Skip to content
Please enter a keyword to search

  • ANSI/AAMI/ISO 22442-2:2016

    Current The latest, up-to-date edition.

    MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING

    Available format(s): 

    Language(s): 

    Published date:  17-11-2016

    Publisher:  Association for the Advancement of Medical Instrumentation

    Sorry this product is not available in your region.

    Add To Cart

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of
     ISO 22442-2:2016
    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

    Abstract - (Show below) - (Hide below)

    Describes 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 ISO/TC 194
    Document Type Greenline
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    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
    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective