Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Text with EEA relevance) (Publication of titles and references of harmonised standards under the Directive)
Date: 2009-12-02
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health








C_2009293EN.01003901.xml










2.12.2009   


EN


Official Journal of the European Union


C 293/39





Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
(Text with EEA relevance)
(Publication of titles and references of harmonised standards under the Directive)
2009/C 293/03









European Standards Organisation (1)



Reference and title of the harmonised standard
(and reference document)


First publication in the Official Journal


Reference of superseded standard


Date of cessation of presumption of conformity of superseded standard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




CEN


EN 285:2006 + A2:2009
Sterilisation — Steam sterilisers — Large sterilisers


This is the first publication


EN 285:2006 + A1:2008
EN 285:2006
Note 2.1


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 455-2:2000
Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)


31.7.2002


EN 455-2:1995
Note 2.1


Date expired
(30.4.2001)




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 556-1:2001
Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised 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
Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices


9.8.2007


 


 




CEN


EN 794-1:1997 + A2:2009
Lung ventilators — Part 1: Particular requirements for critical care ventilators


This is the first publication


EN 794-1:1997
Note 2.1


21.3.2010




CEN


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


28.6.1999


 


 




EN 794-3:1998/A1:2005


2.6.2006


Note 3


Date expired
(31.12.2005)




CEN


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


23.7.2008


EN 980:2003
Note 2.1


31.5.2010




CEN


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


19.2.2009


EN 1041:1998
Note 2.1


31.8.2011




CEN


EN 1060-1:1995
Non-invasive sphygmomanometers — Part 1: General requirements


23.8.1996


 


 




EN 1060-1:1995/A1:2002


30.9.2005


Note 3


Date expired
(30.11.2002)




CEN


EN 1060-2:1995
Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers


26.8.1996


 


 




EN 1060-2:1995/AC:2002


This is the first publication




CEN


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


9.5.1998


 


 




EN 1060-3:1997/A1:2005


2.6.2006


Note 3


Date expired
(30.6.2006)




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 1089-3:2004
Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour coding


30.9.2005


EN 1089-3:1997
Note 2.1


Date expired
(31.10.2004)




CEN


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


30.9.2005


EN 1282-2:1997
Note 2.1


Date expired
(31.12.2005)




CEN


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


This is the first publication


EN 1422:1997
Note 2.1


21.3.2010




CEN


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


9.5.1998


 


 




CEN


EN 1639:2004
Dentistry — Medical devices for dentistry — Instruments


30.9.2005


EN 1639:1996
Note 2.1


Date expired
(31.12.2004)




CEN


EN 1640:2004
Dentistry — Medical devices for dentistry — Equipment


30.9.2005


EN 1640:1996
Note 2.1


Date expired
(31.12.2004)




CEN


EN 1641:2004
Dentistry — Medical devices for dentistry — Materials


30.9.2005


EN 1641:1996
Note 2.1


Date expired
(31.12.2004)




CEN


EN 1642:2004
Dentistry — Medical devices for dentistry — Dental implants


30.9.2005


EN 1642:1996
Note 2.1


Date expired
(31.12.2004)




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
Tracheal tubes and connectors


30.9.2005


 


 




CEN


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


23.7.2008


EN 1789:1999
Note 2.1


Date expired
(30.11.2007)




CEN


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


30.9.2005


EN 1820:1997
Note 2.1


Date expired
(31.12.2005)




CEN


EN 1865:1999
Specifications for stretchers and other patient handling equipment used in road ambulances


14.10.2000


 


 




CEN


EN 1970:2000
Adjustable beds for disabled persons — Requirements and test methods


14.11.2001


 


 




EN 1970:2000/A1:2005


30.9.2005


Note 3


Date expired
(30.9.2005)




CEN


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


10.8.1999


 


 




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


This is the first publication




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 5356-2:2007
Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)


9.11.2007


EN 1281-2:1995
Note 2.1


Date expired
(29.2.2008)




