MDD - 医疗器械指令
Directive 93/42/EEC 医疗器械MDD指令欧盟为消除各成员国间的贸易壁垒，逐步建立成为一个统一的大市场，以确保人员、服务、资金和产品（如医疗器械）的自由流通。在医疗器械领域，欧盟委员会制定了三个欧盟指令，以替代原来各成员的认可体系，使有关这类产品投放市场的规定协调一致。
这三个指令分别是：
Medical devices Directive - MDD Directive 93/42/EEC
In vitro diagnostic medical devices - IVD Directive 98/79/EC
Active implantable medical devices - AIMD Directive 90/385/EEC
有源植入性医疗器械指令（AIMD，90/335/EEC），适用于心脏起搏器，可植入的胰岛素泵等有源植入性医疗器械。AIMD于1993年1月1日生效。过渡截止期为1994年12月31日，从1995年1月1日强制实施。
IVD活体外诊断器械指令，适用于血细胞计数器，妊娠检测装置等活体外诊断用医疗器械。
MDD医疗器械指令（MedicalDevicesDirective，93/42/EEC），适用范围很广，包括除有源植入性和体外诊断器械之外的几乎所有的医疗器械，如无源性医疗器械（敷料、一次性使用产品、接触镜、血袋、导管等）；以及有源性医疗器械，如核磁共振仪、超声诊断和治疗仪、输液泵等。该指令已于1995年1月1日生效，过渡截止日期为1998年6月13日从1998年6月14日起强制执行。
上述指令规定，在指令正式实施后，只有带有CE标志的医疗器械产品才能在欧盟市场上销售。
ESO (1)Reference and title of the standard
(and reference document)First publication OJReference of superseded standardDate of cessation of presumption of conformity of superseded standard
Note 1
CENEN 285:2006+A2:2009Sterilization - Steam sterilizers - Large sterilizers02/12/2009 EN 285:2006+A1:2008
Note 2.121/03/2010
CENEN 455-1:2000Medical gloves for single use - Part 1: Requirements and testing for freedom from holes30/09/2005 EN 455-1:1993
Note 2.130/04/2001
CENEN 455-2:2009+A2:2013Medical gloves for single use - Part 2: Requirements and testing for physical properties16/05/2014 EN 455-2:2009+A1:2011
Note 2.131/10/2014
CENEN 455-3:2006Medical gloves for single use - Part 3: Requirements and testing for biological evaluation09/08/2007 EN 455-3:1999
Note 2.130/06/2007
CENEN 455-4:2009Medical gloves for single use - Part 4: Requirements and testing for shelf life determination07/07/2010
CENEN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices31/07/2002 EN 556:1994 + A1:1998
Note 2.130/04/2002
EN 556-1:2001/AC:2006
15/11/2006
CENEN 556-2:2015Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices13/05/2016 EN 556-2:2003
Note 2.130/06/2016
CENEN 794-3:1998+A2:2009Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators07/07/2010 EN 794-3:1998
Note 2.121/03/2010
CENEN 1041:2008Information supplied by the manufacturer of medical devices19/02/2009 EN 1041:1998
Note 2.131/08/2011
CENEN 1060-3:1997+A2:2009Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems07/07/2010 EN 1060-3:1997
Note 2.131/05/2010
CENEN 1060-4:2004Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers30/09/2005
CENEN ISO 1135-4:2011Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)27/04/2012 EN ISO 1135-4:2010
Note 2.130/04/2012
CENEN 1282-2:2005+A1:2009Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)07/07/2010 EN 1282-2:2005
Note 2.121/03/2010
CENEN 1422:1997+A1:2009Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods02/12/2009 EN 1422:1997
Note 2.121/03/2010
CENEN 1618:1997Catheters other than intravascular catheters - Test methods for common properties09/05/1998
CENEN 1639:2009Dentistry - Medical devices for dentistry - Instruments07/07/2010 EN 1639:2004
Note 2.130/04/2010
CENEN 1640:2009Dentistry - Medical devices for dentistry - Equipment07/07/2010 EN 1640:2004
Note 2.130/04/2010
CENEN 1641:2009Dentistry - Medical devices for dentistry - Materials07/07/2010 EN 1641:2004
Note 2.130/04/2010
CENEN 1642:2011Dentistry - Medical devices for dentistry - Dental implants27/04/2012 EN 1642:2009
Note 2.130/04/2012
CENEN 1707:1996Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings17/05/1997
CENEN 1782:1998+A1:2009Tracheal tubes and connectors07/07/2010 EN 1782:1998
Note 2.121/03/2010
CENEN 1789:2007+A1:2010Medical vehicles and their equipment - Road ambulances18/01/2011
CENEN 1820:2005+A1:2009Anaesthetic reservoir bags (ISO 5362:2000, modified)07/07/2010 EN 1820:2005
Note 2.121/03/2010
CENEN 1865-1:2010+A1:2015Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment13/05/2016
CENEN 1865-2:2010+A1:2015Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher13/05/2016
CENEN 1865-3:2012Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher30/08/2012 EN 1865:1999
Note 2.131/12/2012
CENEN 1865-4:2012Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair30/08/2012 EN 1865:1999
Note 2.131/10/2012
CENEN 1865-5:2012Patient handling equipment used in road ambulances - Part 5: Stretcher support30/08/2012 EN 1865:1999
