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  • EN 13641:2002

    Current The latest, up-to-date edition.

    Elimination or reduction of risk of infection related to in vitro diagnostic reagents

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    Language(s): 

    Published date:  08-05-2002

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements related to design and manufacture
    5 Information supplied by the manufacturer
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other
             provisions of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection. The standard does not apply to the following:- instruments and specimen receptacles;NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is addressed in other relevant International and/or European Standards. - general aspects of workers' protection;- transportation of infectious goods;- disposal measures.NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

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

    Committee CEN/TC 140
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

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

    BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    CSA Z15190 : 2005 : R2010 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    ISO 15190:2003 Medical laboratories Requirements for safety
    BS ISO 15190:2003 Medical laboratories. Requirements for safety
    CSA Z15190 : 2005 : R2015 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
    CSA Z15190 : 2005 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
    ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

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

    EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    89/686/EEC : 1989 AMD 5 2012 COUNCIL DIRECTIVE OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
    CLSI GP17 A : 1ED 96 CLINICAL LABORATORY SAFETY
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