BS EN ISO 11607-2 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
English
01-01-2006
15-05-2018
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 EU Directive 93/42/EEC
on medical devices
Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized, it includes forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 04/30101215 DC (05/2006) Supersedes 14/30255138 DC. 2006 Edition Re-issued in September 2014 & incorporates AMD 1 2014. (09/2014)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 11607-2:2017 & LC:2017 | Identical |
| DIN EN ISO 11607-2:2014-11 | Identical |
| NS EN ISO 11607-2 : 2017 | Identical |
| NBN EN ISO 11607-2 : 2006 AMD 1 2014 | Identical |
| EN ISO 11607-2:2017 | Identical |
| ISO 11607-2:2006 | Identical |
| EN ISO 11607-2:2006 | Equivalent |
| DIN EN ISO 11607-2:2006-07 | Equivalent |
| I.S. EN ISO 11607-2:2006 | Equivalent |
| UNE-EN ISO 11607-2:2017 | Identical |
| NF EN ISO 11607-2:2018 | Identical |
| UNE-EN ISO 11607-2:2006 | Equivalent |
| NEN EN ISO 11607-2 : 2017 + COR 2017 | Identical |
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