Note 2.131/12/2012
CENEN 1985:1998Walking aids - General requirements and test methods10/08/1999
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CENEN ISO 3826-2:2008Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)19/02/2009
CENEN ISO 3826-3:2007Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)27/02/2008
CENEN ISO 3826-4:2015Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)13/05/2016
CENEN ISO 4074:2002Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)31/07/2002 EN 600:1996
Note 2.131/08/2005
CENEN ISO 4135:2001Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)31/07/2002 EN ISO 4135:1996
Note 2.128/02/2002
CENEN ISO 5359:2008Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)23/07/2008 EN 739:1998
Note 2.130/06/2010
EN ISO 5359:2008/A1:2011
30/08/2012 Note 330/06/2012
CENEN ISO 5360:2009Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)02/12/2009 EN ISO 5360:2007
Note 2.121/03/2010
CENEN ISO 5366-1:2009Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)02/12/2009 EN ISO 5366-1:2004
Note 2.121/03/2010
CENEN ISO 5840:2009Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)02/12/2009 EN ISO 5840:2005
Note 2.121/03/2010
CENEN ISO 7197:2009Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)02/12/2009 EN ISO 7197:2006
Note 2.121/03/2010
CENEN ISO 7376:2009Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)02/12/2009 EN ISO 7376:2009
Note 2.121/03/2010
CENEN ISO 7396-1:2007Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)09/08/2007 EN 737-3:1998
Note 2.130/04/2009
EN ISO 7396-1:2007/A1:2010
07/07/2010 Note 331/07/2010
EN ISO 7396-1:2007/A2:2010
07/07/2010 Note 331/08/2010
CENEN ISO 7396-2:2007Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)09/08/2007 EN 737-2:1998
Note 2.130/04/2009
CENEN ISO 7886-3:2009Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)07/07/2010 EN ISO 7886-3:2005
Note 2.121/03/2010
CENEN ISO 7886-4:2009Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)07/07/2010 EN ISO 7886-4:2006
Note 2.121/03/2010
CENEN ISO 8185:2009Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)02/12/2009 EN ISO 8185:2007
Note 2.121/03/2010
CENEN ISO 8359:2009Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)02/12/2009 EN ISO 8359:1996
Note 2.121/03/2010
EN ISO 8359:2009/A1:2012
16/01/2015 Note 331/01/2013
CENEN ISO 8835-2:2009Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)02/12/2009 EN ISO 8835-2:2007
Note 2.121/03/2010
CENEN ISO 8835-3:2009Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)02/12/2009 EN ISO 8835-3:2007
Note 2.121/03/2010
EN ISO 8835-3:2009/A1:2010
13/05/2011 Note 330/04/2011
CENEN ISO 8835-4:2009Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)02/12/2009 EN ISO 8835-4:2004
Note 2.121/03/2010
CENEN ISO 8835-5:2009Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)02/12/2009 EN ISO 8835-5:2004
Note 2.121/03/2010
CENEN ISO 9170-1:2008Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)19/02/2009 EN 737-1:1998
Note 2.131/07/2010
CENEN ISO 9170-2:2008Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)19/02/2009 EN 737-4:1998
Note 2.131/07/2010
CENEN ISO 9360-1:2009Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)02/12/2009 EN ISO 9360-1:2000
Note 2.121/03/2010
CENEN ISO 9360-2:2009Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)02/12/2009 EN ISO 9360-2:2002
Note 2.121/03/2010
CENEN ISO 9713:2009Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)02/12/2009 EN ISO 9713:2004
Note 2.121/03/2010
CENEN ISO 10079-1:2009Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)02/12/2009 EN ISO 10079-1:1999
Note 2.121/03/2010
CENEN ISO 10079-2:2009Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)02/12/2009 EN ISO 10079-2:1999
Note 2.121/03/2010
CENEN ISO 10079-3:2009Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)02/12/2009 EN ISO 10079-3:1999
Note 2.121/03/2010
CENEN ISO 10328:2016 (new)Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)This is the first publicationEN ISO 10328:2006
Note 2.130/06/2018
CENEN ISO 10524-1:2006Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)02/06/2006 EN 738-1:1997
Note 2.131/10/2008
CENEN ISO 10524-2:2006Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)07/06/2009 EN 738-2:1998
