC)
IEC 60118-13:2004


19.1.2006


EN 60118-13:1997
Note 2.1


Date expired
(1.2.2008)




(*): 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
and its amendments
+ EN 60601-1-1:2001
+ EN 60601-1-4:1996
and its amendment
Note 2.1


Date expired
(1.6.2012)




 


EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012


This is the first publication


Note 3


31.12.2017




 


EN 60601-1:2006/AC:2010


18.1.2011


 


 




Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.




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
(1.6.2012)




 


EN 60601-1-2:2007/AC:2010


18.1.2011


 


 




(*): 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
(1.6.2012)




 


EN 60601-1-3:2008/AC:2010


18.1.2011


 


 




(*): 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


18.1.2011


EN 60601-1-6:2007
Note 2.1


Date expired
(1.4.2013)




(*): 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
(1.6.2012)




 


EN 60601-1-8:2007/AC:2010


18.1.2011


 


 




(*): 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


18.1.2011


 


 




(*): 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
(1.6.2005)




(*): 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


7.7.2010


EN 60601-2-2:2007
Note 2.1


Date expired
(1.4.2012)




(*): 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
(1.7.2001)




(*): 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 60601-2-8:1997
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
(1.7.1998)




(*): 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
(1.11.2004)




(*): 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


9.10.1999


 


 




 


EN 60601-2-11:1997/A1:2004
IEC 60601-2-11:1997/A1:2004


9.10.1999


Note 3


Date expired
(1.9.2007)




(*): 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
(1.3.2010)




(*): 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


9.10.1999


 


 




 


EN 60601-2-16:1998/AC:1999


18.1.2011


 


 




(*): 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


8.11.2005


EN 60601-2-17:1996
+ A1:1996
Note 2.1


Date expired
(1.3.2007)




(*): 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


9.10.1999


 


 




 


EN 60601-2-18:1996/A1:2000
IEC 60601-2-18:1996/A1:2000


9.10.1999


Note 3


Date expired
(1.8.2003)




(*): 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


7.7.2010


EN 60601-2-19:1996
+ A1:1996
Note 2.1


Date expired
(1.4.2012)




(*): 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


18.1.2011


EN 60601-2-20:1996
Note 2.1


Date expired
(1.9.2012)




(*): 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


7.7.2010


EN 60601-2-21:1994
+ A1:1996
Note 2.1


Date expired
(1.4.2012)




(*): 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


17.5.1997


 


 




(*): 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
(1.1.2003)




(*): 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


9.10.1999


 


 




(*): 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


17.5.1997


 


 




 


EN 60601-2-25:1995/A1:1999
IEC 60601-2-25:1993/A1:1999


13.12.2002


Note 3


Date expired
(1.5.2002)




(*): 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


8.11.2005


EN 60601-2-26:1994
Note 2.1


Date expired
(1.3.2006)




(*): 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


26.7.2006


EN 60601-2-27:1994
Note 2.1


Date expired
(1.11.2008)




 


EN 60601-2-27:2006/AC:2006


18.1.2011


 


 




(*): 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


18.1.2011


EN 60601-2-28:1993
Note 2.1


Date expired
(1.4.2013)




(*): 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


15.7.2009


EN 60601-2-29:1999
Note 2.1


Date expired
(1.11.2011)




(*): 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
(1.11.2003)




(*): 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


9.10.1999


 


 




(*): 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
(1.10.2010)




(*): 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
(1.3.2011)




(*): 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


9.10.1999


 


 




(*): 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


18.1.2011


EN 60601-2-41:2000
Note 2.1


Date expired
(1.11.2012)




(*): 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


18.1.2011


EN 60601-2-43:2000
+ EN 60601-2-54:2009
Note 2.1


Date expired
(1.6.2013)




(*): 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
(1.7.2004)




(*): 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


7.7.2010


EN 60601-2-50:2002
Note 2.1


Date expired
(1.5.2012)




(*): 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


24.6.2004


 


 




(*): 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


13.5.2011


EN 60601-2-38:1996
+ A1:2000
+ EN 1970:2000
Note 2.1


Date expired
(1.6.2012)




 


EN 60601-2-52:2010/AC:2011


30.8.2012


 


 




(*): 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


18.1.2011


 


 




(*): 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
(1.10.2004)




(*): 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


17.5.1997


 


 




(*): 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
(1.6.2010)




(*): 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


23.8.1996


 


 




(*): 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
(1.12.2003)




 


EN 61217:1996/A2:2008
IEC 61217:1996/A2:2007


27.11.2008


Note 3


Date expired
(1.2.2011)




(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.




Cenelec


EN 61217:2012
Radiotherapy equipment — Coordinates, movements and scales
IEC 61217:2011


30.8.2012


EN 61217:1996
and its amendments
Note 2.1


11.1.2015




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


7.7.2010


Note 3


Date expired
(1.3.2012)




(*): 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


18.1.2011


EN 62083:2001
Note 2.1


Date expired
(1.11.2012)




(*): 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


24.6.2004


 


 




(*): 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


15.7.2009


 


 




(*): 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


18.1.2011


 


 




(*): 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


18.1.2011


EN 60601-2-35:1996
Note 2.1


Date expired
(1.11.2012)




(*): 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


7.7.2010


 


 




(*): 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


18.1.2011


 


 




(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.










Note 1:


Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.










Note 2.1:


The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.










Note 2.2:


The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.










Note 2.3:


The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.










Note 3:


In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.




NOTE:






—


Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012. (2)











—


Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.










—


References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation.










—


Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.










—


This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.










—


More information about harmonised standards and other European standards on the Internet at
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm






(1)  ESO: European standardisation organisation:






—


CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu)










—


CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu)










—


ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)





(2)  OJ L 316, 14.11.2012, p. 12.