PREN 868-2 : DRAFT 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
18-08-2015
01-02-2017
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 draft European Standard
and the previous edition
Annex B (informative) - Method for the determination of drape
Annex C (normative) - Method for the determination of
water repellency
Annex D (normative) - Method for the determination
of pore size
Annex E (informative) - Repeatability and reproducibility
of test methods
Bibliography
Gives test methods and values for materials for sterile barrier systems and/or packaging 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 |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 15/30325855 DC : 0 | Identical |
| 07/30166924 DC : DRAFT AUG 2007 | Identical |