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


30.6.2010




CEN


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


This is the first publication


EN ISO 5360:2007
Note 2.1


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)


This is the first publication


EN ISO 5366-1:2004
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 5840:2005
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 7197:2006
Note 2.1


21.3.2010




CEN


EN ISO 7376:2009
Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003)


This is the first publication


EN ISO 7376:2003
Note 2.1


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)




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 7439:2009
Copper-bearing intra-uterine contraceptive devices — Requirements, tests (ISO 7439:2002)


This is the first publication


EN ISO 7439:2002
Note 2.1


21.3.2010




CEN


EN ISO 7886-3:2005
Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunisation (ISO 7886-3:2005)


30.9.2005


 


 




CEN


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


9.8.2007


 


 




CEN


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


This is the first publication


EN ISO 8185:2007
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 8359:1996
Note 2.1


21.3.2010




CEN


EN ISO 8536-4:2007
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)


9.8.2007


 


 




CEN


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


This is the first publication


EN ISO 8835-2:2007
Note 2.1


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)


This is the first publication


EN ISO 8835-3:2007
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 8835-4:2004
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 8835-5:2004
Note 2.1


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


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


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)


This is the first publication


EN ISO 9360-1:2000
Note 2.1


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 tracheostomised patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)


This is the first publication


EN ISO 9360-2:2002
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 9713:2004
Note 2.1


21.3.2010




CEN


EN ISO 9919:2009
Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)


This is the first publication


EN ISO 9919:2005
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 10079-1:1999
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 10079-2:1999
Note 2.1


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)


This is the first publication


EN ISO 10079-3:1999
Note 2.1


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


 


 




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


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)




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)


This is the first publication


EN ISO 10555-1:1996
Note 2.1


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)


This is the first publication


EN ISO 10651-2:2004
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 10651-4:2002
Note 2.1


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)


This is the first publication


EN ISO 10651-6:2004
Note 2.1


21.3.2010




CEN


EN ISO 10993-1:2009
Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)


This is the first publication


EN ISO 10993-1:2003
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 10993-3:2003
Note 2.1


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)


This is the first publication


EN ISO 10993-4:2002
Note 2.1


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)


This is the first publication


EN ISO 10993-5:1999
Note 2.1


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)


This is the first publication


EN ISO 10993-6:2007
Note 2.1


21.3.2010




CEN


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


19.2.2009


 


 




CEN


EN ISO 10993-9:2009
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)


This is the first publication


EN ISO 10993-9:1999
Note 2.1


21.3.2010




CEN


EN ISO 10993-10:2009
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)


This is the first publication


EN ISO 10993-10:2002
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 10993-11:2006
Note 2.1


21.3.2010




CEN


EN ISO 10993-12:2009
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007)


This is the first publication


EN ISO 10993-12:2007
Note 2.1


21.3.2010




CEN


EN ISO 10993-13:2009
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)


This is the first publication


EN ISO 10993-13:1998
Note 2.1


21.3.2010




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)


This is the first publication


EN ISO 10993-14:2001
Note 2.1


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)


This is the first publication


EN ISO 10993-15:2000
Note 2.1


21.3.2010




CEN


EN ISO 10993-16:2009
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)


This is the first publication


EN ISO 10993-16:1997
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 10993-17:2002
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 10993-18:2005
Note 2.1


21.3.2010




CEN


EN ISO 11135-1:2007
Sterilisation of healthcare products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11135-1:2007)


9.8.2007


EN 550:1994
Note 2.1


31.5.2010




CEN


EN ISO 11137-1:2006
Sterilisation of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006)


7.9.2006


EN 552:1994
Note 2.1


Date expired
(30.4.2009)




CEN


EN ISO 11137-2:2007
Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01)


9.8.2007


 


 




EN ISO 11137-2:2007/AC:2009


This is the first publication




CEN


EN ISO 11138-2:2009
Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006)


This is the first publication


EN ISO 11138-2:2006
Note 2.1


21.3.2010




CEN


EN ISO 11138-3:2009
Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006)


This is the first publication


EN ISO 11138-3:2006
Note 2.1


21.3.2010




CEN


EN ISO 11140-1:2009
Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)


This is the first publication


EN ISO 11140-1:2005
Note 2.1


21.3.2010




CEN


EN ISO 11140-3:2009
Sterilisation of healthcare 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)


This is the first publication


EN ISO 11140-3:2007
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 11197:2004
Note 2.1


21.3.2010




CEN


EN ISO 11607-1:2009
Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)


This is the first publication


EN ISO 11607-1:2006
Note 2.1


21.3.2010




CEN


EN ISO 11607-2:2006
Packaging for terminally sterilised 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
Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of micro-organisms 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


This is the first publication




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)


This is the first publication


 


 




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)


This is the first publication


EN ISO 11810-2:2007
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 11979-8:2006
Note 2.1


21.3.2010




CEN


EN ISO 11990:2003
Optics and optical instruments — Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)


7.11.2003


EN ISO 11990:1999
Note 2.1


Date expired
(31.10.2003)




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


This is the first publication


EN 12006-2:1998
Note 2.1


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


This is the first publication


EN 12006-3:1998
Note 2.1


21.3.2010




CEN


EN 12182:1999
Technical aids for disabled persons — General requirements and test methods


14.10.2000


 


 




CEN


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


26.6.1999


 


 




CEN


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


This is the first publication


EN 12470-1:2000
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN 12470-2:2000
Note 2.1


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


This is the first publication


EN 12470-3:2000
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN 12470-4:2000
Note 2.1


21.3.2010




CEN


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


7.11.2003


 


 




CEN


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


This is the first publication


EN ISO 12870:2004
Note 2.1


21.3.2010




CEN


EN 13060:2004 + A1:2009
Small steam sterilisers


This is the first publication


EN 13060:2004
Note 2.1


21.3.2010




CEN


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


2.4.2004


EN ISO 13488:2000
EN ISO 13485:2000
EN 46003:1999
Note 2.1


Date expired
(31.7.2009)




EN ISO 13485:2003/AC:2007


9.8.2007




CEN


EN 13544-1:2007
Respiratory therapy equipment — Part 1: Nebulising systems and their components


9.8.2007


EN 13544-1:2001
Note 2.1


Date expired
(31.10.2007)




CEN


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


21.12.2002


 


 




CEN


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


30.9.2005


 


 




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


This is the first publication




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 13727:2003
Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1)


30.9.2005


 


 




CEN


EN 13795-1:2002
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products


19.2.2009


 


 




CEN


EN 13795-2:2004
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods


19.2.2009


 


 




CEN


EN 13795-3:2006
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels


19.2.2009


 


 




CEN


EN 13824:2004
Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements


30.9.2005


 


 




CEN


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


This is the first publication


EN 13867:2002
Note 2.1


21.3.2010




CEN


EN 13976-1:2003
Rescue systems — Transportation of incubators — Part 1: Interface conditions


30.9.2005


 


 




CEN


EN 13976-2:2003
Rescue systems — Transportation of incubators — Part 2: System requirements


30.9.2005


 


 




EN 13976-2:2003/AC:2004


This is the first publication




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 ISO 14155-1:2003
Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)


11.11.2003


EN 540:1993
Note 2.1


Date expired
(31.8.2003)




CEN


EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)


11.11.2003


 


 




CEN


EN ISO 14160:1998
Sterilisation of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilisation by liquid chemical sterilants (ISO 14160:1998)


27.8.1998


 


 




CEN


EN 14180:2003 + A1:2009
Sterilisers for medical purposes — Low temperature steam and formaldehyde sterilisers — Requirements and testing


This is the first publication


EN 14180:2003
Note 2.1


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)


This is the first publication


EN ISO 14408:2005
Note 2.1


21.3.2010




CEN


EN ISO 14534:2009
Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002)


