BS EN 868-9:2018 – TC:2020 Edition
$112.35
Tracked Changes. Packaging for terminally sterilized medical devices – Uncoated nonwoven materials of polyolefines. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 26 |
This document specifies test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication |
| 6 | ForewordEuropean foreword |
| 7 | Introduction |
| 8 | 1 Scope 2 Normative references |
| 9 | 3 Terms and definitions 4 Requirements 4.1 General |
| 10 | 4.2 Materials 4.3 Performance requirements and test methods 4.3.1 General |
| 11 | 4.3.2 Specific performance requirements and test methods 4.3.2.2 Polypropylene based materials 4.4 Marking of the protective packaging 5 Information to be supplied by the manufacturer |
| 12 | Annex A (informative) |
| 14 | Bibliography |
| 16 | undefined |
| 21 | 1 Scope 2 Normative references 3 Terms and definitions |
| 22 | 4 Requirements 4.1 General 4.2 Materials 4.3 Performance requirements and test methods 4.3.1 General |
| 23 | 4.3.2 Specific performance requirements and test methods 4.3.2.1 Polyethylene based materials 4.3.2.2 Polypropylene based materials 4.4 Marking of the protective packaging 5 Information to be supplied by the manufacturer |
| 24 | Annex A (informative)Details of significant technical changes between this document and the previous edition |
