BS EN 868-10:2018:2019 Edition
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Packaging for terminally sterilized medical devices – Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 16 |
This document specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with FprEN 868 9 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 |
|---|---|
| 2 | National foreword |
| 5 | European foreword |
| 6 | Introduction |
| 7 | 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 4.1 General |
| 8 | 4.2 Materials 4.3 Performance requirements and test methods |
| 9 | 4.4 Marking of the protective packaging 5 Information to be supplied by the manufacturer |
| 10 | Annex A (informative) Details of significant technical changes between this document and the previous edition |
| 11 | Annex B (normative) Method for the determination of mass per unit area of uncoated nonwoven polyolefine materials and adhesive coating |
| 13 | Annex C (normative) Method for the determination of seal strength and mode of specimen failure |
| 15 | Bibliography |
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BS EN 868-10:2018 – TC:2020 Edition
Tracked Changes. Packaging for terminally sterilized medical devices – Adhesive coated nonwoven materials of polyolefines.…
