BS EN ISO 11607-2:2017:2018 Edition
$142.49
Packaging for terminally sterilized medical devices – Validation requirements for forming, sealing and assembly processes
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 26 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 6 | Annex ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 8 | Annex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered |
| 10 | Annex ZC (informative)Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 18 | 4 General requirements 4.1 Quality systems 4.2 Sampling 4.3 Test methods |
| 19 | 4.4 Documentation 5 Validation of packaging processes 5.1 General |
| 20 | 5.2 Installation qualification (IQ) 5.3 Operational qualification (OQ) |
| 21 | 5.4 Performance qualification (PQ) |
| 22 | 5.5 Formal approval of the process validation 5.6 Process control and monitoring 5.7 Process changes and revalidation 6 Packaging system assembly |
| 23 | 7 Use of reusable sterile barrier systems 8 Sterile fluid-path packaging |
| 24 | Annex A (informative) Process development |
| 25 | Bibliography |
Related products
-
BS EN ISO 11607-2:2017 – TC:2019 Edition
Tracked Changes. Packaging for terminally sterilized medical devices – Validation requirements for forming, sealing and…
