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      1. Hi,are you ready?
        準備好開始了嗎?
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        有一個醫療器械項目想和我們談談嗎?您可以填寫右邊的表格,讓我們了解您的項目需求,這是一個良好的開始,我們將會盡快與你取得聯系。當然也歡迎您給我們寫信或是打電話,讓我們聽到你的聲音!

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        醫療器械歐盟CE認證協調標準清單

        MDD協調標準清單

        ESO

        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        Reference of superseded standard

        Date of cessation of presumption of conformity of superseded standard

        CEN

        EN 285:2006+A2:2009 
        Sterilization - Steam sterilizers - Large sterilizers

        02/12/2009 

        EN 285:2006+A1:2008

        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

        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
         

        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

        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

        Date expired
        (21/03/2010) 

        CEN

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

        19/02/2009 

        EN 1041:1998

        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

        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

        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

        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

        Date expired
        (30/04/2010) 

        CEN

        EN 1640:2009 
        Dentistry - Medical devices for dentistry - Equipment

        07/07/2010 

        EN 1640:2004

        Date expired
        (30/04/2010) 

        CEN

        EN 1641:2009 
        Dentistry - Medical devices for dentistry - Materials

        07/07/2010 

        EN 1641:2004

        Date expired
        (30/04/2010) 

        CEN

        EN 1642:2011 
        Dentistry - Medical devices for dentistry - Dental implants

        27/04/2012 

        EN 1642:2009

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        Date expired
        (30/06/2010) 

        EN ISO 5359:2008/A1:2011

        30/08/2012 

        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

        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

        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

        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

        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

        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

        Date expired
        (30/04/2009) 

        EN ISO 7396-1:2007/A1:2010

        07/07/2010 

        Date expired
        (31/07/2010) 

        EN ISO 7396-1:2007/A2:2010

        07/07/2010 

        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

        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

        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

        Date expired
        (21/03/2010) 


        MDD協調標準清單(2)

        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

        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

        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

        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

        Date expired
        (21/03/2010) 

        EN ISO 8835-3:2009/A1:2010

        13/05/2011 

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        Date expired
        (21/03/2010) 

         

        MDD協調標準清單(3)

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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

        Date expired
        (21/03/2010) 

        CEN

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

        02/12/2009 

        EN ISO 11197:2004

        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

        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

        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

        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

        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

        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

        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

        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

        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

        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 

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