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
11-17-2016
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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