PREN 868-8 : DRAFT 2017
Current
The latest, up-to-date edition.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
22-08-2017
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) - Details of significant technical
changes between this European Standard and the
previous edition
Annex B (informative) - Guidance on dimensions
Annex C (normative) - Carrying device strength test
Annex D (normative) - Stacking test - Procedure
Annex E (normative) - Stacking device capability test
Annex F (normative) - Determination of sterilization
performance
Annex G (normative) - Load dryness tests
Annex H (informative) - Guidance on determination
of useful life with respect tO sterilization
Bibliography
Describes 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.
| Committee |
TC 102
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| 17/30360915 DC : 0 | Identical |
| 17/30360915 DC : DRAFT AUG 2017 | Identical |
| 07/30167330 DC : DRAFT AUG 2007 | Identical |
| BS EN 868-1:1997 | Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 4017:2014 | Fasteners Hexagon head screws Product grades A and B |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 4582:2017 | Plastics — Determination of changes in colour and variations in properties after exposure to glass-filtered solar radiation, natural weathering or laboratory radiation sources |
| EN ISO 4017:2014 | Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014) |
| PREN ISO 17664 : DRAFT 2001 | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| EN 10088-1:2014 | Stainless steels - Part 1: List of stainless steels |
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