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ANSI/AAMI/ISO 22442-2:2016

Current
Current

The latest, up-to-date edition.

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

17-11-2016

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

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.

Committee
ISO/TC 194
DocumentType
Greenline
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 22442-2:2015 Identical

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

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