Normativa Armonizada
Normativa armonizada con la directiva 93/42/EEC
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
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ESO(1) |
Reference and title of the standard |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard |
| CEN | EN 285:2006+A2:2009
Sterilization – Steam sterilizers – Large sterilizers |
02/12/2009 |
EN 285:2006+A1:2008 |
21/03/2010 |
| CEN | EN 455-1:2000
Medical gloves for single use – Part 1: Requirements and testing for freedom from holes |
30/09/2005 |
EN 455-1:1993 |
30/04/2001 |
| CEN | EN 455-2:2009+A2:2013
Medical gloves for single use – Part 2: Requirements and testing for physical properties |
16/05/2014 |
EN 455-2:2009+A1:2011 |
31/10/2014 |
| CEN | EN 455-3:2006
Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |
09/08/2007 |
EN 455-3:1999 |
30/06/2007 |
| CEN | EN 455-4:2009
Medical gloves for single use – Part 4: Requirements and testing for shelf life determination |
07/07/2010 |
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| CEN | EN 556-1:2001
Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 1: Requirements for terminally sterilized medical devices |
31/07/2002 |
EN 556:1994 + A1:1998 |
30/04/2002 |
| EN 556-1:2001/AC:2006
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15/11/2006 |
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| CEN | EN 556-2:2015 (new)
Sterilization of medical devices – Requirements for medical devices to be designated »STERILE» – Part 2: Requirements for aseptically processed medical devices |
EN 556-2:2003 |
30/06/2016 |
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| CEN | EN 794-3:1998+A2:2009
Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators |
07/07/2010 |
EN 794-3:1998 |
21/03/2010 |
| CEN | EN 980:2008
Symbols for use in the labelling of medical devices |
23/07/2008 |
EN 980:2003 |
31/05/2010 |
| CEN | EN 1041:2008
Information supplied by the manufacturer of medical devices |
19/02/2009 |
EN 1041:1998 |
31/08/2011 |
| CEN | EN 1060-3:1997+A2:2009
Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
07/07/2010 |
EN 1060-3:1997 |
31/05/2010 |
| CEN | EN 1060-4:2004
Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
30/09/2005 |
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| CEN | EN ISO 1135-4:2011
Transfusion equipment for medical use – Part 4: Transfusion sets for single use (ISO 1135-4:2010) |
27/04/2012 |
EN ISO 1135-4:2010 |
30/04/2012 |
| CEN | EN 1282-2:2005+A1:2009
Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
07/07/2010 |
EN 1282-2:2005 |
21/03/2010 |
| CEN | EN 1422:1997+A1:2009
Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods |
02/12/2009 |
EN 1422:1997 |
21/03/2010 |
| CEN | EN 1618:1997
Catheters other than intravascular catheters – Test methods for common properties |
09/05/1998 |
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| CEN | EN 1639:2009
Dentistry – Medical devices for dentistry – Instruments |
07/07/2010 |
EN 1639:2004 |
30/04/2010 |
| CEN | EN 1640:2009
Dentistry – Medical devices for dentistry – Equipment |
07/07/2010 |
EN 1640:2004 |
30/04/2010 |
| CEN | EN 1641:2009
Dentistry – Medical devices for dentistry – Materials |
07/07/2010 |
EN 1641:2004 |
30/04/2010 |
| CEN | EN 1642:2011
Dentistry – Medical devices for dentistry – Dental implants |
27/04/2012 |
EN 1642:2009 |
30/04/2012 |
| CEN | EN 1707:1996
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Lock fittings |
17/05/1997 |
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| CEN | EN 1782:1998+A1:2009
Tracheal tubes and connectors |
07/07/2010 |
EN 1782:1998 |
21/03/2010 |
| CEN | EN 1789:2007+A1:2010
Medical vehicles and their equipment – Road ambulances |
18/01/2011 |
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| CEN | EN 1820:2005+A1:2009
Anaesthetic reservoir bags (ISO 5362:2000, modified) |
07/07/2010 |
EN 1820:2005 |
21/03/2010 |
| CEN | EN 1865-1:2010+A1:2015(new)
Patient handling equipment used in road ambulances – Part 1: General stretcher systems and patient handling equipment |
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| CEN | EN 1865-2:2010+A1:2015(new)
Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher |
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| CEN | EN 1865-3:2012
Patient handling equipment used in road ambulances – Part 3: Heavy duty stretcher |
30/08/2012 |
EN 1865:1999 |
31/12/2012 |
| CEN | EN 1865-4:2012
Patient handling equipment used in road ambulances – Part 4: Foldable patient transfer chair |
30/08/2012 |
EN 1865:1999 |
31/10/2012 |
| CEN | EN 1865-5:2012
Patient handling equipment used in road ambulances – Part 5: Stretcher support |
30/08/2012 |
EN 1865:1999 |
31/12/2012 |
| CEN | EN 1985:1998
Walking aids – General requirements and test methods |
10/08/1999 |
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| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. | ||||
| CEN | EN ISO 3826-2:2008
Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
19/02/2009 |
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| CEN | EN ISO 3826-3:2007
Plastics collapsible containers for human blood and blood components – Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) |
27/02/2008 |
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| CEN | EN ISO 3826-4:2015 (new)
Plastics collapsible containers for human blood and blood components – Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
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| CEN | EN ISO 4074:2002
Natural latex rubber condoms – Requirements and test methods (ISO 4074:2002) |
31/07/2002 |
EN 600:1996 |
31/08/2005 |
| CEN | EN ISO 4135:2001
Anaesthetic and respiratory equipment – Vocabulary (ISO 4135:2001) |
31/07/2002 |
EN ISO 4135:1996 |
28/02/2002 |
| CEN | EN ISO 5359:2008
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) |
23/07/2008 |
EN 739:1998 |
30/06/2010 |
| EN ISO 5359:2008/A1:2011
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30/08/2012 |
30/06/2012 |
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| CEN | EN ISO 5360:2009
Anaesthetic vaporizers – Agent-specific filling systems (ISO 5360:2006) |
02/12/2009 |
EN ISO 5360:2007 |
21/03/2010 |
| 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) |
02/12/2009 |
EN ISO 5366-1:2004 |
21/03/2010 |
| CEN | EN ISO 5840:2009
Cardiovascular implants – Cardiac valve prostheses (ISO 5840:2005) |
02/12/2009 |
EN ISO 5840:2005 |
21/03/2010 |
| CEN | EN ISO 7197:2009
Neurosurgical implants – Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
02/12/2009 |
EN ISO 7197:2006 |
21/03/2010 |
| CEN | EN ISO 7376:2009
Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation (ISO 7376:2009) |
02/12/2009 |
EN ISO 7376:2009 |
21/03/2010 |
| CEN | EN ISO 7396-1:2007
Medical gas pipeline systems – Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) |
09/08/2007 |
EN 737-3:1998 |
30/04/2009 |
| EN ISO 7396-1:2007/A1:2010
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07/07/2010 |
31/07/2010 |
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| EN ISO 7396-1:2007/A2:2010
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07/07/2010 |
31/08/2010 |
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| CEN | EN ISO 7396-2:2007
