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    I.S. EN 12442-3:2000

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    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

    Available format(s):  Hardcopy, PDF

    Superseded date:  12-02-2008

    Language(s):  English

    Published date:  01-01-2000

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Literature search
    6 Elimination and/or inactivation study of viruses and
      transmissible agents
    7 Final report
    8 Review of final report
    9 Routing monitoring and control of critical process
      parameters
    Annex A (normative) Requirements related to literature search
    Annex B (informative) Guidance on scaling down
    Annex C (informative) Guidance on the elimination and/or
                          inactivation study for viruses and
                          transmissible agents ('agents')
    Annex D (informative) Statistical evaluation of virus titres
                          and reduction factors and assessment of
                          their validity
    Annex E (informative) Calculation of reduction factors
    Annex F (informative) Probability of detection of agents at
                          low concentrations
    Annex ZA (informative) Clauses of this standard addressing
                           Essential Requirements or other
                           provisions of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices utilizing materials of animal origin.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 1174-3 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    EN 1174-2 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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