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European standards

Medical devices

Directive 93/42/EEC

Short name:

Medical devices

Base:

Council Directive 93/42/EECof 14 June 1993 concerning medical devices
OJ L 169 of 12 July 1993

Modification:

  • Directive 93/68/EEC [CE Marking]
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
  • Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
  • Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices
  • Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directive repealed:

76/764/EEC (repealed as from 1 January 1995)

Guide for application:

EC contact point:

Directorate General for Health and Consumers 
DG SANCO - Cosmetics and Medical Devices, Tel +32 2 2995820
E-mail
Website on medical devices

For information about the content and availability of European standards, please contact the European Standardisation Organisations.

Publications in the Official Journal:

  • Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - OJ C 022 of 24/01/2013
    BG CS DA DE EL EN ES ET FI FR HU IT LT LV MT NL PL PT RO SK SL SV PDF Format
    (This list replaces all the previous lists published in the Official Journal.)


  • Stay up to date with the references of harmonised standards for this Directive, published in the Offical Journal by subcribing to the RSS feed  RSS

    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 affect.

     

    ESO (1)

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

    First publication OJ

    Reference of superseded standard

    Date of cessation of presumption of conformity of superseded standard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

    CEN

    EN 285:2006+A2:2009

    Sterilization - Steam sterilizers - Large sterilizers

    02/12/2009 

    EN 285:2006+A1:2008

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (30/04/2001) 

    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

    Note 2.1 

    Date expired
    (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 

     

     

    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

    Note 2.1 

    Date expired
    (30/04/2002) 

    EN 556-1:2001/AC:2006

    15/11/2006 

     

     

    CEN

    EN 556-2:2003

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

    09/08/2007 

     

     

    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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 1041:2008

    Information supplied by the manufacturer of medical devices

    19/02/2009 

    EN 1041:1998

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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 

     

     

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 1618:1997

    Catheters other than intravascular catheters - Test methods for common properties

    09/05/1998 

     

     

    CEN

    EN 1639:2009

    Dentistry - Medical devices for dentistry - Instruments

    07/07/2010 

    EN 1639:2004

    Note 2.1 

    Date expired
    (30/04/2010) 

    CEN

    EN 1640:2009

    Dentistry - Medical devices for dentistry - Equipment

    07/07/2010 

    EN 1640:2004

    Note 2.1 

    Date expired
    (30/04/2010) 

    CEN

    EN 1641:2009

    Dentistry - Medical devices for dentistry - Materials

    07/07/2010 

    EN 1641:2004

    Note 2.1 

    Date expired
    (30/04/2010) 

    CEN

    EN 1642:2011

    Dentistry - Medical devices for dentistry - Dental implants

    27/04/2012 

    EN 1642:2009

    Note 2.1 

    Date expired
    (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 

     

     

    CEN

    EN 1782:1998+A1:2009

    Tracheal tubes and connectors

    07/07/2010 

    EN 1782:1998

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 1789:2007+A1:2010

    Medical vehicles and their equipment - Road ambulances

    18/01/2011 

     

     

    CEN

    EN 1820:2005+A1:2009

    Anaesthetic reservoir bags (ISO 5362:2000, modified)

    07/07/2010 

    EN 1820:2005

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 1865-3:2012

    Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

    30/08/2012 

    EN 1865:1999

    Note 2.1 

    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

    Note 2.1 

    Date expired
    (31/10/2012) 

    CEN

    EN 1865-5:2012

    Patient handling equipment used in road ambulances - Part 5: Stretcher support

    30/08/2012 

    EN 1865:1999

    Note 2.1 

    31/12/2012 

    CEN

    EN 1985:1998

    Walking aids - General requirements and test methods

    10/08/1999 

     

     

    This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

    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 

     

     

    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 

     

     

    CEN

    EN ISO 4074:2002

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

    31/07/2002 

    EN 600:1996

    Note 2.1 

    Date expired
    (31/08/2005) 

    EN ISO 4074:2002/AC:2008

    02/12/2009 

     

     

    CEN

    EN ISO 4135:2001

    Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)

    31/07/2002 

    EN ISO 4135:1996

    Note 2.1 

    Date expired
    (28/02/2002) 

    CEN

    EN ISO 5356-1:2004

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

    30/09/2005 

    EN 1281-1:1997

    Note 2.1 

    Date expired
    (30/11/2004) 

