04/30101215 DC : DRAFT APR 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
23-11-2012
31-05-2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Sampling
4.3 Test methods
4.4 Documentation
5 Validation of packaging processes
5.1 General
5.2 Installation qualification (IQ)
5.3 Operational qualification (OQ)
5.4 Performance qualification (PQ)
5.5 Formal approval of the process validation
5.6 Process control and monitoring
5.7 Process changes and revalidation
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid path
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
| Committee |
LBI/35/9
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |