UNI 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
09-05-2019
01-01-2009
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
Supplies 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
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN 868-8:2009 | Identical |
| ONORM EN 868-8 : 2009 | Identical |
| SN EN 868-8 : 2009 | Identical |
| BS EN 868-8:2009 | Identical |
| NBN EN 868-8 : 2009 | Identical |
| NF EN 868-8 : 2009 | Identical |
| NS EN 868-8 : 2009 | Identical |
| UNE-EN 868-8:2009 | Identical |
| NEN EN 868-8 : 2009 | Identical |
| EN 868-8:2018 | Identical |
| DIN EN 868-8:2009-09 | 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.