I.S. EN ISO 11607-1:2017&LC:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
Hardcopy , PDF
29-01-2020
English
13-12-2017
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials and preformed sterile barrier systems
6 Design and development requirements for packaging systems
7 Information to be provided
Annex A (informative) Guidance on medical packaging
Annex B (informative) Standardized test methods and procedures that may be used to
demonstrate compliance with the requirements of this part of ISO 11607
Annex C (normative) Test method for resistance of impermeable materials to the passage of air
Bibliography
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
| Committee |
TC 198
|
| DocumentType |
Test Method
|
| Pages |
66
|
| ProductNote |
THIS STANDARD ALSO REFERS- ANSI/AAMI ST65:2000 , EN 14180:2003 , EN 13795-1:2002 , EN 1422:1997 , EN 868-10:2000 , EN 868-9:2000 , EN 868-8:1999 , EN 868-7:1999 , EN 868-6:1999 , EN 868-5:1999 , EN 868-4:1999 , EN 868-3:1999 , EN 868-2:1999 , EN 552:1994 , EN 285:1996 , 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 |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 11607-1:2017 | Identical |
| ISO 11607-1:2006 | Identical |
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