I.S. EN ISO 11607-2:2017 & LC:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006, INCLUDING AMD 1:2014)
Hardcopy , PDF
01-01-2017
23-01-2020
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.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Validation of packaging processes
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) - Process development
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the essential
requirements of Directive 93/42/EEC
[OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between this
European Standard and the essential
requirements of Directive 90/385/EEC
[OJ L 189] aimed to be covered
Annex ZC (informative) - Relationship between this
European Standard and the essential
requirements of Directive 98/79/EC
[OJ L 331] aimed to be covered
Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized.
| Committee |
TC 198
|
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 11607-2:2006 | Identical |
| BS EN ISO 11607-2 : 2006 | Identical |
| NBN EN ISO 11607-2 : 2006 AMD 1 2014 | Identical |
| DIN EN ISO 11607-2:2014-11 | Identical |
| NS EN ISO 11607-2 : 2017 | Identical |
| EN ISO 11607-2:2017 | Identical |
| UNE-EN ISO 11607-2:2017 | Identical |
| NF EN ISO 11607-2:2018 | Identical |
| DIN EN ISO 11607-2:2017-10 | Equivalent |
| BS EN ISO 11607-2:2017 | Equivalent |
| NEN EN ISO 11607-2 : 2017 + COR 2017 | Identical |
A newer version of this standard is available.
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