I.S. EN 868-2:2017
Current
The latest, up-to-date edition.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
01-01-2017
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.
National Foreword
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) - 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
Defines 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.
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NS EN 868-2 : 2017 | Identical |
| NBN EN 868-2 : 2009 | Identical |
| NF EN 868-2 : 2017 | Identical |
| EN 868-2:2017 | Identical |
| BS EN 868-2:2017 | Identical |
| DIN EN 868-2:2015-08 (Draft) | Identical |
| NEN EN 868-2 : 2017 | Identical |
| DIN EN 868-2:2017-05 | Equivalent |
| UNE-EN 868-2:2017 | Identical |
| DIN EN 868-2:2017-05 | Identical |
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