Note 2.131/10/2008
CENEN ISO 10524-3:2006Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)07/09/2006 EN 738-3:1998
Note 2.131/10/2008
CENEN ISO 10524-4:2008Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)23/07/2008 EN 738-4:1998
Note 2.130/06/2010
CENEN ISO 10535:2006Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)09/08/2007 EN ISO 10535:1998
Note 2.130/06/2007
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CENEN ISO 10555-1:2009Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)02/12/2009 EN ISO 10555-1:1996
Note 2.121/03/2010
CENEN ISO 10651-2:2009Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)02/12/2009 EN ISO 10651-2:2004
Note 2.121/03/2010
CENEN ISO 10651-4:2009Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)02/12/2009 EN ISO 10651-4:2002
Note 2.121/03/2010
CENEN ISO 10651-6:2009Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)02/12/2009 EN ISO 10651-6:2004
Note 2.121/03/2010
CENEN ISO 10993-1:2009Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)02/12/2009 EN ISO 10993-1:2009
Note 2.121/03/2010
EN ISO 10993-1:2009/AC:2010
18/01/2011
CENEN ISO 10993-3:2014Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)10/07/2015 EN ISO 10993-3:2009
Note 2.1The date of this publication
()
CENEN ISO 10993-4:2009Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)02/12/2009 EN ISO 10993-4:2002
Note 2.121/03/2010
CENEN ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)02/12/2009 EN ISO 10993-5:1999
Note 2.131/12/2009
CENEN ISO 10993-6:2009Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)02/12/2009 EN ISO 10993-6:2007
Note 2.121/03/2010
CENEN ISO 10993-7:2008Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)19/02/2009
EN ISO 10993-7:2008/AC:2009
07/07/2010
CENEN ISO 10993-9:2009Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)02/12/2009 EN ISO 10993-9:2009
Note 2.121/03/2010
CENEN ISO 10993-11:2009Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)02/12/2009 EN ISO 10993-11:2006
Note 2.121/03/2010
CENEN ISO 10993-12:2012Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)24/01/2013 EN ISO 10993-12:2009
Note 2.131/01/2013
CENEN ISO 10993-13:2010Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)18/01/2011 EN ISO 10993-13:2009
Note 2.131/12/2010
CENEN ISO 10993-14:2009Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)02/12/2009 EN ISO 10993-14:2001
Note 2.121/03/2010
CENEN ISO 10993-15:2009Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)02/12/2009 EN ISO 10993-15:2000
Note 2.121/03/2010
CENEN ISO 10993-16:2010Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)07/07/2010 EN ISO 10993-16:2009
Note 2.131/08/2010
CENEN ISO 10993-17:2009Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)02/12/2009 EN ISO 10993-17:2002
Note 2.121/03/2010
CENEN ISO 10993-18:2009Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)02/12/2009 EN ISO 10993-18:2005
Note 2.121/03/2010
CENEN ISO 11135-1:2007Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)09/08/2007 EN 550:1994
Note 2.131/05/2010
CENEN ISO 11137-1:2015Sterilization 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, including Amd 1:2013)13/05/2016 EN ISO 11137-1:2006
Note 2.130/06/2016
CENEN ISO 11137-2:2015Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)13/05/2016 EN ISO 11137-2:2013
Note 2.130/06/2016
CENEN ISO 11138-2:2009Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)02/12/2009 EN ISO 11138-2:2006
Note 2.121/03/2010
CENEN ISO 11138-3:2009Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)02/12/2009 EN ISO 11138-3:2006
Note 2.121/03/2010
CENEN ISO 11140-1:2009Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)02/12/2009 EN ISO 11140-1:2005
Note 2.121/03/2010
CENEN ISO 11140-3:2009Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)02/12/2009 EN ISO 11140-3:2007
Note 2.121/03/2010
CENEN ISO 11197:2009Medical supply units (ISO 11197:2004)02/12/2009 EN ISO 11197:2004
Note 2.121/03/2010
CENEN ISO 11607-1:2009Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)02/12/2009 EN ISO 11607-1:2006
Note 2.121/03/2010
CENEN ISO 11607-2:2006Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)07/09/2006
