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Medical devices 医疗器械指令
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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Summary list of titles and references harmonised standards under Directive 93/42/EEC for Medical devices |
The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.
Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal effect.
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
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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Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard |
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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 |
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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 |
This is the first publication |
EN 556-2:2003 |
30/06/2016 |
|
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 |
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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 |
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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 |
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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 |
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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 |
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CEN |
EN 1865-1:2010+A1:2015 (new) Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
This is the first publication |
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CEN |
EN 1865-2:2010+A1:2015 (new) Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
This is the first publication |
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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 |
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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 |
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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 |
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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. |
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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) |
This is the first publication |
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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 |
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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 |
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EN ISO 5359:2008/A1:2011
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30/08/2012 |
Note 3 |
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 |
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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 |
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CEN |
EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
02/12/2009 |
EN ISO 5840:2005 |
21/03/2010 |
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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 |
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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 |
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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 |
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EN ISO 7396-1:2007/A1:2010
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07/07/2010 |
Note 3 |
31/07/2010 |
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EN ISO 7396-1:2007/A2:2010
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07/07/2010 |
Note 3 |
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 |
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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 |
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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 |
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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 |
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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 |
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EN ISO 8359:2009/A1:2012
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16/01/2015 |
Note 3 |
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 |
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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 |
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EN ISO 8835-3:2009/A1:2010
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13/05/2011 |
Note 3 |
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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. |
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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 |
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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 |
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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 |
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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. |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
This is the first publication |
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) |
This is the first publication |
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 |
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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 |
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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 |
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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 |
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CEN |
EN ISO 11197:2009 Medical supply units (ISO 11197:2004) |
02/12/2009 |
EN ISO 11197:2004 |
21/03/2010 |
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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 |
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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 |
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EN ISO 11737-1:2006/AC:2009
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
This is the first publication |
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) |
This is the first publication |
|
|
|
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/A1:1997
|
10/08/1999 |
Note 3 |
31/05/1998 |
|
|
EN 20594-1:1993/AC:1996
|
02/12/2009 |
|
|
|
|
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/A1:1997
|
10/08/1999 |
Note 3 |
31/05/1998 |
|
|
EN 27740:1992/AC:1996
|
02/12/2009 |
|
|
|
|
CEN |
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
30/08/2012 |
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
|
16/05/2014 |
Note 3 |
31/12/2017 |
|
|
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. |
||||
|
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 |
This is the first publication |
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
|
08/11/1997 |
Note 3 |
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
|
13/12/2002 |
Note 3 |
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
|
18/11/1995 |
Note 3 |
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
|
14/11/2001 |
Note 3 |
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
|
13/12/2002 |
Note 3 |
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
|
09/10/1999 |
Note 3 |
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
|
22/12/2007 |
Note 3 |
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 |
|
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|
|
(*): 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
|
09/10/1999 |
Note 3 |
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
|
13/12/2002 |
Note 3 |
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
|
27/07/2006 |
Note 3 |
01/11/2008 |
|
|
EN 60601-2-33:2002/A2:2008
|
27/11/2008 |
Note 3 |
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
|
07/07/2010 |
Note 3 |
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. |
||||
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