PREN 868-8 : DRAFT 2017
Current
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
08-22-2017
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 |