BS EN ISO 11607-1:2017 – TC:2019 Edition
$217.84
Tracked Changes. Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems and packaging systems
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 94 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | compares BS EN ISO 11607-1:2017 |
| 2 | TRACKED CHANGES Test example 1 |
| 3 | BS EN ISO 11607-1:2017 to BS EN ISO 11607-1:2009 |
| 5 | National foreword Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication |
| 7 | ForewordEuropean foreword Table — Correlation between normative references and dated EN and ISO standards |
| 9 | Annex ZA (informative) |
| 10 | Table ZA.1 — Correspondence between this European Standard and Annex I of Directive 93/42/EEC [OJ L 169] |
| 12 | Annex ZB (informative) Table ZB.1 — Correspondence between this European Standard and Annex I of Directive 90/385/EEC [OJ L 189] |
| 14 | Annex ZC (informative) Table ZC.1 — Correspondence between this European Standard and Annex I of Directive 98/79/EC [OJ L 331] |
| 17 | Foreword |
| 18 | Introduction |
| 19 | Packaging for terminally sterilized medical devices — 1 Scope 2 Normative references 3 Terms and definitions 3.1 aseptic presentation introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination 3.2 bioburden population of viable microorganisms on or in a product or sterile barrier system [SOURCE: ISO/TS 11139:2006] |
| 20 | 3.3 3.4 3.5 3.6 3.7 3.8 |
| 21 | 3.9 3.10 3.11 3.12 3.13 3.14 3.15 |
| 22 | 3.16 3.17 3.18 3.19 3.20 3.21 3.22 |
| 23 | 3.23 3.24 3.25 3.26 3.27 3.28 3.29 4 General requirements 4.1 General 4.2 Quality systems |
| 24 | 4.3 Sampling 4.4 Test methods 4.5 Documentation |
| 25 | 5 Materials and preformed sterile barrier systems 5.1 General requirements |
| 27 | 5.2 Microbial barrier properties |
| 28 | 5.3 Compatibility with the sterilization process 5.4 Compatibility with the labelling system |
| 29 | 5.5 Storage and transport 6 Design and development requirements for packaging systems 6.1 General 6.2 Design |
| 30 | 6.3 Packaging-system performance testing |
| 31 | 6.4 Stability testing 7 Information to be provided |
| 32 | (informative) A.1 Factors influencing the choice of the materials and design of the packaging system Figure A.1 — Interrelationships influencing the choice of appropriate materials for terminally sterilized medical packaging systems A.3 Sterile barrier systems |
| 35 | Annex B (informative) B.1 General B.2 Packaging materials and preformed sterile barrier systems Table B.1 — Test methods and their status |
| 47 | Annex C (normative) |
| 48 | Bibliography |
| 52 | undefined |
| 56 | Annex ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 58 | Annex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered |
| 60 | Annex ZC (informative)Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered |
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