CENEN ISO 11737-1:2006Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)07/09/2006 EN 1174-1:1996
EN 1174-2:1996
EN 1174-3:1996
Note 2.131/10/2006
EN ISO 11737-1:2006/AC:2009
02/12/2009
CENEN ISO 11737-2:2009Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)07/07/2010
CENEN ISO 11810-1:2009Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)02/12/2009
CENEN ISO 11810-2:2009Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)02/12/2009 EN ISO 11810-2:2007
Note 2.121/03/2010
CENEN ISO 11979-8:2009Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)02/12/2009 EN ISO 11979-8:2006
Note 2.121/03/2010
CENEN ISO 11990-1:2014Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)10/07/2015
CENEN ISO 11990-2:2014Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)10/07/2015
CENEN 12006-2:1998+A1:2009Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits02/12/2009 EN 12006-2:1998
Note 2.121/03/2010
CENEN 12006-3:1998+A1:2009Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices02/12/2009 EN 12006-3:1998
Note 2.121/03/2010
CENEN 12183:2009Manual wheelchairs - Requirements and test methods07/07/2010
CENEN 12184:2009Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods07/07/2010
CENEN 12342:1998+A1:2009Breathing tubes intended for use with anaesthetic apparatus and ventilators07/07/2010 EN 12342:1998
Note 2.121/03/2010
CENEN 12470-1:2000+A1:2009Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device02/12/2009 EN 12470-1:2000
Note 2.121/03/2010
CENEN 12470-2:2000+A1:2009Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers02/12/2009 EN 12470-2:2000
Note 2.121/03/2010
CENEN 12470-3:2000+A1:2009Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device02/12/2009 EN 12470-3:2000
Note 2.121/03/2010
CENEN 12470-4:2000+A1:2009Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement02/12/2009 EN 12470-4:2000
Note 2.121/03/2010
CENEN 12470-5:2003Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)07/11/2003
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CENEN ISO 12870:2009Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)02/12/2009 EN ISO 12870:2004
Note 2.121/03/2010
CENEN 13060:2014Small steam sterilizers10/07/2015 EN 13060:2004+A2:2010
Note 2.1The date of this publication
()
CENEN ISO 13408-1:2015Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)13/05/2016 EN ISO 13408-1:2011
Note 2.130/06/2016
CENEN ISO 13408-2:2011Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)19/08/2011 EN 13824:2004
Note 2.131/12/2011
CENEN ISO 13408-3:2011Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)19/08/2011 EN 13824:2004
Note 2.131/12/2011
CENEN ISO 13408-4:2011Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)19/08/2011 EN 13824:2004
Note 2.131/12/2011
CENEN ISO 13408-5:2011Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)19/08/2011 EN 13824:2004
Note 2.131/12/2011
CENEN ISO 13408-6:2011Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)19/08/2011 EN 13824:2004
Note 2.131/12/2011
CENEN ISO 13408-7:2015Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)13/05/2016
CENEN ISO 13485:2016 (new)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)This is the first publicationEN ISO 13485:2012
Note 2.131/03/2019
EN ISO 13485:2016/AC:2016 (new)
This is the first publication
CENEN 13544-1:2007+A1:2009Respiratory therapy equipment - Part 1: Nebulizing systems and their components07/07/2010 EN 13544-1:2007
Note 2.121/03/2010
CENEN 13544-2:2002+A1:2009Respiratory therapy equipment - Part 2: Tubing and connectors07/07/2010 EN 13544-2:2002
Note 2.121/03/2010
CENEN 13544-3:2001+A1:2009Respiratory therapy equipment - Part 3: Air entrainment devices07/07/2010 EN 13544-3:2001
Note 2.121/03/2010
CENEN 13624:2003Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)30/09/2005
CENEN 13718-1:2008Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances19/02/2009 EN 13718-1:2002
Note 2.128/02/2009
CENEN 13718-2:2015Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances10/07/2015
CENEN 13726-1:2002Test methods for primary wound dressings - Part 1: Aspects of absorbency27/03/2003
EN 13726-1:2002/AC:2003
02/12/2009
CENEN 13726-2:2002Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings27/03/2003
CENEN 13727:2012Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)30/08/2012 EN 13727:2003
Note 2.130/11/2012
CENEN 13867:2002+A1:2009Concentrates for haemodialysis and related therapies02/12/2009 EN 13867:2002
Note 2.121/03/2010
CENEN 13976-1:2011Rescue systems - Transportation of incubators - Part 1: Interface conditions19/08/2011 EN 13976-1:2003
Note 2.130/11/2011
CENEN 13976-2:2011Rescue systems - Transportation of incubators - Part 2: System requirements19/08/2011 EN 13976-2:2003
Note 2.130/11/2011
CENEN 14079:2003Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze30/09/2005
CENEN 14139:2010Ophthalmic optics - Specifications for ready-to-wear spectacles18/01/2011
CENEN ISO 14155:2011Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)27/04/2012 EN ISO 14155:2011
Note 2.130/04/2012
EN ISO 14155:2011/AC:2011 (new)
This is the first publication
CENEN 14180:2003+A2:2009Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing07/07/2010 EN 14180:2003+A1:2009
Note 2.121/03/2010
CENEN 14348:2005Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)30/09/2005
CENEN ISO 14408:2009Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)02/12/2009 EN ISO 14408:2005
Note 2.121/03/2010
CENEN 14561:2006Chemical 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
CENEN 14562:2006Chemical 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
CENEN 14563:2008Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)19/02/2009
CENEN ISO 14602:2011Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)27/04/2012 EN ISO 14602:2010
Note 2.130/04/2012
CENEN ISO 14607:2009Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)02/12/2009 EN ISO 14607:2007
Note 2.121/03/2010
CENEN ISO 14630:2009Non-active surgical implants - General requirements (ISO 14630:2008)02/12/2009 EN ISO 14630:2008
Note 2.121/03/2010
CENEN 14683:2005Surgical masks - Requirements and test methods02/06/2006
CENEN ISO 14889:2009Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)02/12/2009 EN ISO 14889:2003
Note 2.121/03/2010
CENEN 14931:2006Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing15/11/2006
CENEN ISO 14937:2009Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)07/07/2010 EN ISO 14937:2000
Note 2.130/04/2010
CENEN ISO 14971:2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)30/08/2012 EN ISO 14971:2009
Note 2.130/08/2012
CENEN ISO 15001:2011Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)27/04/2012 EN ISO 15001:2010
Note 2.130/04/2012
CENEN ISO 15002:2008Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)19/02/2009 EN 13220:1998
Note 2.131/07/2010
CENEN ISO 15004-1:2009Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)02/12/2009 EN ISO 15004-1:2006
Note 2.121/03/2010
CENEN ISO 15223-1:2016 (new)Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)This is the first publicationEN 980:2008
Note 2.131/12/2017
CENEN ISO 15747:2011Plastic containers for intravenous injections (ISO 15747:2010)27/04/2012 EN ISO 15747:2010
Note 2.130/04/2012
CENEN ISO 15798:2010Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)07/07/2010
CENEN ISO 15883-1:2009Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)02/12/2009 EN ISO 15883-1:2006
Note 2.121/03/2010
CENEN ISO 15883-2:2009Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)02/12/2009 EN ISO 15883-2:2006
Note 2.121/03/2010
CENEN ISO 15883-3:2009Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)02/12/2009 EN ISO 15883-3:2006
Note 2.121/03/2010
CENEN ISO 15883-4:2009Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)02/12/2009 EN ISO 15883-4:2008
Note 2.121/03/2010
CENEN 15986:2011Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates13/05/2011
CENEN ISO 16061:2009Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)07/07/2010 EN ISO 16061:2008
Note 2.128/02/2010
CENEN ISO 16201:2006Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)19/02/2009
CENEN ISO 17510-1:2009Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)02/12/2009 EN ISO 17510-1:2007
Note 2.121/03/2010
CENEN ISO 17510-2:2009Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)02/12/2009 EN ISO 17510-2:2007
Note 2.121/03/2010
CENEN ISO 17664:2004Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)30/09/2005
