AAMI ISO 11607-2:2006
Superseded
View Superseded by
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
English
12-09-2005
06-07-2019
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11607-2:2006
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 packaging
Annex A (informative) Process development
Bibliography
Describes the requirements for development and validation of processes for packaging medical devices that are terminally sterilized.
| Committee |
ST/WG 07
|
| DevelopmentNote |
Supersedes AAMI ISO 11607 (05/2006)
|
| DocumentType |
Standard
|
| Pages |
36
|
| ProductNote |
Reconfirmed 2006 NEW CHILD AMD 1 2014 IS NOW ADDED.
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11607-2:2006 | Identical |