Medical gas pipeline systems – Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
09/08/2007 |
EN 737-2:1998 |
30/04/2009 |
| CEN | EN ISO 7886-3:2009
Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) |
07/07/2010 |
EN ISO 7886-3:2005 |
21/03/2010 |
| CEN | EN ISO 7886-4:2009
Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006) |
07/07/2010 |
EN ISO 7886-4:2006 |
21/03/2010 |
| CEN | EN ISO 8185:2009
Respiratory tract humidifiers for medical use – Particular requirements for respiratory humidification systems (ISO 8185:2007) |
02/12/2009 |
EN ISO 8185:2007 |
21/03/2010 |
| CEN | EN ISO 8359:2009
Oxygen concentrators for medical use – Safety requirements (ISO 8359:1996) |
02/12/2009 |
EN ISO 8359:1996 |
21/03/2010 |
| EN ISO 8359:2009/A1:2012
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16/01/2015 |
31/01/2013 |
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| CEN | EN ISO 8835-2:2009
Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
02/12/2009 |
EN ISO 8835-2:2007 |
21/03/2010 |
| CEN | EN ISO 8835-3:2009
Inhalational anaesthesia systems – Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) |
02/12/2009 |
EN ISO 8835-3:2007 |
21/03/2010 |
| EN ISO 8835-3:2009/A1:2010
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13/05/2011 |
30/04/2011 |
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| CEN | EN ISO 8835-4:2009
Inhalational anaesthesia systems – Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
02/12/2009 |
EN ISO 8835-4:2004 |
21/03/2010 |
| CEN | EN ISO 8835-5:2009
Inhalational anaesthesia systems – Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
02/12/2009 |
EN ISO 8835-5:2004 |
21/03/2010 |
| CEN | EN ISO 9170-1:2008
Terminal units for medical gas pipeline systems – Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) |
19/02/2009 |
EN 737-1:1998 |
31/07/2010 |
| CEN | EN ISO 9170-2:2008
Terminal units for medical gas pipeline systems – Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
19/02/2009 |
EN 737-4:1998 |
31/07/2010 |
| CEN | EN ISO 9360-1:2009
Anaesthetic and respiratory equipment – Heat and moisture exchangers (HMEs) for humidifying respired gases in humans – Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
02/12/2009 |
EN ISO 9360-1:2000 |
21/03/2010 |
| CEN | EN ISO 9360-2:2009
Anaesthetic and respiratory equipment – Heat and moisture exchangers (HMEs) for humidifying respired gases in humans – Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) |
02/12/2009 |
EN ISO 9360-2:2002 |
21/03/2010 |
| CEN | EN ISO 9713:2009
Neurosurgical implants – Self-closing intracranial aneurysm clips (ISO 9713:2002) |
02/12/2009 |
EN ISO 9713:2004 |
21/03/2010 |
| CEN | EN ISO 10079-1:2009
Medical suction equipment – Part 1: Electrically powered suction equipment – Safety requirements (ISO 10079-1:1999) |
02/12/2009 |
EN ISO 10079-1:1999 |
21/03/2010 |
| CEN | EN ISO 10079-2:2009
Medical suction equipment – Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
02/12/2009 |
EN ISO 10079-2:1999 |
21/03/2010 |
| CEN | EN ISO 10079-3:2009
Medical suction equipment – Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
02/12/2009 |
EN ISO 10079-3:1999 |
21/03/2010 |
| CEN | EN ISO 10328:2006
Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods (ISO 10328:2006) |
09/08/2007 |
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| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. | ||||
| CEN | EN ISO 10524-1:2006
Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) |
02/06/2006 |
EN 738-1:1997 |
31/10/2008 |
| CEN | EN ISO 10524-2:2006
Pressure regulators for use with medical gases – Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
07/06/2009 |
EN 738-2:1998 |
31/10/2008 |
| CEN | EN ISO 10524-3:2006
Pressure regulators for use with medical gases – Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) |
07/09/2006 |
EN 738-3:1998 |
31/10/2008 |
| CEN | EN ISO 10524-4:2008
Pressure regulators for use with medical gases – Part 4: Low-pressure regulators (ISO 10524-4:2008) |
23/07/2008 |
EN 738-4:1998 |
30/06/2010 |
| CEN | EN ISO 10535:2006
Hoists for the transfer of disabled persons – Requirements and test methods (ISO 10535:2006) |
09/08/2007 |
EN ISO 10535:1998 |
30/06/2007 |
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. | ||||
| CEN | EN ISO 10555-1:2009
Sterile, single-use intravascular catheters – Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004) |
02/12/2009 |
EN ISO 10555-1:1996 |
21/03/2010 |
| CEN | EN ISO 10651-2:2009
Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
02/12/2009 |
EN ISO 10651-2:2004 |
21/03/2010 |
| CEN | EN ISO 10651-4:2009
Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
02/12/2009 |
EN ISO 10651-4:2002 |
21/03/2010 |
| CEN | EN ISO 10651-6:2009
Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
02/12/2009 |
EN ISO 10651-6:2004 |
21/03/2010 |
| CEN | EN ISO 10993-1:2009
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
02/12/2009 |
EN ISO 10993-1:2009 |
21/03/2010 |
| EN ISO 10993-1:2009/AC:2010
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18/01/2011 |
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| CEN | EN ISO 10993-3:2014
Biological 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 |
The date of this publication |
| CEN | EN ISO 10993-4:2009
Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
02/12/2009 |
EN ISO 10993-4:2002 |
21/03/2010 |
| CEN | EN ISO 10993-5:2009
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
02/12/2009 |
EN ISO 10993-5:1999 |
31/12/2009 |
| CEN | EN ISO 10993-6:2009
Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
02/12/2009 |
EN ISO 10993-6:2007 |
21/03/2010 |
| CEN | EN ISO 10993-7:2008
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
19/02/2009 |
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| EN ISO 10993-7:2008/AC:2009
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07/07/2010 |
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| CEN | EN ISO 10993-9:2009
Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
02/12/2009 |
EN ISO 10993-9:2009 |
21/03/2010 |
| CEN | EN ISO 10993-11:2009
Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
02/12/2009 |
EN ISO 10993-11:2006 |
21/03/2010 |
| CEN | EN ISO 10993-12:2012
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
24/01/2013 |
EN ISO 10993-12:2009 |
31/01/2013 |
| CEN | EN ISO 10993-13:2010
Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
18/01/2011 |
EN ISO 10993-13:2009 |
31/12/2010 |
| CEN | EN ISO 10993-14:2009
Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
02/12/2009 |
EN ISO 10993-14:2001 |
21/03/2010 |
| CEN | EN ISO 10993-15:2009
Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
02/12/2009 |
EN ISO 10993-15:2000 |
21/03/2010 |
| CEN | EN ISO 10993-16:2010
Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
07/07/2010 |
EN ISO 10993-16:2009 |
31/08/2010 |
| CEN | EN ISO 10993-17:2009
Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
02/12/2009 |
EN ISO 10993-17:2002 |
21/03/2010 |
| CEN | EN ISO 10993-18:2009
Biological evaluation of medical devices – Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
02/12/2009 |
EN ISO 10993-18:2005 |
21/03/2010 |
| CEN | EN ISO 11135-1:2007
Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