    CEN

    EN ISO 5356-2:2007

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

    09/11/2007 

    EN 1281-2:1995

    Note 2.1 

    Date expired
    (29/02/2008) 

    CEN

    EN ISO 5359:2008

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

    23/07/2008 

    EN 739:1998

    Note 2.1 

    Date expired
    (30/06/2010) 

    EN ISO 5359:2008/A1:2011

    30/08/2012 

    Note 3 

    Date expired
    (30/06/2012) 

    CEN

    EN ISO 5360:2009

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

    02/12/2009 

    EN ISO 5360:2007

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN ISO 5840:2009

    Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

    02/12/2009 

    EN ISO 5840:2005

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (30/04/2009) 

    EN ISO 7396-1:2007/A1:2010

    07/07/2010 

    Note 3 

    Date expired
    (31/07/2010) 

    EN ISO 7396-1:2007/A2:2010

    07/07/2010 

    Note 3 

    Date expired
    (31/08/2010) 

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    EN ISO 8835-3:2009/A1:2010

    13/05/2011 

    Note 3 

    Date expired
    (30/04/2011) 

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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 

     

     

    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

    Note 2.1 

    Date expired
    (31/10/2008) 

    CEN

    EN ISO 10524-2:2006

    Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

    07/06/2009 

    EN 738-2:1998

    Note 2.1 

    Date expired
    (31/10/2008) 

    CEN

    EN ISO 10524-3:2006

    Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

    07/09/2006 

    EN 738-3:1998

    Note 2.1 

    Date expired
    (31/10/2008) 

    CEN

    EN ISO 10524-4:2008

    Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

    23/07/2008 

    EN 738-4:1998

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    EN ISO 10993-1:2009/AC:2010

    18/01/2011 

     

     

    CEN

    EN ISO 10993-3:2009

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

    02/12/2009 

    EN ISO 10993-3:2003

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN ISO 10993-4:2009

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

    02/12/2009 

    EN ISO 10993-4:2002

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (31/12/2009) 

    CEN

    EN ISO 10993-6:2009

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

    02/12/2009 

    EN ISO 10993-6:2007

    Note 2.1 

    Date expired
    (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 

     

     

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN ISO 10993-12:2012 (new)

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

    This is the first publication 

    EN ISO 10993-12:2009

    Note 2.1 

    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

    Note 2.1 

    Date expired
    (31/12/2010) 

    CEN

    EN ISO 10993-14:2009

    Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

    02/12/2009 

    EN ISO 10993-14:2001

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (31/05/2010) 

    CEN

    EN ISO 11137-1:2006

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)

    07/09/2006 

    EN 552:1994

    Note 2.1 

    Date expired
    (30/04/2009) 

    CEN

    EN ISO 11137-2:2012

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

    30/08/2012 

    EN ISO 11137-2:2007

    Note 2.1 

    Date expired
    (30/09/2012) 

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN ISO 11197:2009

    Medical supply units (ISO 11197:2004)

    02/12/2009 

    EN ISO 11197:2004

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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 

     

     

    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 1174-2:1996
    EN 1174-1:1996
    EN 1174-3:1996


    Note 2.1 

    Date expired
    (31/10/2006) 

    EN ISO 11737-1:2006/AC:2009

    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 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 

     

     

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 12006-2:1998+A1:2009

    Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

    02/12/2009 

    EN 12006-2:1998

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 12183:2009

    Manual wheelchairs - Requirements and test methods

    07/07/2010 

     

     

    CEN

    EN 12184:2009

    Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods

    07/07/2010 

     

     

    CEN

    EN 12342:1998+A1:2009

    Breathing tubes intended for use with anaesthetic apparatus and ventilators

    07/07/2010 

    EN 12342:1998

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 13060:2004+A2:2010

    Small steam sterilizers

    07/07/2010 

    EN 13060:2004+A1:2009

    Note 2.1 

    Date expired
    (30/09/2010) 

    CEN

    EN ISO 13408-1:2011

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

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    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

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-3:2011

    Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-4:2011

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-5:2011

    Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-6:2011

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13485:2012

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

    30/08/2012 

    EN ISO 13485:2003

    Note 2.1 

    The date of this publication
    () 

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (28/02/2009) 

    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

    Note 2.1 

    Date expired
    (30/11/2012) 