CENEN ISO 17665-1:2006Sterilization 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 2.131/08/2009
CENEN ISO 18777:2009Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)02/12/2009 EN ISO 18777:2005
Note 2.121/03/2010
CENEN ISO 18778:2009Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)02/12/2009 EN ISO 18778:2005
Note 2.121/03/2010
CENEN ISO 18779:2005Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)30/09/2005
CENEN ISO 19054:2006Rail systems for supporting medical equipment (ISO 19054:2005)07/09/2006 EN 12218:1998
Note 2.130/06/2008
CENEN 20594-1:1993Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)18/11/1995
EN 20594-1:1993/A1:1997
10/08/1999 Note 331/05/1998
EN 20594-1:1993/AC:1996
02/12/2009
CENEN ISO 21534:2009Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)02/12/2009 EN ISO 21534:2007
Note 2.121/03/2010
CENEN ISO 21535:2009Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)02/12/2009 EN ISO 21535:2007
Note 2.121/03/2010
CENEN ISO 21536:2009Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)02/12/2009 EN ISO 21536:2007
Note 2.121/03/2010
CENEN ISO 21649:2009Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)07/07/2010 EN ISO 21649:2006
Note 2.121/03/2010
CENEN ISO 21969:2009High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)07/07/2010 EN ISO 21969:2006
Note 2.131/05/2010
CENEN ISO 21987:2009Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)07/07/2010
CENEN ISO 22442-1:2007Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)27/02/2008 EN 12442-1:2000
Note 2.130/06/2008
CENEN ISO 22442-2:2007Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)27/02/2008 EN 12442-2:2000
Note 2.130/06/2008
CENEN ISO 22442-3:2007Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)27/02/2008 EN 12442-3:2000
Note 2.130/06/2008
CENEN ISO 22523:2006External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)09/08/2007 EN 12523:1999
Note 2.130/04/2007
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CENEN ISO 22675:2016 (new)Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)This is the first publicationEN ISO 22675:2006
Note 2.130/06/2018
CENEN ISO 23328-1:2008Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)19/02/2009 EN 13328-1:2001
Note 2.130/09/2008
CENEN ISO 23328-2:2009Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)02/12/2009 EN ISO 23328-2:2008
Note 2.121/03/2010
CENEN ISO 23747:2009Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)02/12/2009 EN ISO 23747:2007
Note 2.121/03/2010
CENEN ISO 25539-1:2009Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)02/12/2009 EN 12006-3:1998+A1:2009
EN ISO 25539-1:2008
Note 2.121/03/2010
EN ISO 25539-1:2009/AC:2011
30/08/2012
CENEN ISO 25539-2:2009Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)02/12/2009 EN 12006-3:1998+A1:2009
EN ISO 25539-2:2008
Note 2.121/03/2010
EN ISO 25539-2:2009/AC:2011
30/08/2012
CENEN ISO 26782:2009Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)07/07/2010
EN ISO 26782:2009/AC:2009
07/07/2010
CENEN 27740:1992Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)18/11/1995
EN 27740:1992/A1:1997
10/08/1999 Note 331/05/1998
EN 27740:1992/AC:1996
02/12/2009
CENEN ISO 81060-1:2012Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)30/08/2012 EN 1060-1:1995+A2:2009
EN 1060-2:1995+A1:2009
Note 2.131/05/2015
CenelecEN 60118-13:2005Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC)
IEC 60118-13:200419/01/2006 EN 60118-13:1997
Note 2.101/02/2008
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60522:1999Determination of the permanent filtration of X-ray tube assemblies
IEC 60522:199914/11/2001
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60580:2000Medical electrical equipment - Dose area product meters
IEC 60580:200013/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-1:2006Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1:200527/11/2008 EN 60601-1:1990# + A13:1996# + A1:1993# + A2:1995
EN 60601-1-1:2001
EN 60601-1-4:1996# + A1:1999
Note 2.101/06/2012
EN 60601-1:2006/AC:2010
18/01/2011
EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012
16/05/2014 Note 331/12/2017
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 01/01/2016, 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.