09/08/2007 |
EN 550:1994 |
31/05/2010 |
| CEN | EN ISO 11137-1:2015 (new)
Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
EN ISO 11137-1:2006 |
30/06/2016 |
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| CEN | EN ISO 11137-2:2015 (new)
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
EN ISO 11137-2:2013 |
30/06/2016 |
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| CEN | EN ISO 11138-2:2009
Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
02/12/2009 |
EN ISO 11138-2:2006 |
21/03/2010 |
| CEN | EN ISO 11138-3:2009
Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
02/12/2009 |
EN ISO 11138-3:2006 |
21/03/2010 |
| CEN | EN ISO 11140-1:2009
Sterilization of health care products – Chemical indicators – Part 1: General requirements (ISO 11140-1:2005) |
02/12/2009 |
EN ISO 11140-1:2005 |
21/03/2010 |
| CEN | EN ISO 11140-3:2009
Sterilization of health care products – Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) |
02/12/2009 |
EN ISO 11140-3:2007 |
21/03/2010 |
| CEN | EN ISO 11197:2009
Medical supply units (ISO 11197:2004) |
02/12/2009 |
EN ISO 11197:2004 |
21/03/2010 |
| CEN | EN ISO 11607-1:2009
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
02/12/2009 |
EN ISO 11607-1:2006 |
21/03/2010 |
| CEN | EN ISO 11607-2:2006
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) |
07/09/2006 |
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| CEN | EN ISO 11737-1:2006
Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
07/09/2006 |
EN 1174-1:1996 |
31/10/2006 |
| EN ISO 11737-1:2006/AC:2009
|
02/12/2009 |
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| CEN | EN ISO 11737-2:2009
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
07/07/2010 |
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| CEN | EN ISO 11810-1:2009
Lasers and laser-related equipment – Test method and classification for the laser resistance of surgical drapes and/or patient protective covers – Part 1: Primary ignition and penetration (ISO 11810-1:2005) |
02/12/2009 |
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| CEN | EN ISO 11810-2:2009
Lasers and laser-related equipment – Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers – Part 2: Secondary ignition (ISO 11810-2:2007) |
02/12/2009 |
EN ISO 11810-2:2007 |
21/03/2010 |
| CEN | EN ISO 11979-8:2009
Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements (ISO 11979-8:2006) |
02/12/2009 |
EN ISO 11979-8:2006 |
21/03/2010 |
| CEN | EN ISO 11990-1:2014
Lasers and laser-related equipment – Determination of laser resistance of tracheal tubes – Part 1: Tracheal tube shaft (ISO 11990-1:2011) |
10/07/2015 |
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| CEN | EN ISO 11990-2:2014
Lasers and laser-related equipment – Determination of laser resistance of tracheal tubes – Part 2: Tracheal tube cuffs (ISO 11990-2:2010) |
10/07/2015 |
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| CEN | EN 12006-2:1998+A1:2009
Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 2: Vascular prostheses including cardiac valve conduits |
02/12/2009 |
EN 12006-2:1998 |
21/03/2010 |
| CEN | EN 12006-3:1998+A1:2009
Non active surgical implants – Particular requirements for cardiac and vascular implants – Part 3: Endovascular devices |
02/12/2009 |
EN 12006-3:1998 |
21/03/2010 |
| CEN | EN 12183:2009
Manual wheelchairs – Requirements and test methods |
07/07/2010 |
|
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| CEN | EN 12184:2009
Electrically powered wheelchairs, scooters and their chargers – Requirements and test methods |
07/07/2010 |
|
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| CEN | EN 12342:1998+A1:2009
Breathing tubes intended for use with anaesthetic apparatus and ventilators |
07/07/2010 |
EN 12342:1998 |
21/03/2010 |
| CEN | EN 12470-1:2000+A1:2009
Clinical thermometers – Part 1: Metallic liquid-in-glass thermometers with maximum device |
02/12/2009 |
EN 12470-1:2000 |
21/03/2010 |
| CEN | EN 12470-2:2000+A1:2009
Clinical thermometers – Part 2: Phase change type (dot matrix) thermometers |
02/12/2009 |
EN 12470-2:2000 |
21/03/2010 |
| CEN | EN 12470-3:2000+A1:2009
Clinical thermometers – Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
02/12/2009 |
EN 12470-3:2000 |
21/03/2010 |
| CEN | EN 12470-4:2000+A1:2009
Clinical thermometers – Part 4: Performance of electrical thermometers for continuous measurement |
02/12/2009 |
EN 12470-4:2000 |
21/03/2010 |
| CEN | EN 12470-5:2003
Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device) |
07/11/2003 |
|
|
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. | ||||
| CEN | EN ISO 12870:2009
Ophthalmic optics – Spectacle frames – Requirements and test methods (ISO 12870:2004) |
02/12/2009 |
EN ISO 12870:2004 |
21/03/2010 |
| CEN | EN 13060:2014
Small steam sterilizers |
10/07/2015 |
EN 13060:2004+A2:2010 |
The date of this publication |
| CEN | EN ISO 13408-1:2015 (new)
Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
EN ISO 13408-1:2011 |
30/06/2016 |
|
| CEN | EN ISO 13408-2:2011
Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-3:2011
Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-4:2011
Aseptic processing of health care products – Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-5:2011
Aseptic processing of health care products – Part 5: Sterilization in place (ISO 13408-5:2006) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-6:2011
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-7:2015 (new)
Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
|
|
|
| CEN | EN ISO 13485:2012
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003) |
30/08/2012 |
EN ISO 13485:2003 |
31/08/2012 |
| EN ISO 13485:2012/AC:2012
|
30/08/2012 |
|
|
|
| CEN | EN 13544-1:2007+A1:2009
Respiratory therapy equipment – Part 1: Nebulizing systems and their components |
07/07/2010 |
EN 13544-1:2007 |
21/03/2010 |
| CEN | EN 13544-2:2002+A1:2009
Respiratory therapy equipment – Part 2: Tubing and connectors |
07/07/2010 |
EN 13544-2:2002 |
21/03/2010 |
| CEN | EN 13544-3:2001+A1:2009
Respiratory therapy equipment – Part 3: Air entrainment devices |
07/07/2010 |
EN 13544-3:2001 |
21/03/2010 |
| CEN | EN 13624:2003
Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area – Test method and requirements (phase 2, step 1) |
30/09/2005 |
|
|
| CEN | EN 13718-1:2008
Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances |
19/02/2009 |
EN 13718-1:2002 |
28/02/2009 |
| CEN | EN 13718-2:2015
Medical vehicles and their equipment – Air ambulances – Part 2: Operational and technical requirements for air ambulances |
10/07/2015 |
|
|
| CEN | EN 13726-1:2002
Test methods for primary wound dressings – Part 1: Aspects of absorbency |
27/03/2003 |
|
|
| EN 13726-1:2002/AC:2003
|
02/12/2009 |
|
|
|
| CEN | EN 13726-2:2002
Test methods for primary wound dressings – Part 2: Moisture vapour transmission rate of permeable film dressings |
27/03/2003 |
|
|
| CEN | EN 13727:2012
Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area – Test method and requirements (phase 2, step 1) |
30/08/2012 |
EN 13727:2003 |
30/11/2012 |
| CEN | EN 13867:2002+A1:2009
Concentrates for haemodialysis and related therapies |
02/12/2009 |
EN 13867:2002 |
21/03/2010 |
| CEN | EN 13976-1:2011
