Name: AAMI ISO TIR 22442-4:2011
Brand: AAMI

AAMI ISO TIR 22442-4:2011

Superseded

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

Superseded date

08-31-2021

Language(s)

English

Published date

01-01-2016

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).

DocumentType	Standard
Pages	30
ProductNote	Reconfirmed 2011
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	AAMI/ISO TIR22442-4:2011(R2016)
Supersedes	AAMI ISO TIR 22442-4 : 2010

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