CenelecEN 60601-1-1:2001Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-1:200014/11/2001 EN 60601-1-1:1993
+ A1:1996
Note 2.101/11/2003
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-1-2:2015Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-2:201413/05/2016 EN 60601-1-2:2007
Note 2.131/12/2018
CenelecEN 60601-1-3:2008Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-3:200827/11/2008 EN 60601-1-3:1994
Note 2.101/06/2012
EN 60601-1-3:2008/AC:2010
18/01/2011
EN 60601-1-3:2008/A11:2016 (new)
This is the first publicationNote 301/11/2019
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-1-4:1996Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
IEC 60601-1-4:199608/11/1997
EN 60601-1-4:1996/A1:1999
IEC 60601-1-4:1996/A1:1999
08/11/1997 Note 301/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-1-6:2010Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-6:201018/01/2011 EN 60601-1-6:2007
Note 2.101/04/2013
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-1-8:2007Medical 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 60601-1-8:200627/11/2008 EN 60601-1-8:2004
+ A1:2006
Note 2.101/06/2012
EN 60601-1-8:2007/AC:2010
18/01/2011
EN 60601-1-8:2007/A11:2017 (new)
This is the first publicationNote 307/01/2020
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-1-10:2008Medical 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 60601-1-10:200727/11/2008
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-1-11:2010Medical 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 60601-1-11:201018/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-1:1998Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
IEC 60601-2-1:199814/11/2001
EN 60601-2-1:1998/A1:2002
IEC 60601-2-1:1998/A1:2002
13/12/2002 Note 301/06/2005
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-2:2009Medical 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 60601-2-2:200907/07/2010 EN 60601-2-2:2007
Note 2.101/04/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-3:1993Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment
IEC 60601-2-3:199118/11/1995
EN 60601-2-3:1993/A1:1998
IEC 60601-2-3:1991/A1:1998
18/11/1995 Note 301/07/2001
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-4:2003Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators
IEC 60601-2-4:200215/10/2003
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-5:2000Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
IEC 60601-2-5:200013/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-8:1997Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
IEC 60601-2-8:198714/11/2001
EN 60601-2-8:1997/A1:1997
IEC 60601-2-8:1987/A1:1997
14/11/2001 Note 301/07/1998
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-10:2000Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-2-10:198713/12/2002
EN 60601-2-10:2000/A1:2001
IEC 60601-2-10:1987/A1:2001
13/12/2002 Note 301/11/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-11:1997Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
IEC 60601-2-11:199709/10/1999
EN 60601-2-11:1997/A1:2004
IEC 60601-2-11:1997/A1:2004
09/10/1999 Note 301/09/2007
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-12:2006Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
IEC 60601-2-12:200122/12/2007
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-13:2006Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
IEC 60601-2-13:200322/12/2007
EN 60601-2-13:2006/A1:2007
IEC 60601-2-13:2003/A1:2006
22/12/2007 Note 301/03/2010
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-16:1998Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:199809/10/1999
EN 60601-2-16:1998/AC:1999
18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-17:2004Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
IEC 60601-2-17:200408/11/2005 EN 60601-2-17:1996
+ A1:1996
Note 2.101/03/2007
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-18:1996Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
IEC 60601-2-18:199609/10/1999
EN 60601-2-18:1996/A1:2000
IEC 60601-2-18:1996/A1:2000
09/10/1999 Note 301/08/2003
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-19:2009Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601
IEC 60601-2-19:200907/07/2010 EN 60601-2-19:1996
+ A1:1996
Note 2.101/04/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-20:2009Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
IEC 60601
IEC 60601-2-20:200918/01/2011 EN 60601-2-20:1996
Note 2.101/09/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-21:2009Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-21:200907/07/2010 EN 60601-2-21:1994
+ A1:1996
Note 2.101/04/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-22:1996Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60601-2-22:199517/05/1997
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-23:2000Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
IEC 60601-2-23:199914/11/2001 EN 60601-2-23:1997
Note 2.101/01/2003
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-24:1998Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
IEC 60601-2-24:199809/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-25:1995Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
IEC 60601-2-25:199317/05/1997
EN 60601-2-25:1995/A1:1999
IEC 60601-2-25:1993/A1:1999
13/12/2002 Note 301/05/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-26:2003Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
IEC 60601-2-26:200208/11/2005 EN 60601-2-26:1994
Note 2.101/03/2006
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-27:2006Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
IEC 60601-2-27:200526/07/2006 EN 60601-2-27:1994
Note 2.101/11/2008
EN 60601-2-27:2006/AC:2006
18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-28:2010Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-28:201018/01/2011 EN 60601-2-28:1993
Note 2.101/04/2013
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-29:2008Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
IEC 60601-2-29:200815/07/2009 EN 60601-2-29:1999
Note 2.101/11/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-30:2000Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
IEC 60601-2-30:199914/11/2001 EN 60601-2-30:1995
Note 2.101/02/2003
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-33:2010 (new)Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601
IEC 60601-2-33:2010This is the first publicationEN 60601-2-33:2002
+ A1:2005
+ A2:2008
Note 2.131/12/2017
EN 60601-2-33:2010/A1:2015
IEC 60601-2-33:2010/A1:2013 (new)
This is the first publicationNote 314/04/2018
EN 60601-2-33:2010/A2:2015
IEC 60601-2-33:2010/A2:2015 (new)
This is the first publicationNote 323/07/2018
EN 60601-2-33:2010/AC:2016-03 (new)
This is the first publication
EN 60601-2-33:2010/A12:2016 (new)
This is the first publicationNote 301/11/2019
CenelecEN 60601-2-34:2000Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
IEC 60601-2-34:200015/10/2003 EN 60601-2-34:1995
Note 2.101/11/2003
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-36:1997Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
IEC 60601-2-36:199709/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-37:2008Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37:200727/11/2008 EN 60601-2-37:2001
+ A1:2005
+ A2:2005
Note 2.101/10/2010
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-39:2008Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
IEC 60601-2-39:200727/11/2008 EN 60601-2-39:1999
Note 2.101/03/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-40:1998Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
IEC 60601-2-40:199809/10/1999
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-41:2009Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
IEC 60601-2-41:200918/01/2011 EN 60601-2-41:2000
Note 2.101/11/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-43:2010Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
IEC 60601-2-43:201018/01/2011 EN 60601-2-43:2000
Note 2.101/06/2013
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-44:2009Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-2-44:200907/07/2010 EN 60601-2-44:2001
+ A1:2003
Note 2.101/05/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-45:2001Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
IEC 60601-2-45:200114/11/2001 EN 60601-2-45:1998
Note 2.101/07/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-46:1998Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tables
IEC 60601-2-46:199814/11/2001
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-47:2001Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
IEC 60601-2-47:200113/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-49:2001Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
IEC 60601-2-49:200113/12/2002
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-50:2009Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
IEC 60601-2-50:200907/07/2010 EN 60601-2-50:2002
Note 2.101/05/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-51:2003Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
IEC 60601-2-51:200324/06/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-52:2010Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)13/05/2011 EN 1970:2000# + A1:2005
EN 60601-2-38:1996# + A1:2000
Note 2.101/06/2012
EN 60601-2-52:2010/AC:2011
30/08/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60601-2-54:2009Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-54:200918/01/2011 EN 60601-2-7:1998
EN 60601-2-28:1993
EN 60601-2-32:1994
Note 2.101/08/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60627:2001Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
IEC 60627:200113/12/2002
EN 60627:2001/AC:2002
18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60645-1:2001Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers
IEC 60645-1:200113/12/2002 EN 60645-1:1994
Note 2.101/10/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60645-2:1997Audiometers - Part 2: Equipment for speech audiometry
IEC 60645-2:199317/05/1997
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60645-3:2007Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration
IEC 60645-3:200727/11/2008 EN 60645-3:1995
Note 2.101/06/2010
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 60645-4:1995Audiometers - Part 4: Equipment for extended high-frequency audiometry
IEC 60645-4:199423/08/1996
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 61217:2012Radiotherapy equipment - Coordinates, movements and scales
IEC 61217:201130/08/2012 EN 61217:1996
+ A1:2001
+ A2:2008
Note 2.111/01/2015
CenelecEN 61676:2002Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
IEC 61676:200215/10/2003
EN 61676:2002/A1:2009
IEC 61676:2002/A1:2008
07/07/2010 Note 301/03/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 62083:2009Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
IEC 62083:200918/01/2011 EN 62083:2001
Note 2.101/11/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 62220-1:2004Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
IEC 62220-1:200324/06/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 62220-1-2:2007Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
IEC 62220-1-2:200727/11/2008
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 62220-1-3:2008Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
IEC 62220-1-3:200815/07/2009
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 62304:2006Medical device software - Software life-cycle processes
IEC 62304:200627/11/2008
EN 62304:2006/AC:2008
18/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 62366:2008Medical devices - Application of usability engineering to medical devices
IEC 62366:200727/11/2008
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 80601-2-35:2009Medical 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 80601-2-35:200918/01/2011 EN 60601-2-35:1996
Note 2.101/11/2012
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 80601-2-58:2009Medical 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 80601-2-58:200807/07/2010
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CenelecEN 80601-2-59:2009Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
IEC 80601
IEC 80601-2-59:200818/01/2011
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
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