    CEN

    EN 13867:2002+A1:2009

    Concentrates for haemodialysis and related therapies

    02/12/2009 

    EN 13867:2002

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN 13976-1:2011

    Rescue systems - Transportation of incubators - Part 1: Interface conditions

    19/08/2011 

    EN 13976-1:2003

    Note 2.1 

    Date expired
    (30/11/2011) 

    CEN

    EN 13976-2:2011

    Rescue systems - Transportation of incubators - Part 2: System requirements

    19/08/2011 

    EN 13976-2:2003

    Note 2.1 

    Date expired
    (30/11/2011) 

    CEN

    EN 14079:2003

    Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

    30/09/2005 

     

     

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN ISO 14630:2009

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

    02/12/2009 

    EN ISO 14630:2008

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN ISO 15747:2011

    Plastic containers for intravenous injections (ISO 15747:2010)

    27/04/2012 

    EN ISO 15747:2010

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (21/03/2010) 

    CEN

    EN ISO 18778:2009

    Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

    02/12/2009 

    EN ISO 18778:2005

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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 

    Date expired
    (31/05/1998) 

    EN 20594-1:1993/AC:1996

    02/12/2009 

     

     

    CEN

    EN ISO 21171:2006

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

    07/09/2006 

     

     

    CEN

    EN ISO 21534:2009

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

    02/12/2009 

    EN ISO 21534:2007

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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 22610:2006

    Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)

    15/11/2006 

     

     

    CEN

    EN ISO 22612:2005

    Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)

    30/09/2005 

     

     

    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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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

    Note 2.1 

    Date expired
    (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 ISO 25539-1:2008
    EN 12006-3:1998+A1:2009


    Note 2.1 

    Date expired
    (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 ISO 25539-2:2008
    EN 12006-3:1998+A1:2009


    Note 2.1 

    Date expired
    (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 

    Date expired
    (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 1060-2:1995+A1:2009
    EN 1060-1:1995+A2:2009


    Note 2.1 

    31/05/2015 

    Cenelec

    EN 60118-13:2005

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

    19/01/2006 

    EN 60118-13:1997

    Note 2.1 

    Date expired
    (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
    IEC 60522:1999

    14/11/2001 

     

     

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

    Cenelec

    EN 60580:2000

    Medical electrical equipment - Dose area product meters
    IEC 60580:2000

    13/12/2002 

     

     

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

    Cenelec

    EN 60601-1:2006

    Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005

    27/11/2008 

    EN 60601-1:1990
    + A1:1993
    + A2:1995
    + A13:1996
    + EN 60601-1-1:2001
    + EN 60601-1-4:1996
    + A1:1999

    Note 2.1 

    Date expired
    (01/06/2012) 

    EN 60601-1:2006/AC:2010

    18/01/2011 

     

     

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

    Cenelec

    EN 60601-1-2:2007

    Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
    IEC 60601-1-2:2007 (Modified)

    27/11/2008 

    EN 60601-1-2:2001
    + A1:2006

    Note 2.1 

    Date expired
    (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 60601-1-3:2008

    Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    IEC 60601-1-3:2008

    27/11/2008 

    EN 60601-1-3:1994

    Note 2.1 

    Date expired
    (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 60601-1-6:2007

    Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
    IEC 60601-1-6:2006

    27/11/2008 

    EN 60601-1-6:2004

    Note 2.1 

    Date expired
    (01/06/2012) 

    EN 60601-1-6:2007/AC:2010

    18/01/2011 

     

     

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

    Cenelec

    EN 60601-1-6:2010

    Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60601-1-6:2010

    18/01/2011 

    EN 60601-1-6:2007

    Note 2.1 

    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
    IEC 60601-1-8:2006

    27/11/2008 

    EN 60601-1-8:2004
    + A1:2006

    Note 2.1 

    Date expired
    (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
    IEC 60601-1-10:2007

    27/11/2008 

     

     

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

    Cenelec

    EN 60601-1-11:2010

    Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    IEC 60601-1-11:2010

    18/01/2011 

     

     

    (*): 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
    IEC 60601-2-1:1998

    14/11/2001 

     

     

    EN 60601-2-1:1998/A1:2002
    IEC 60601-2-1:1998/A1:2002

    13/12/2002 

    Note 3 

    Date expired
    (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
    IEC 60601-2-2:2009

    07/07/2010 

    EN 60601-2-2:2007

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-3:1991

    18/11/1995 

     

     

