I.S. EN 868-8:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-01-2009
25-01-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
6 Test methods
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) Handle strength test
Annex D (normative) Stacking test
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
Bibliography
Gives 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.
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| BS EN 868-8:2009 | Identical |
| NBN EN 868-8 : 2009 | Identical |
| NF EN 868-8 : 2009 | Identical |
| NS EN 868-8 : 2009 | Identical |
| NEN EN 868-8 : 2009 | Identical |
| DIN EN 868-8:2009-09 | Identical |
| ONORM EN 868-8 : 2009 | Identical |
| UNE-EN 868-8:2009 | Identical |
| EN 868-8:2009 | Identical |
| 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) |
| 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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