Rescue systems – Transportation of incubators – Part 1: Interface conditions |
19/08/2011 |
EN 13976-1:2003 |
30/11/2011 |
| CEN | EN 13976-2:2011
Rescue systems – Transportation of incubators – Part 2: System requirements |
19/08/2011 |
EN 13976-2:2003 |
30/11/2011 |
| CEN | EN 14079:2003
Non-active medical devices – Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
30/09/2005 |
|
|
| CEN | EN 14139:2010
Ophthalmic optics – Specifications for ready-to-wear spectacles |
18/01/2011 |
|
|
| CEN | EN ISO 14155:2011
Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011) |
27/04/2012 |
EN ISO 14155:2011 |
30/04/2012 |
| CEN | EN 14180:2003+A2:2009
Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing |
07/07/2010 |
EN 14180:2003+A1:2009 |
21/03/2010 |
| CEN | EN 14348:2005
Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants – Test methods and requirements (phase 2, step 1) |
30/09/2005 |
|
|
| CEN | EN ISO 14408:2009
Tracheal tubes designed for laser surgery – Requirements for marking and accompanying information (ISO 14408:2005) |
02/12/2009 |
EN ISO 14408:2005 |
21/03/2010 |
| CEN | EN 14561:2006
Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2) |
15/11/2006 |
|
|
| CEN | EN 14562:2006
Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2) |
15/11/2006 |
|
|
| CEN | EN 14563:2008
Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test method and requirements (phase 2, step 2) |
19/02/2009 |
|
|
| CEN | EN ISO 14602:2011
Non-active surgical implants – Implants for osteosynthesis – Particular requirements (ISO 14602:2010) |
27/04/2012 |
EN ISO 14602:2010 |
30/04/2012 |
| CEN | EN ISO 14607:2009
Non-active surgical implants – Mammary implants – Particular requirements (ISO 14607:2007) |
02/12/2009 |
EN ISO 14607:2007 |
21/03/2010 |
| CEN | EN ISO 14630:2009
Non-active surgical implants – General requirements (ISO 14630:2008) |
02/12/2009 |
EN ISO 14630:2008 |
21/03/2010 |
| CEN | EN 14683:2005
Surgical masks – Requirements and test methods |
02/06/2006 |
|
|
| CEN | EN ISO 14889:2009
Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
02/12/2009 |
EN ISO 14889:2003 |
21/03/2010 |
| CEN | EN 14931:2006
Pressure vessels for human occupancy (PVHO) – Multi-place pressure chamber systems for hyperbaric therapy – Performance, safety requirements and testing |
15/11/2006 |
|
|
| CEN | EN ISO 14937:2009
Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
07/07/2010 |
EN ISO 14937:2000 |
30/04/2010 |
| CEN | EN ISO 14971:2012
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
30/08/2012 |
EN ISO 14971:2009 |
30/08/2012 |
| CEN | EN ISO 15001:2011
Anaesthetic and respiratory equipment – Compatibility with oxygen (ISO 15001:2010) |
27/04/2012 |
EN ISO 15001:2010 |
30/04/2012 |
| CEN | EN ISO 15002:2008
Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
19/02/2009 |
EN 13220:1998 |
31/07/2010 |
| CEN | EN ISO 15004-1:2009
Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
02/12/2009 |
EN ISO 15004-1:2006 |
21/03/2010 |
| CEN | EN ISO 15747:2011
Plastic containers for intravenous injections (ISO 15747:2010) |
27/04/2012 |
EN ISO 15747:2010 |
30/04/2012 |
| CEN | EN ISO 15798:2010
Ophthalmic implants – Ophthalmic viscosurgical devices (ISO 15798:2010) |
07/07/2010 |
|
|
| CEN | EN ISO 15883-1:2009
Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
02/12/2009 |
EN ISO 15883-1:2006 |
21/03/2010 |
| CEN | EN ISO 15883-2:2009
Washer-disinfectors – Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) |
02/12/2009 |
EN ISO 15883-2:2006 |
21/03/2010 |
| CEN | EN ISO 15883-3:2009
Washer-disinfectors – Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) |
02/12/2009 |
EN ISO 15883-3:2006 |
21/03/2010 |
| CEN | EN ISO 15883-4:2009
Washer-disinfectors – Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) |
02/12/2009 |
EN ISO 15883-4:2008 |
21/03/2010 |
| CEN | EN 15986:2011
Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates |
13/05/2011 |
|
|
| CEN | EN ISO 16061:2009
Instrumentation for use in association with non-active surgical implants – General requirements (ISO 16061:2008, Corrected version 2009-03-15) |
07/07/2010 |
EN ISO 16061:2008 |
28/02/2010 |
| CEN | EN ISO 16201:2006
Technical aids for disabled persons – Environmental control systems for daily living (ISO 16201:2006) |
19/02/2009 |
|
|
| CEN | EN ISO 17510-1:2009
Sleep apnoea breathing therapy – Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
02/12/2009 |
EN ISO 17510-1:2007 |
21/03/2010 |
| CEN | EN ISO 17510-2:2009
Sleep apnoea breathing therapy – Part 2: Masks and application accessories (ISO 17510-2:2007) |
02/12/2009 |
EN ISO 17510-2:2007 |
21/03/2010 |
| CEN | EN ISO 17664:2004
Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) |
30/09/2005 |
|
|
| CEN | EN ISO 17665-1:2006
Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
15/11/2006 |
EN 554:1994 |
31/08/2009 |
| CEN | EN ISO 18777:2009
Transportable liquid oxygen systems for medical use – Particular requirements (ISO 18777:2005) |
02/12/2009 |
EN ISO 18777:2005 |
21/03/2010 |
| CEN | EN ISO 18778:2009
Respiratory equipment – Infant monitors – Particular requirements (ISO 18778:2005) |
02/12/2009 |
EN ISO 18778:2005 |
21/03/2010 |
| CEN | EN ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures – Particular requirements (ISO 18779:2005) |
30/09/2005 |
|
|
| CEN | EN ISO 19054:2006
Rail systems for supporting medical equipment (ISO 19054:2005) |
07/09/2006 |
EN 12218:1998 |
30/06/2008 |
| CEN | EN 20594-1:1993
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements (ISO 594-1:1986) |
18/11/1995 |
|
|
| EN 20594-1:1993/AC:1996
|
02/12/2009 |
|
|
|
| EN 20594-1:1993/A1:1997
|
10/08/1999 |
31/05/1998 |
||
| CEN | EN ISO 21534:2009
Non-active surgical implants – Joint replacement implants – Particular requirements (ISO 21534:2007) |
02/12/2009 |
EN ISO 21534:2007 |
21/03/2010 |
| CEN | EN ISO 21535:2009
Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2007) |
02/12/2009 |
EN ISO 21535:2007 |
21/03/2010 |
| CEN | EN ISO 21536:2009
Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2007) |
02/12/2009 |
EN ISO 21536:2007 |
21/03/2010 |
| CEN | EN ISO 21649:2009
Needle-free injectors for medical use – Requirements and test methods (ISO 21649:2006) |
07/07/2010 |
EN ISO 21649:2006 |
21/03/2010 |
| CEN | EN ISO 21969:2009
High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
07/07/2010 |
EN ISO 21969:2006 |
31/05/2010 |
| CEN | EN ISO 21987:2009
Ophthalmic optics – Mounted spectacle lenses (ISO 21987:2009) |
07/07/2010 |
|
|
| CEN | EN ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007) |
27/02/2008 |
EN 12442-1:2000 |
30/06/2008 |
| CEN | EN ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) |
27/02/2008 |
EN 12442-2:2000 |
30/06/2008 |
| CEN | EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007) |
27/02/2008 |
EN 12442-3:2000 |
30/06/2008 |
| CEN | EN ISO 22523:2006
External limb prostheses and external orthoses – Requirements and test methods (ISO 22523:2006) |
09/08/2007 |
EN 12523:1999 |
30/04/2007 |
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. | ||||
| CEN | EN ISO 22675:2006
Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2006) |
09/08/2007 |
|
|
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. | ||||