    EN 60601-2-3:1993/A1:1998
    IEC 60601-2-3:1991/A1:1998

    18/11/1995 

    Note 3 

    Date expired
    (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
    IEC 60601-2-4:2002

    15/10/2003 

     

     

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

    Cenelec

    EN 60601-2-5:2000

    Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
    IEC 60601-2-5:2000

    13/12/2002 

     

     

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

    Cenelec

    EN 60601-2-8:1997

    Medical electrical equipment -- Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
    IEC 60601-2-8:1987

    14/11/2001 

     

     

    EN 60601-2-8:1997/A1:1997
    IEC 60601-2-8:1987/A1:1997

    14/11/2001 

    Note 3 

    Date expired
    (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
    IEC 60601-2-10:1987

    13/12/2002 

     

     

    EN 60601-2-10:2000/A1:2001
    IEC 60601-2-10:1987/A1:2001

    13/12/2002 

    Note 3 

    Date expired
    (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
    IEC 60601-2-11:1997

    09/10/1999 

     

     

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

    09/10/1999 

    Note 3 

    Date expired
    (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
    IEC 60601-2-12:2001

    22/12/2007 

     

     

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

    Cenelec

    EN 60601-2-13:2006

    Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
    IEC 60601-2-13:2003

    22/12/2007 

     

     

    EN 60601-2-13:2006/A1:2007
    IEC 60601-2-13:2003/A1:2006

    22/12/2007 

    Note 3 

    Date expired
    (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
    IEC 60601-2-16:1998

    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
    IEC 60601-2-17:2004

    08/11/2005 

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

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-18:1996

    09/10/1999 

     

     

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

    09/10/1999 

    Note 3 

    Date expired
    (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
    IEC 60601-2-19:2009

    07/07/2010 

    EN 60601-2-19:1996
    + A1:1996 

    Date expired
    (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
    IEC 60601-2-20:2009

    18/01/2011 

    EN 60601-2-20:1996

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-21:2009

    07/07/2010 

    EN 60601-2-21:1994
    + A1:1996 

    Date expired
    (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
    IEC 60601-2-22:1995

    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
    IEC 60601-2-23:1999

    14/11/2001 

    EN 60601-2-23:1997

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-24:1998

    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
    IEC 60601-2-25:1993

    17/05/1997 

     

     

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

    13/12/2002 

    Note 3 

    Date expired
    (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
    IEC 60601-2-26:2002

    08/11/2005 

    EN 60601-2-26:1994

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-27:2005

    26/07/2006 

    EN 60601-2-27:1994

    Note 2.1 

    Date expired
    (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 60601-2-28:1993

    Medical electrical equipment -- Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
    IEC 60601-2-28:1993

    18/11/1995 

     

     

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

    Cenelec

    EN 60601-2-28:2010

    Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    IEC 60601-2-28:2010

    18/01/2011 

    EN 60601-2-28:1993

    Note 2.1 

    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
    IEC 60601-2-29:2008

    15/07/2009 

    EN 60601-2-29:1999

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-30:1999

    14/11/2001 

    EN 60601-2-30:1995

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-33:2002

    15/10/2003 

    EN 60601-2-33:1995
    + A11:1997

    Note 2.1 

    Date expired
    (01/07/2005) 

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

    27/07/2006 

    Note 3 

    Date expired
    (01/11/2008) 

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

    27/11/2008 

    Note 3 

    Date expired
    (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
    IEC 60601-2-34:2000

    15/10/2003 

    EN 60601-2-34:1995

    Note 2.1 

    Date expired
    (01/11/2003) 

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

    Cenelec

    EN 60601-2-35:1996

    Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
    IEC 60601-2-35:1996

    09/10/1999 

     

     

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

    Cenelec

    EN 60601-2-36:1997

    Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
    IEC 60601-2-36:1997

    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
    IEC 60601-2-37:2007

    27/11/2008 

    EN 60601-2-37:2001
    + A1:2005
    + A2:2005

    Note 2.1 

    Date expired
    (01/10/2010) 

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

    Cenelec

    EN 60601-2-38:1996

    Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds
    IEC 60601-2-38:1996

    09/10/1999 

     

     

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

    14/11/2001 

    Note 3 

    Date expired
    (01/01/2003) 

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

    Cenelec

    EN 60601-2-39:2008

    Medical electrical equipment -- Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
    IEC 60601-2-39:2007

