BS EN ISO 22442-2:2015 – TC:2020 Edition
$186.33
Tracked Changes. Medical devices utilizing animal tissues and their derivatives – Controls on sourcing, collection and handling
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 59 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | compares BS EN ISO 22442-2:2015 |
| 2 | TRACKED CHANGES Text example 1 — indicates added text (in green) |
| 31 | Contents Page |
| 32 | European foreword |
| 34 | Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
| 39 | Foreword |
| 40 | Introduction |
| 42 | 1 Scope 2 Normative references 3 Terms and definitions |
| 43 | 4 General requirements 4.1 General 4.2 Quality system elements |
| 44 | 4.3 Procedures 4.4 Personnel |
| 45 | 4.5 Current regulatory requirements and guidance 5 Sourcing 5.1 General 5.2 Species and strain 5.3 Geography 5.4 Inspection |
| 46 | 5.5 Certification 5.6 Traceability 6 Collection |
| 47 | 7 Handling 8 Storage and transport |
| 48 | Annex A (normative) Additional requirements relating to the application of this part of ISO 22442 to bovine-sourced materials |
| 53 | Annex B (informative) Certification and attestation |
| 55 | Annex C (informative) Veterinary services |
| 56 | Bibliography |