This is the first publication


EN ISO 14534:2002
Note 2.1


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 14602:2009
Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:1998)


This is the first publication


EN ISO 14602:1998
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 14607:2007
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 14630:2008
Note 2.1


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)


This is the first publication


EN ISO 14889:2003
Note 2.1


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 14937:2000
Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000)


31.7.2002


 


 




EN ISO 14937:2000/AC:2005


This is the first publication




CEN


EN ISO 14971:2007
Medical devices — Application of risk management to medical devices (ISO 14971:2007)


9.8.2007


EN ISO 14971:2000
Note 2.1


31.3.2010




CEN


EN ISO 15001:2004
Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003)


30.9.2005


 


 




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


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)


This is the first publication


EN ISO 15004-1:2006
Note 2.1


21.3.2010




CEN


EN ISO 15225:2000
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)


31.7.2002


 


 




EN ISO 15225:2000/A1:2004


30.9.2005


Note 3


Date expired
(31.8.2004)




EN ISO 15225:2000/A2:2005


This is the first publication


Note 3


Date expired
(31.1.2006)




CEN


EN 15424:2007
Sterilisation of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilisation process for medical devices


9.8.2007


 


 




CEN


EN 15546-1:2008
Small bore connectors for liquids and gases in healthcare applications — Part 1 — General Requirements


23.7.2008


 


 




CEN


EN ISO 15747:2005
Plastics containers for intravenous injection (ISO 15747:2003)


30.9.2005


 


 




CEN


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


This is the first publication


EN ISO 15883-1:2006
Note 2.1


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)


This is the first publication


EN ISO 15883-2:2006
Note 2.1


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)


This is the first publication


EN ISO 15883-3:2006
Note 2.1


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)


This is the first publication


EN ISO 15883-4:2008
Note 2.1


21.3.2010




CEN


EN ISO 16061:2008
Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008)


19.2.2009


EN 12011:1998
Note 2.1


Date expired
(30.6.2009)




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)


This is the first publication


EN ISO 17510-1:2007
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 17510-2:2007
Note 2.1


21.3.2010




CEN


EN ISO 17664:2004
Sterilisation of medical devices — Information to be provided by the manufacturer for the processing of re-sterilisable medical devices (ISO 17664:2004)


30.9.2005


 


 




CEN


EN ISO 17665-1:2006
Sterilisation of healthcare products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation 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)


This is the first publication


EN ISO 18777:2005
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 18778:2005
Note 2.1


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


This is the first publication


 


 




CEN


EN ISO 21171:2006
Medical gloves — Determination of removable surface powder (ISO 21171:2006)


7.9.2006


 


 




CEN


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


This is the first publication


EN ISO 21534:2007
Note 2.1


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)


This is the first publication


EN ISO 21535:2007
Note 2.1


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)


This is the first publication


EN ISO 21536:2007
Note 2.1


21.3.2010




CEN


EN ISO 21647:2009
Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)


This is the first publication


EN ISO 21647:2004
Note 2.1


21.3.2010




CEN


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


7.9.2006


 


 




CEN


EN ISO 21969:2006
High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)


7.9.2006


EN 13221:2000
Note 2.1


Date expired
(31.12.2007)




CEN


EN ISO 22442-1:2007
Medical devices utilising 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 utilising 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 utilising 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)




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)


30.9.2005


 


 




CEN


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


9.8.2007


 


 




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)


This is the first publication


EN ISO 23328-2:2008
Note 2.1


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)


This is the first publication


EN ISO 23747:2007
Note 2.1


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)


This is the first publication


EN ISO 25539-1:2008
Note 2.1


21.3.2010




CEN


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


This is the first publication


EN ISO 25539-2:2008
Note 2.1


21.3.2010




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


This is the first publication


 


 




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)




Cenelec


EN 60522:1999
Determination of the permanent filtration of X-ray tube assemblies
IEC 60522:1999


14.11.2001


 


 




