BS EN ISO 11607-2:2017 – TC:2019 Edition
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Tracked Changes. Packaging for terminally sterilized medical devices – Validation requirements for forming, sealing and assembly processes
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 57 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | compares BS EN ISO 11607-2:2017 |
| 2 | TRACKED CHANGES Test example 1 |
| 3 | BS EN ISO 11607-2:2017 to BS EN ISO 11607-2:2006 |
| 17 | Foreword |
| 18 | Introduction |
| 22 | 4.1 Quality systems 4.2 Sampling 4.3 Test methods |
| 23 | 4.4 Documentation 5.1 General |
| 24 | 5.2 Installation qualification (IQ) |
| 25 | 5.3 Operational qualification (OQ) 5.4 Performance qualification (PQ) |
| 26 | 5.5 Formal approval of the process validation 5.6 Process control and monitoring 5.7 Process changes and revalidation |
| 29 | Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC on medical devices |
| 30 | Bibliography |
| 32 | National foreword |
| 36 | Annex ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 38 | Annex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered |
| 40 | Annex ZC (informative)Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered |
| 43 | Foreword |
| 44 | Introduction |
| 45 | 1 Scope 2 Normative references 3 Terms and definitions |
| 48 | 4 General requirements 4.1 Quality systems 4.2 Sampling 4.3 Test methods |
| 49 | 4.4 Documentation 5 Validation of packaging processes 5.1 General |
| 50 | 5.2 Installation qualification (IQ) 5.3 Operational qualification (OQ) |
| 51 | 5.4 Performance qualification (PQ) |
| 52 | 5.5 Formal approval of the process validation 5.6 Process control and monitoring 5.7 Process changes and revalidation 6 Packaging system assembly |
| 53 | 7 Use of reusable sterile barrier systems 8 Sterile fluid-path packaging |
| 54 | Annex A (informative) Process development |
| 55 | Bibliography |