    27/11/2008 

    EN 60601-2-39:1999

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-40:1998

    09/10/1999 

     

     

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

    Cenelec

    EN 60601-2-41:2000

    Medical electrical equipment -- Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
    IEC 60601-2-41:2000

    14/11/2001 

     

     

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

    Cenelec

    EN 60601-2-41:2009

    Medical electrical equipment -- Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
    IEC 60601-2-41:2009

    18/01/2011 

    EN 60601-2-41:2000

    Note 2.1 

    Date expired
    (01/11/2012) 

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

    Cenelec

    EN 60601-2-43:2000

    Medical electrical equipment -- Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
    IEC 60601-2-43:2000

    13/12/2002 

     

     

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

    Cenelec

    EN 60601-2-43:2010

    Medical electrical equipment -- Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
    IEC 60601-2-43:2010

    18/01/2011 

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

    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
    IEC 60601-2-44:2009

    07/07/2010 

    EN 60601-2-44:2001
    + A1:2003

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-45:2001

    14/11/2001 

    EN 60601-2-45:1998

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-46:1998

    14/11/2001 

     

     

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

    Cenelec

    EN 60601-2-47:2001

    Medical electrical equipment -- Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
    IEC 60601-2-47:2001

    13/12/2002 

     

     

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

    Cenelec

    EN 60601-2-49:2001

    Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
    IEC 60601-2-49:2001

    13/12/2002 

     

     

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

    Cenelec

    EN 60601-2-50:2009

    Medical electrical equipment -- Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    IEC 60601-2-50:2009

    07/07/2010 

    EN 60601-2-50:2002

    Note 2.1 

    Date expired
    (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
    IEC 60601-2-51:2003

    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 60601-2-38:1996
    and its amendment
    + EN 1970:2000

    Note 2.1 

    Date expired
    (01/06/2012) 

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

    30/08/2012 

     

     

    (*): Date of cessation of presumption of conformity of superseded standard is corrected (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
    IEC 60601-2-54:2009

    18/01/2011 

    EN 60601-2-7:1998
    + EN 60601-2-28:1993
    + EN 60601-2-32:1994

    Note 2.1 

    Date expired
    (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
    IEC 60627:2001

    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
    IEC 60645-1:2001

    13/12/2002 

    EN 60645-1:1994

    Note 2.1 

    Date expired
    (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
    IEC 60645-2:1993

    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
    IEC 60645-3:2007

    27/11/2008 

    EN 60645-3:1995

    Note 2.1 

    Date expired
    (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
    IEC 60645-4:1994

    23/08/1996 

     

     

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

    Cenelec

    EN 61217:1996

    Radiotherapy equipment - Coordinates, movements and scales
    IEC 61217:1996

    14/11/2001 

     

     

    EN 61217:1996/A1:2001
    IEC 61217:1996/A1:2000

    14/11/2001 

    Note 3 

    Date expired
    (01/12/2003) 

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

    27/11/2008 

    Note 3 

    Date expired
    (01/02/2011) 

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

    Cenelec

    EN 61217:2012

    Radiotherapy equipment - Coordinates, movements and scales
    IEC 61217:2011

    30/08/2012 

    EN 61217:1996
    and its amendments

    Note 2.1 

    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
    IEC 61676:2002

    15/10/2003 

     

     

    EN 61676:2002/A1:2009
    IEC 61676:2002/A1:2008

    07/07/2010 

    Note 3 

    Date expired
    (01/03/2012) 

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

    Cenelec

    EN 62083:2001

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

    13/12/2002 

     

     

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

    Cenelec

    EN 62083:2009

    Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
    IEC 62083:2009

    18/01/2011 

    EN 62083:2001

    Note 2.1 

    Date expired
    (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
    IEC 62220-1:2003

    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
    IEC 62220-1-2:2007

    27/11/2008 

     

     

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

    Cenelec

    EN 62220-1-3:2008

    Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
    IEC 62220-1-3:2008

    15/07/2009 

     

     

    (*): 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
    IEC 62304:2006

    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
    IEC 62366:2007

    27/11/2008 

     

     

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

    Cenelec

    EN 80601-2-35:2009

    Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
    IEC 80601-2-35:2009

    18/01/2011 

    EN 60601-2-35:1996

    Note 2.1 

    Date expired
    (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
    IEC 80601-2-58:2008

    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
    IEC 80601-2-59:2008

    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 requirements of the directive.

    Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

    Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

    Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

     

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