Cenelec


EN 60580:2000
Medical electrical equipment — Dose area product meters
IEC 60580:2000


13.12.2002


 


 




Cenelec


EN 60601-1:1990
Medical electrical equipment — Part 1: General requirements for safety
IEC 60601-1:1988


18.11.1995


 


 




EN 60601-1:1990/A1:1993
IEC 60601-1:1988/A1:1991


18.11.1995


Note 3




EN 60601-1:1990/A2:1995
IEC 60601-1:1988/A2:1995


18.11.1995


Note 3




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
Note 2.1


 




Cenelec


EN 60601-1-1:2001
Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-1:2000


14.11.2001


EN 60601-1-1:1993
+ A1:1996
Note 2.1


Date expired
(1.12.2003)




Cenelec


EN 60601-1-2:2001
Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-2:2001


13.12.2002


EN 60601-1-2:1993
Note 2.1


Date expired
(1.11.2004)




EN 60601-1-2:2001/A1:2006
IEC 60601-1-2:2001/A1:2004


22.12.2007


Note 3


Date expired
(1.3.2009)




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
and its amendment
Note 2.1


 




Cenelec


EN 60601-1-3:1994
Medical electrical equipment — Part 1: General requirements for safety — 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-1-3:1994


18.11.1995


 


 




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
(1.7.1995)




Cenelec


EN 60601-1-4:1996
Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems
IEC 60601-1-4:1996


8.11.1997


 


 




EN 60601-1-4:1996/A1:1999
IEC 60601-1-4:1996/A1:1999


8.11.1997


Note 3


Date expired
(1.12.2002)




Cenelec


EN 60601-1-6:2004
Medical electrical equipment — Part 1-6: General requirements for safety — Collateral standard: Usability
IEC 60601-1-6:2004


2.7.2006


 


 




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


 




Cenelec


EN 60601-1-8:2004
Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8:2003


22.12.2007


 


 




EN 60601-1-8:2004/A1:2006
IEC 60601-1-8:2003/A1:2006


22.12.2007


Note 3


Date expired
(1.1.2007)




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
and its amendment
Note 2.1


 




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


 


 




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)




Cenelec


EN 60601-2-2:2000
Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment
IEC 60601-2-2:1998


13.12.2002


EN 60601-2-2:1993
Note 2.1


Date expired
(1.8.2003)




Cenelec


EN 60601-2-2:2007
Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment
IEC 60601-2-2:2006


22.12.2007


EN 60601-2-2:2000
Note 2.1


Date expired
(1.10.2009)




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)




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


 


 




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


 


 




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


9.10.1999


 


 




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
(1.6.1998)




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)




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)




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


 


 




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)




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


 


 




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)




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)




Cenelec


EN 60601-2-19:1996
Medical electrical equipment — Part 2: Particular requirements for the safety of baby incubators
IEC 60601-2-19:1990


9.10.1999


 


 




EN 60601-2-19:1996/A1:1996
IEC 60601-2-19:1990/A1:1996


9.10.1999


Note 3


Date expired
(13.6.1998)




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


9.10.1999


 


 




Cenelec


EN 60601-2-21:1994
Medical electrical equipment — Part 2: Particular requirements for the safety of infant radiant warmers
IEC 60601-2-21:1994


18.11.1995


 


 




EN 60601-2-21:1994/A1:1996
IEC 60601-2-21:1994/A1:1996


23.8.2006


Note 3


Date expired
(13.6.1998)




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


 


 




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)




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


 


 




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)




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)




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)




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


 


 




Cenelec


EN 60601-2-29:1999
Medical electrical equipment — Part 2-29: Particular requirements for the safety of radiotherapy simulators
IEC 60601-2-29:1999


9.10.1999


EN 60601-2-29:1995
+ A1:1996
Note 2.1


Date expired
(1.4.2002)




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


1.11.2011




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
(1.2.2003)




Cenelec


EN 60601-2-31:1995
Medical electrical equipment — Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
IEC 60601-2-31:1994


