I.S. EN 868-8:2018
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
Hardcopy , PDF
English
25-01-2019
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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 document 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 service life with respect to sterilization
Bibliography
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.
| Committee |
TC 102
|
| DocumentType |
Standard
|
| Pages |
26
|
| ProductNote |
THIS STANDARD ALSO REFERS TO- EN ISO 11607-1, EN 1041, EN ISO 11607-2 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 868-8:2018 | Identical |
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