BS EN ISO 22442-2:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling
Hardcopy , PDF
14-12-2020
English
31-12-2015
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Superseded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 |
Standards | Relationship |
NF EN ISO 22442-2 : 2016 | Identical |
NBN EN ISO 22442-2 : 2015 | Identical |
NS EN ISO 22442-2 : 2007 | Identical |
SN EN ISO 22442-2 : 2016 | Identical |
I.S. EN ISO 22442-2:2015 | Identical |
DIN EN ISO 22442-2:2016-05 | Identical |
ISO 22442-2:2015 | Identical |
NEN EN ISO 22442-2 : 2015 | Identical |
EN ISO 22442-2:2015 | Identical |
ONORM EN ISO 22442-2 : 2016 | 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 |
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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