18.11.1995


 


 




EN 60601-2-31:1995/A1:1998
IEC 60601-2-31:1994/A1:1998


14.11.2001


Note 3


Date expired
(1.1.2001)




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


 


 




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
(1.7.2005)




EN 60601-2-33:2002/A1:2005
IEC 60601-2-33:2002/A1:2005


27.7.2006


Note 3


Date expired
(1.11.2008)




EN 60601-2-33:2002/A2:2008
IEC 60601-2-33:2002/A2:2007


27.11.2008


Note 3


Date expired
(1.2.2011)




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)




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


9.10.1999


 


 




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


 


 




Cenelec


EN 60601-2-37:2001
Medical electrical equipment — Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37:2001


13.12.2002


 


 




EN 60601-2-37:2001/A1:2005
IEC 60601-2-37:2001/A1:2004


8.11.2005


Note 3


Date expired
(1.1.2008)




EN 60601-2-37:2001/A2:2005
IEC 60601-2-37:2001/A2:2005


26.7.2006


Note 3


Date expired
(1.12.2008)




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
and its amendments
Note 2.1


1.10.2010




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


9.10.1999


 


 




EN 60601-2-38:1996/A1:2000
IEC 60601-2-38:1996/A1:1999


14.11.2001


Note 3


Date expired
(1.1.2003)




Cenelec


EN 60601-2-39:1999
Medical electrical equipment — Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
IEC 60601-2-39:1999


14.11.2001


 


 




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


1.3.2011




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


 


 




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


 


 




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


 


 




Cenelec


EN 60601-2-44:2001
Medical electrical equipment — Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
IEC 60601-2-44:2001


14.11.2001


EN 60601-2-44:1999
Note 2.1


Date expired
(1.7.2004)




EN 60601-2-44:2001/A1:2003
IEC 60601-2-44:2001/A1:2002


8.11.2005


Note 3


Date expired
(1.12.2005)




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)




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


 


 




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


 


 




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


 


 




Cenelec


EN 60601-2-50:2002
Medical electrical equipment — Part 2-50: Particular requirements for the safety of infant phototherapy equipment
IEC 60601-2-50:2000


13.12.2002


 


 




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


 


 




Cenelec


EN 60627:2001
Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids
IEC 60627:2001


13.12.2002


 


 




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)




Cenelec


EN 60645-2:1997
Audiometers — Part 2: Equipment for speech audiometry
IEC 60645-2:1993


17.5.1997


 


 




Cenelec


EN 60645-3:1995
Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes
IEC 60645-3:1994


23.8.1996


 


 




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


1.6.2010




Cenelec


EN 60645-4:1995
Audiometers — Part 4: Equipment for extended high-frequency audiometry
IEC 60645-4:1994


23.8.1996


 


 




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)




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


 


 




Cenelec


EN 62083:2001
Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems
IEC 62083:2000


13.12.2002


 


 




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


 


 




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


 


 




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


 


 




Cenelec


EN 62304:2006
Medical device software — Software lifecycle processes
IEC 62304:2006


27.11.2008


 


 




Cenelec


EN 62366:2008
Medical devices — Application of usability engineering to medical devices
IEC 62366:2007


27.11.2008


 


 










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 requirements of the Directive.










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 requirements of the Directive.










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 requirements of the Directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the Directive for products 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 (column 3) 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 requirements of the Directive.




NOTE:






—


Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and of the Council (2) amended by the Directive 98/48/EC (3).










—


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










—


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










—


More information about harmonised standards on the Internet at http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/






(1)  CEN: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 25500811, fax: +32 25500819 (http://www.cen.eu).
Cenelec: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 25196871, fax: +32 25196919 (http://www.cenelec.eu).
ETSI: 650, route des Lucioles, 06921 Sophia Antipolis, FRANCE, tel. +33 492944200, fax: +33 493654716 (http://www.etsi.eu).

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.