BS EN 868-5:2018 – TC:2019 Edition
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Tracked Changes. Packaging for terminally sterilized medical devices – Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 50 |
This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as 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 document. The materials specified in this part of EN 868 are intended for single use only.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | compares BS EN 868-5:2018 |
| 2 | TRACKED CHANGES Test example 1 |
| 3 | BS EN 868-5:2018 to BS EN 868-5:2009 |
| 5 | Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication |
| 6 | Packaging for terminally sterilized medical devices ‑ Part 5: Sealable pouches and reels of porous materials and plastic film construction ‑ Requirements and test methods |
| 8 | Foreword European foreword |
| 9 | Introduction |
| 10 | 1 Scope 2 Normative references |
| 11 | 3 Terms and definitions 3.1 4 Requirements 4.1 General 4.2 Materials 4.2.1 Porous material |
| 12 | 4.2.2 Plastic film 4.3 Construction and design |
| 13 | 4.4 Process indicator 4.5 Performance requirements and test methods 4.6 Marking 4.6.1 Pouches and reels |
| 14 | 4.6.2 Protective Transport and/or storage packaging 5 Information to be supplied by the manufacturer |
| 17 | Annex B (normative) B.1 Preparation of test specimens B.2 Procedure B.3 Test report |
| 18 | C.1 Apparatus and reagents C.1.4 A flat glass surface. C.2 Preparation of test pieces C.3 Procedure |
| 19 | C.4 Test report |
| 20 | Annex D (normative) D.1 Units D.2D.1 Principle of the method D.2 Test method D.3 Apparatus D.3.1 Tensile tester D.4D.3 Preparation of test piecesspecimen — Instructions for sampling D.4.1 Dry |
| 21 | D.4.2 Dry, sterilized D.5 D.4 Procedure Figure D.1 — Example of seal profile of a flat seal |
| 23 | Annex E (normative) E.1 Apparatus E.2 Procedure Figure E.1 — Clean peel appearance with no splitting of paper direction inside |
| 24 | E.3 Test report |
| 25 | Annex F (normative) F.1 Apparatus F.2 Procedure F.3 Test report |
| 26 | Bibliography |
| 28 | National foreword |
| 31 | European foreword |
| 32 | Introduction |
| 33 | 1 Scope 2 Normative references 3 Terms and definitions |
| 34 | 4 Requirements 4.1 General 4.2 Materials 4.2.1 Porous material 4.2.2 Plastic film |
| 35 | 4.3 Construction and design 4.4 Process indicator 4.5 Performance requirements and test methods |
| 36 | 4.6 Marking 4.6.1 Pouches and reels 4.6.2 Transport and/or storage packaging |
| 37 | 5 Information to be supplied by the manufacturer |
| 38 | Annex A (informative) Details of significant technical changes between this document and the previous edition |
| 39 | Annex B (normative) Method for the determination of resistanceto the intended sterilization process |
| 40 | Annex C (normative) Method for the determination of pinholes in plastic laminate |
| 42 | Annex D (normative) Method for the determination of the strength of the seal for pouches and reel material |
| 45 | Annex E (normative) Method for the determination of peel characteristics of paper/plastic laminate products |
| 47 | Annex F (normative) Method for the determination of fibre orientation |
| 48 | Bibliography |
