MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 4: PRINCIPLES FOR ELIMINATION AND/OR INACTIVATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS AND VALIDATION ASSAYS FOR THOSE PROCESSES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-12-2016

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of US adoption of ISO/TR 22442-4:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Elimination of TSE agents: basic considerations
5 Potential methods to eliminate TSE agents
6 Experimental validation of methods for eliminating
TSE agents from medical devices utilizing non-viable
animal tissues
Bibliography

Provides suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs).

Committee	ISO/TC 194
DocumentType	Technical Report
ISBN	978-1-57020-669-6
Pages	30
ProductNote	Reconfirmed 2016
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	AAMI ISO TIR 22442-4:2011

Standards	Relationship
ISO/TR 22442-4:2010	Identical

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 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ISO 22442-2:2015	Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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

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AAMI/ISO TIR22442-4:2011(R2016)

MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 4: PRINCIPLES FOR ELIMINATION AND/OR INACTIVATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS AND VALIDATION ASSAYS FOR THOSE PROCESSES

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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