| CEN | EN ISO 23328-1:2008
Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003) |
19/02/2009 |
EN 13328-1:2001 |
30/09/2008 |
| CEN | EN ISO 23328-2:2009
Breathing system filters for anaesthetic and respiratory use – Part 2: Non-filtration aspects (ISO 23328-2:2002) |
02/12/2009 |
EN ISO 23328-2:2008 |
21/03/2010 |
| CEN | EN ISO 23747:2009
Anaesthetic and respiratory equipment – Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) |
02/12/2009 |
EN ISO 23747:2007 |
21/03/2010 |
| CEN | EN ISO 25539-1:2009
Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) |
02/12/2009 |
EN 12006-3:1998+A1:2009 |
21/03/2010 |
| EN ISO 25539-1:2009/AC:2011
|
30/08/2012 |
|
|
|
| CEN | EN ISO 25539-2:2009
Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO 25539-2:2008) |
02/12/2009 |
EN 12006-3:1998+A1:2009 |
21/03/2010 |
| EN ISO 25539-2:2009/AC:2011
|
30/08/2012 |
|
|
|
| CEN | EN ISO 26782:2009
Anaesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) |
07/07/2010 |
|
|
| EN ISO 26782:2009/AC:2009
|
07/07/2010 |
|
|
|
| CEN | EN 27740:1992
Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) |
18/11/1995 |
|
|
| EN 27740:1992/AC:1996
|
02/12/2009 |
|
|
|
| EN 27740:1992/A1:1997
|
10/08/1999 |
31/05/1998 |
||
| CEN | EN ISO 81060-1:2012
Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
30/08/2012 |
EN 1060-1:1995+A2:2009 |
31/05/2015 |
| Cenelec | EN 60118-13:2005
Electroacoustics – Hearing aids — Part 13: Electromagnetic compatibility (EMC) |
19/01/2006 |
EN 60118-13:1997 |
01/02/2008 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60522:1999
Determination of the permanent filtration of X-ray tube assemblies |
14/11/2001 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60580:2000
Medical electrical equipment – Dose area product meters |
13/12/2002 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1:2006
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
27/11/2008 |
EN 60601-1:1990# + A13:1996# + A1:1993# + A2:1995 |
01/06/2012 |
| EN 60601-1:2006/AC:2010
|
18/01/2011 |
|
|
|
| EN 60601-1:2006/A1:2013 IEC 60601-1:2005/A1:2012
|
16/05/2014 |
31/12/2017 |
||
| 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. |
||||
| Cenelec | EN 60601-1-1:2001
Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems |
14/11/2001 |
EN 60601-1-1:1993 |
01/11/2003 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1-2:2007
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests |
27/11/2008 |
EN 60601-1-2:2001 |
01/06/2012 |
| EN 60601-1-2:2007/AC:2010
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1-2:2015 (new)
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests |
EN 60601-1-2:2007 |
31/12/2018 |
|
| 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 |
27/11/2008 |
EN 60601-1-3:1994 |
01/06/2012 |
| EN 60601-1-3:2008/AC:2010
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1-4:1996
Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems |
08/11/1997 |
|
|
| EN 60601-1-4:1996/A1:1999 IEC 60601-1-4:1996/A1:1999
|
08/11/1997 |
01/12/2002 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1-6:2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability |
18/01/2011 |
EN 60601-1-6:2007 |
01/04/2013 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1-8:2007
Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
27/11/2008 |
EN 60601-1-8:2004 |
01/06/2012 |
| EN 60601-1-8:2007/AC:2010
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1-10:2008
Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
27/11/2008 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1-11:2010
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
18/01/2011 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-1:1998
Medical electrical equipment – Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV |
14/11/2001 |
|
|
| EN 60601-2-1:1998/A1:2002 IEC 60601-2-1:1998/A1:2002
|
13/12/2002 |
01/06/2005 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-2:2009
Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
07/07/2010 |
EN 60601-2-2:2007 |
01/04/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-3:1993
Medical electrical equipment – Part 2: Particular requirements for the safety of short-wave therapy equipment |
18/11/1995 |
|
|
| EN 60601-2-3:1993/A1:1998 IEC 60601-2-3:1991/A1:1998
|
18/11/1995 |
01/07/2001 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-4:2003
Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators |
15/10/2003 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-5:2000
Medical electrical equipment – Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment |
13/12/2002 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-8:1997
Medical electrical equipment – Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
14/11/2001 |
|
|
| EN 60601-2-8:1997/A1:1997 IEC 60601-2-8:1987/A1:1997
|
14/11/2001 |
01/07/1998 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-10:2000
Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators |
13/12/2002 |
|
|
| EN 60601-2-10:2000/A1:2001 IEC 60601-2-10:1987/A1:2001
|
13/12/2002 |
01/11/2004 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-11:1997
Medical electrical equipment – Part 2-11: Particular requirements for the safety of gamma beam therapy equipment |
09/10/1999 |
|
|
| EN 60601-2-11:1997/A1:2004 IEC 60601-2-11:1997/A1:2004
|
09/10/1999 |
01/09/2007 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-12:2006
Medical electrical equipment – Part 2-12: Particular requirements for the safety of lung ventilators – Critical care ventilators |
22/12/2007 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-13:2006
Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems |
22/12/2007 |
|
|
| EN 60601-2-13:2006/A1:2007 IEC 60601-2-13:2003/A1:2006
|
22/12/2007 |
01/03/2010 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-16:1998
Medical electrical equipment – Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment |
09/10/1999 |
|
|
| EN 60601-2-16:1998/AC:1999
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-17:2004
Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
08/11/2005 |
EN 60601-2-17:1996 |
01/03/2007 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-18:1996
Medical electrical equipment – Part 2: Particular requirements for the safety of endoscopic equipment |
09/10/1999 |
|
|
| EN 60601-2-18:1996/A1:2000 IEC 60601-2-18:1996/A1:2000
|
09/10/1999 |
01/08/2003 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-19:2009
Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
07/07/2010 |
EN 60601-2-19:1996 |
01/04/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-20:2009
Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
18/01/2011 |
EN 60601-2-20:1996 |
01/09/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-21:2009
Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
07/07/2010 |
EN 60601-2-21:1994 |
01/04/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-22:1996
Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment |
17/05/1997 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-23:2000
Medical electrical equipment – Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment |
14/11/2001 |
EN 60601-2-23:1997 |
01/01/2003 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-24:1998
