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  • BS EN ISO 22442-2:2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-12-2020

    Language(s):  English

    Published date:  31-12-2015

    Publisher:  British Standards Institution

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Sourcing
    6 Collection
    7 Handling
    8 Storage and transport
    Annex A (normative) - Additional requirements relating
            to the application of this part of ISO 22442
            to bovine-sourced materials
    Annex B (informative) - Certification and attestation
    Annex C (informative) - Veterinary services
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Provides requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices.

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

    Committee BTI/1
    Development Note Supersedes BS EN 12442-2 and 05/30106194 DC. (02/2008)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    ISO 9001:2015 Quality management systems — Requirements
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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