BS EN ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives – Controls on sourcing, collection and handling
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 32 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Contents Page |
| 5 | European foreword |
| 7 | Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 General requirements 4.1 General 4.2 Quality system elements |
| 17 | 4.3 Procedures 4.4 Personnel |
| 18 | 4.5 Current regulatory requirements and guidance 5 Sourcing 5.1 General 5.2 Species and strain 5.3 Geography 5.4 Inspection |
| 19 | 5.5 Certification 5.6 Traceability 6 Collection |
| 20 | 7 Handling 8 Storage and transport |
| 21 | Annex A (normative) Additional requirements relating to the application of this part of ISO 22442 to bovine-sourced materials |
| 26 | Annex B (informative) Certification and attestation |
| 28 | Annex C (informative) Veterinary services |
| 29 | Bibliography |
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BS EN ISO 22442-2:2015 – TC:2020 Edition
Tracked Changes. Medical devices utilizing animal tissues and their derivatives – Controls on sourcing, collection…
