BS EN 868-8:2018:2019 Edition
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Packaging for terminally sterilized medical devices – Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
Published By | Publication Date | Number of Pages |
BSI | 2019 | 22 |
This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285. NOTE 1 The need for a packaging material inside the container is determined by the manufacturers and users. 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. NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle, e.g. operating temperature. NOTE 3 The use of additional materials and/or accessories inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) is not covered in this part of EN 868. However, other requirements, including the determination of the acceptability of these materials and/or accessories during validation activities, can apply.
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 Requirements for construction and design 4.2.1 Shape and dimension 4.2.2 Lids and lid-latching devices 4.2.3 Tamper evident closure system 4.2.4 Gasket |
9 | 4.2.5 Carrying devices 4.2.6 Stacking capability 4.2.7 Sterilizing agent port 4.2.8 Load |
10 | 4.3 Service life 4.4 Material requirements |
11 | 4.5 Marking 5 Information to be supplied by the manufacturer |
12 | Annex A (informative) Details of significant technical changes between this document and the previous edition |
13 | Annex B (informative) Guidance on dimensions |
14 | Annex C (normative) Carrying device strength test |
15 | Annex D (normative) Stacking test — Procedure |
16 | Annex E (normative) Stacking device capability test |
17 | Annex F (normative) Determination of sterilization performance |
18 | Annex G (normative) Load dryness tests |
20 | Annex H (informative) Guidance on determination of service life with respect to sterilization |
21 | Bibliography |