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  • 2007/47/EC : 2007 COR 1 2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)

    Available format(s): 

    Superseded date:  05-04-2017

    Language(s): 

    Published date:  12-01-2013

    Publisher:  European Union

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    Development Note COR 1 is only available in Bulgarian, Spanish, Czech, French, Croatian, Latvian, Lithuanian, Polish and Slovak language. (04/2017) Superseded by 2017/745/EU, but remains valid until 25/05/2020. (09/2017)
    Document Type Miscellaneous Product
    Publisher European Union
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    08/30184612 DC : DRAFT SEP 2008 BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
    I.S. EN ISO 11615:2017 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO 11615:2017)
    UNE-EN ISO 11616:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)
    CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
    NF EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    15/30321267 DC : DRAFT FEB 2015 BS EN 50527-1 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
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    BS PAS 84(2008) : 2008 REGENERATIVE MEDICINE - GLOSSARY
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    I.S. EN ISO 11616:2017 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO 11616:2017)
    PREN 12182 : 2009-06 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
    BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
    BS EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
    NF EN 13544-3 : 2002 + A1 2009 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    PREN 50527-1 : DRAFT 2015 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
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    08/30184602 DC : DRAFT SEP 2008 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
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    17/30250386 DC : 0 BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS
    09/30201992 DC : 0 BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
    BS ISO 23409:2011 Male condoms. Requirements and test methods for condoms made from synthetic materials
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    BS EN 50527-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices General
    UNE-EN ISO 11615:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012)
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    CEN/TR 16953:2017 Medical gloves for single use - Guidance for selection
    EN ISO 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
    EN ISO 11616:2017 Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
    S.R. CEN/TR 16953:2017 MEDICAL GLOVES FOR SINGLE USE - GUIDANCE FOR SELECTION
    13/30271473 DC : 0 BS EN 80601-2-58 - 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
    15/30282343 DC : 0 BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
    PD CEN/TR 12401:2009 Dentistry. Guidance on the classification of dental devices and accessories
    13/30259011 DC : 0 BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
    ISO 18746:2016 Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
    16/30344636 DC : 0 BS EN ISO 11615 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION
    I.S. EN 50527-1:2016 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL
    16/30344632 DC : 0 BS EN ISO 11616 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION
    BS EN 14683:2014 Medical face masks. Requirements and test methods
    ISO 23409:2011 Male condoms Requirements and test methods for condoms made from synthetic materials
    EN 14683:2014 Medical face masks - Requirements and test methods
    BS EN ISO 14602:2011 Non-active surgical implants. Implants for osteosynthesis. Particular requirements
    BS EN 1641:2004 Dentistry. Medical devices for dentistry. Materials
    EN ISO 14602:2011 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
    EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
    EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
    EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
    UNE-EN 50527-1:2011 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
    ISO 17327-1:2018 Non-active surgical implants — Implant coating — Part 1: General requirements
    ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    ISO 17218:2014 Sterile acupuncture needles for single use
    View more information

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