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BS EN ISO 22442-2:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling
Available format(s)

Hardcopy , PDF

Superseded date

12-14-2020

Language(s)

English

Published date

12-31-2015

Publisher

British Standards Institution

European foreword
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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Provides 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
BTI/1
DevelopmentNote
Supersedes BS EN 12442-2 and 05/30106194 DC. (02/2008)
DocumentType
Standard
Pages
32
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
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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Hardcopy - English
PDF - English
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