Medical electrical equipment – Part 2-24: Particular requirements for the safety of infusion pumps and controllers |
09/10/1999 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-25:1995
Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs |
17/05/1997 |
|
|
| EN 60601-2-25:1995/A1:1999 IEC 60601-2-25:1993/A1:1999
|
13/12/2002 |
01/05/2002 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-26:2003
Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs |
08/11/2005 |
EN 60601-2-26:1994 |
01/03/2006 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-27:2006
Medical electrical equipment – Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment |
26/07/2006 |
EN 60601-2-27:1994 |
01/11/2008 |
| EN 60601-2-27:2006/AC:2006
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-28:2010
Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
18/01/2011 |
EN 60601-2-28:1993 |
01/04/2013 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-29:2008
Medical electrical equipment – Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
15/07/2009 |
EN 60601-2-29:1999 |
01/11/2011 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-30:2000
Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
14/11/2001 |
EN 60601-2-30:1995 |
01/02/2003 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-33:2002
Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis |
15/10/2003 |
EN 60601-2-33:1995 |
01/07/2005 |
| EN 60601-2-33:2002/A1:2005 IEC 60601-2-33:2002/A1:2005
|
27/07/2006 |
01/11/2008 |
||
| EN 60601-2-33:2002/A2:2008 IEC 60601-2-33:2002/A2:2007
|
27/11/2008 |
01/02/2011 |
||
| EN 60601-2-33:2002/A2:2008/AC:2008
|
30/08/2012 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-34:2000
Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment |
15/10/2003 |
EN 60601-2-34:1995 |
01/11/2003 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-36:1997
Medical electrical equipment – Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
09/10/1999 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-37:2008
Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
27/11/2008 |
EN 60601-2-37:2001 |
01/10/2010 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-39:2008
Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
27/11/2008 |
EN 60601-2-39:1999 |
01/03/2011 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-40:1998
Medical electrical equipment – Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment |
09/10/1999 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-41:2009
Medical electrical equipment – Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
18/01/2011 |
EN 60601-2-41:2000 |
01/11/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-43:2010
Medical electrical equipment – Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures |
18/01/2011 |
EN 60601-2-43:2000 |
01/06/2013 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-44:2009
Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
07/07/2010 |
EN 60601-2-44:2001 |
01/05/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-45:2001
Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices |
14/11/2001 |
EN 60601-2-45:1998 |
01/07/2004 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-46:1998
Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables |
14/11/2001 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-47:2001
Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems |
13/12/2002 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-49:2001
Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment |
13/12/2002 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-50:2009
Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
07/07/2010 |
EN 60601-2-50:2002 |
01/05/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-51:2003
Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
24/06/2004 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-2-52:2010
Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009) |
13/05/2011 |
EN 1970:2000# + A1:2005 |
01/06/2012 |
| 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. | ||||
| Cenelec | EN 60601-2-54:2009
Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
18/01/2011 |
EN 60601-2-7:1998 |
01/08/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60627:2001
Diagnostic X-ray imaging equipment – Characteristics of general purpose and mammographic anti-scatter grids |
13/12/2002 |
|
|
| EN 60627:2001/AC:2002
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60645-1:2001
Electroacoustics – Audiological equipment – Part 1: Pure-tone audiometers |
13/12/2002 |
EN 60645-1:1994 |
01/10/2004 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60645-2:1997
Audiometers – Part 2: Equipment for speech audiometry |
17/05/1997 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60645-3:2007
Electroacoustics – Audiometric equipment – Part 3: Test signals of short duration |
27/11/2008 |
EN 60645-3:1995 |
01/06/2010 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60645-4:1995
Audiometers – Part 4: Equipment for extended high-frequency audiometry |
23/08/1996 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 61217:2012
Radiotherapy equipment – Coordinates, movements and scales |
30/08/2012 |
EN 61217:1996 |
11/01/2015 |
| Cenelec | EN 61676:2002
Medical electrical equipment – Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology |
15/10/2003 |
|
|
| EN 61676:2002/A1:2009 IEC 61676:2002/A1:2008
|
07/07/2010 |
01/03/2012 |
||
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 62083:2009
Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems |
18/01/2011 |
EN 62083:2001 |
01/11/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 62220-1:2004
Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1: Determination of the detective quantum efficiency |
24/06/2004 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 62220-1-2:2007
Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-2: Determination of the detective quantum efficiency – Detectors used in mammography |
27/11/2008 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 62220-1-3:2008
Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-3: Determination of the detective quantum efficiency – Detectors used in dynamic imaging |
15/07/2009 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 62304:2006
Medical device software – Software life-cycle processes |
27/11/2008 |
|
|
| EN 62304:2006/AC:2008
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 62366:2008
Medical devices – Application of usability engineering to medical devices |
27/11/2008 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 80601-2-35:2009
Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
18/01/2011 |
EN 60601-2-35:1996 |
01/11/2012 |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 80601-2-58:2009
Medical electrical equipment – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
07/07/2010 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 80601-2-59:2009
Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
18/01/2011 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
(1) ESO: European standardisation organisation:
CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)
Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.
Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.
Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Normativa armonizada Directiva IVD
|
ESO(1) |
Reference and title of the standard |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard |
| CEN | EN 556-1:2001
Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 1: Requirements for terminally sterilized medical devices |
31/07/2002 |
EN 556:1994 + A1:1998 |
30/04/2002 |
| EN 556-1:2001/AC:2006
|
15/11/2006 |
|
|
|
| CEN | EN 556-2:2015
Sterilization of medical devices – Requirements for medical devices to be designated »STERILE» – Part 2: Requirements for aseptically processed medical devices |
13/05/2016 |
EN 556-2:2003 |
30/06/2016 |
| CEN | EN 980:2008
Symbols for use in the labelling of medical devices |
23/07/2008 |
|
31/05/2010 |
| CEN | EN ISO 11137-2:2015 (new)
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
|
30/06/2016 |
|
| CEN | EN ISO 11737-2:2009
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
07/07/2010 |
|
|
| CEN | EN 12322:1999
In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media |
09/10/1999 |
|
|
| EN 12322:1999/A1:2001
|
31/07/2002 |
30/04/2002 |
||
| CEN | EN ISO 13408-2:2011
Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003) |
19/08/2011 |
|
|
| CEN | EN ISO 13408-3:2011
Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006) |
19/08/2011 |
|
|
| CEN | EN ISO 13408-4:2011
Aseptic processing of health care products – Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
19/08/2011 |
|
|
| CEN | EN ISO 13408-5:2011
Aseptic processing of health care products – Part 5: Sterilization in place (ISO 13408-5:2006) |
19/08/2011 |
|
|
| CEN | EN ISO 13408-6:2011
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005) |
19/08/2011 |
|
|
| CEN | EN ISO 13408-7:2015 (new)
Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
|
|
|
| CEN | EN ISO 13485:2012
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003) |
30/08/2012 |
|
31/08/2012 |
| CEN | EN 13532:2002
General requirements for in vitro diagnostic medical devices for self-testing |
17/12/2002 |
|
|
| CEN | EN 13612:2002
Performance evaluation of in vitro diagnostic medical devices |
17/12/2002 |
|
|
| EN 13612:2002/AC:2002
|
02/12/2009 |
|
|
|
| CEN | EN 13641:2002
Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
17/12/2002 |
|
|
| CEN | EN 13975:2003
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices – Statistical aspects |
21/11/2003 |
|
|
| CEN | EN 14136:2004
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
15/11/2006 |
|
|
| CEN | EN 14254:2004
In vitro diagnostic medical devices – Single-use receptacles for the collection of specimens, other than blood, from humans |
28/04/2005 |
|
|
| CEN | EN 14820:2004
Single-use containers for human venous blood specimen collection |
28/04/2005 |
|
|
| CEN | EN ISO 14937:2009
Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
07/07/2010 |
EN ISO 14937:2000 |
30/04/2010 |
| CEN | EN ISO 14971:2012
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
30/08/2012 |
EN ISO 14971:2009 |
30/08/2012 |
| CEN | EN ISO 15193:2009
In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for content and presentation of reference measurement procedures (ISO 15193:2009) |
07/07/2010 |
|
|
| CEN | EN ISO 15194:2009
In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) |
07/07/2010 |
|
|
| CEN | EN ISO 15197:2015
In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
13/05/2016 |
EN ISO 15197:2003 |
31/07/2016 |
| For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30/06/2017. | ||||
| CEN | EN ISO 17511:2003
In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
28/04/2005 |
|
|
| CEN | EN ISO 18113-1:2011
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
27/04/2012 |
EN ISO 18113-1:2009 |
30/04/2012 |
| CEN | EN ISO 18113-2:2011
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
27/04/2012 |
EN ISO 18113-2:2009 |
30/04/2012 |
| CEN | EN ISO 18113-3:2011
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
27/04/2012 |
EN ISO 18113-3:2009 |
30/04/2012 |
| CEN | EN ISO 18113-4:2011
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
27/04/2012 |
EN ISO 18113-4:2009 |
30/04/2012 |
| CEN | EN ISO 18113-5:2011
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
27/04/2012 |
EN ISO 18113-5:2009 |
30/04/2012 |
| CEN | EN ISO 18153:2003
In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) |
21/11/2003 |
|
|
| CEN | EN ISO 20776-1:2006
Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006) |
09/08/2007 |
|
|
| CEN | EN ISO 23640:2015
In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
13/05/2016 |
EN ISO 13640:2002 |
30/06/2017 |
| Cenelec | EN 61010-2-101:2002
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
17/12/2002 |
|
|
| Cenelec | EN 61326-2-6:2006
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment |
27/11/2008 |
|
|
| Cenelec | EN 62304:2006
Medical device software – Software life-cycle processes |
27/11/2008 |
|
|
| Cenelec | EN 62366:2008
Medical devices – Application of usability engineering to medical devices |
27/11/2008 |
|
|
(1) ESO: European standardisation organisation:
CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)
Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.
Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.
Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Normativa armonizada Implantables Activos
|
ESO(1) |
Reference and title of the standard |
First publication OJ |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard |
| CEN | EN 556-1:2001
Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 1: Requirements for terminally sterilized medical devices |
31/07/2002 |
EN 556:1994 + A1:1998 |
30/04/2002 |
| EN 556-1:2001/AC:2006
|
15/11/2006 |
|
|
|
| CEN | EN 556-2:2015 (new)
Sterilization of medical devices – Requirements for medical devices to be designated »STERILE» – Part 2: Requirements for aseptically processed medical devices |
EN 556-2:2003 |
30/06/2016 |
|
| CEN | EN 980:2008
Symbols for use in the labelling of medical devices |
23/07/2008 |
EN 980:2003 |
31/05/2010 |
| CEN | EN 1041:2008
Information supplied by the manufacturer of medical devices |
19/02/2009 |
EN 1041:1998 |
31/08/2011 |
| CEN | EN ISO 10993-1:2009
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
02/12/2009 |
EN ISO 10993-1:2009 |
21/03/2010 |
| EN ISO 10993-1:2009/AC:2010
|
18/01/2011 |
|
|
|
| CEN | EN ISO 10993-3:2014
Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
10/07/2015 |
|
|
| CEN | EN ISO 10993-4:2009
Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
02/12/2009 |
EN ISO 10993-4:2002 |
21/03/2010 |
| CEN | EN ISO 10993-5:2009
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
02/12/2009 |
EN ISO 10993-5:1999 |
31/12/2009 |
| CEN | EN ISO 10993-6:2009
Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
02/12/2009 |
EN ISO 10993-6:2007 |
21/03/2010 |
| CEN | EN ISO 10993-7:2008
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
07/07/2010 |
|
|
| EN ISO 10993-7:2008/AC:2009
|
07/07/2010 |
|
|
|
| CEN | EN ISO 10993-9:2009
Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
02/12/2009 |
EN ISO 10993-9:2009 |
21/03/2010 |
| CEN | EN ISO 10993-11:2009
Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
02/12/2009 |
EN ISO 10993-11:2006 |
21/03/2010 |
| CEN | EN ISO 10993-12:2012
Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
24/01/2013 |
EN ISO 10993-12:2009 |
31/01/2013 |
| CEN | EN ISO 10993-13:2010
Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
18/01/2011 |
EN ISO 10993-13:2009 |
31/12/2010 |
| CEN | EN ISO 10993-16:2010
Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
07/07/2010 |
EN ISO 10993-16:2009 |
31/08/2010 |
| CEN | EN ISO 10993-17:2009
Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
02/12/2009 |
EN ISO 10993-17:2002 |
21/03/2010 |
| CEN | EN ISO 10993-18:2009
Biological evaluation of medical devices – Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
02/12/2009 |
EN ISO 10993-18:2005 |
21/03/2010 |
| CEN | EN ISO 11135-1:2007
Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
09/08/2007 |
EN 550:1994 |
31/05/2010 |
| CEN | EN ISO 11137-1:2015 (new)
Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
EN ISO 11137-1:2006 |
30/06/2016 |
|
| CEN | EN ISO 11137-2:2015 (new)
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
EN ISO 11137-2:2013 |
30/06/2016 |
|
| CEN | EN ISO 11138-2:2009
Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
02/12/2009 |
EN ISO 11138-2:2006 |
21/03/2010 |
| CEN | EN ISO 11138-3:2009
Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
02/12/2009 |
EN ISO 11138-3:2006 |
21/03/2010 |
| CEN | EN ISO 11140-1:2009
Sterilization of health care products – Chemical indicators – Part 1: General requirements (ISO 11140-1:2005) |
02/12/2009 |
EN ISO 11140-1:2005 |
21/03/2010 |
| CEN | EN ISO 11607-1:2009
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
02/12/2009 |
EN ISO 11607-1:2006 |
21/03/2010 |
| CEN | EN ISO 11737-1:2006
Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
07/09/2006 |
EN 1174-1:1996 |
31/10/2006 |
| EN ISO 11737-1:2006/AC:2009
|
02/12/2009 |
|
|
|
| CEN | EN ISO 11737-2:2009
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
07/07/2010 |
|
|
| CEN | EN ISO 13408-1:2015 (new)
Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
EN ISO 13408-1:2011 |
30/06/2016 |
|
| CEN | EN ISO 13408-2:2011
Aseptic processing of health care products – Part 2: Filtration (ISO 13408-2:2003) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-3:2011
Aseptic processing of health care products – Part 3: Lyophilization (ISO 13408-3:2006) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-4:2011
Aseptic processing of health care products – Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-5:2011
Aseptic processing of health care products – Part 5: Sterilization in place (ISO 13408-5:2006) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-6:2011
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2005) |
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
| CEN | EN ISO 13408-7:2015 (new)
Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
|
|
|
| CEN | EN ISO 13485:2012
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003) |
30/08/2012 |
EN ISO 13485:2003 |
30/08/2012 |
| EN ISO 13485:2012/AC:2012
|
30/08/2012 |
|
|
|
| CEN | EN ISO 14155:2011
Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011) |
27/04/2012 |
EN ISO 14155:2011 |
30/04/2012 |
| CEN | EN ISO 14937:2009
Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
07/07/2010 |
EN ISO 14937:2000 |
21/03/2010 |
| CEN | EN ISO 14971:2012
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
30/08/2012 |
EN ISO 14971:2009 |
30/08/2012 |
| CEN | EN ISO 17665-1:2006
Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
15/11/2006 |
EN 554:1994 |
31/08/2009 |
| Cenelec | EN 45502-1:1997
Active implantable medical devices – Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
27/08/1998 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 45502-2-1:2003
Active implantable medical devices – Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) |
08/07/2004 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 45502-2-2:2008
Active implantable medical devices – Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
27/11/2008 |
|
|
| EN 45502-2-2:2008/AC:2009
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 45502-2-3:2010
Active implantable medical devices – Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
18/01/2011 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 60601-1:2006
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
27/11/2008 |
EN 60601-1:1990 |
01/06/2012 |
| EN 60601-1:2006/AC:2010
|
18/01/2011 |
|
|
|
| EN 60601-1:2006/A1:2013 IEC 60601-1:2005/A1:2012
|
10/07/2015 |
31/12/2017 |
||
| 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 90/385/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 90/385/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013. |
||||
| Cenelec | EN 60601-1-6:2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability |
18/01/2011 |
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
| Cenelec | EN 62304:2006
Medical device software – Software life-cycle processes |
27/11/2008 |
|
|
| EN 62304:2006/AC:2008
|
18/01/2011 |
|
|
|
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. | ||||
(1) ESO: European standardisation organisation:
CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)
Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.
Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.
Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.