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  • BS EN 1041 : 2008

    Current The latest, up-to-date edition.

    INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-08-2008

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Requirements for provision of information
    6 Documentation
    Annex A (informative) - Requirements and guidance for
            Directives 93/42/EEC and 90/385/EEC, as amended
    Annex B (informative) - Guidance on alternative labelling for
            instructions for use (IFU)
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of
             EU Directive 93/42/EC
    Annex ZB (informative) - Relationship between this European
             Standard and the Essential Requirements of
             EU Directive 90/385/EC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices.

    General Product Information - (Show below) - (Hide below)

    Committee CH/210/3
    Development Note Supersedes 93/502178 DC. (07/2005) Supersedes 06/30123163 DC. (09/2008) 2008 Edition Re-Issued in October 2013 & incorporates AMD 1 2013. Supersedes 13/30272487 DC. (10/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
    04/30080998 DC : DRAFT JUL 2004 BS 4751 - MOBILE SANITARY CHAIRS
    BS 8432:2005 Spinal orthoses. Guide to design
    04/19986965 DC : DRAFT NOV 2004 BS 8432 - SPINAL ORTHOSES - GUIDE TO DESIGN

    Standards Referencing This Book - (Show below) - (Hide below)

    EN ISO 780:2015 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages (ISO 780:2015)
    ISO 639-1:2002 Codes for the representation of names of languages — Part 1: Alpha-2 code
    EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
    EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
    2004/108/EC : 2004 DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 DECEMBER 2004 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ELECTROMAGNETIC COMPATIBILITY AND REPEALING DIRECTIVE 89/336/EC
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
    EN ISO 3166-1:2014 Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1:2013)
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
    ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions Part 1: Country codes
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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