AAMI ISO 11607-1 : 2006 : R2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
English
14-12-2010
16-04-2017
Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of ISO 11607-1:2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General
4.2 Quality systems
4.3 Sampling
4.4 Test methods
4.5 Documentation
5 Materials and preformed sterile barrier systems
5.1 General requirements
5.2 Microbial barrier properties
5.3 Compatibility with the sterilization process
5.4 Compatibility with the labelling system
5.5 Storage and transport
6 Design and development requirements for packaging
systems
6.1 General
6.2 Design
6.3 Packaging-system performance testing
6.4 Stability testing
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
Describes 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 |
ST/WG 07
|
| DevelopmentNote |
Supersedes AAMI ISO 11607. (05/2006)
|
| DocumentType |
Standard
|
| Pages |
42
|
| ProductNote |
Reconfirmed 2010
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11607-1:2006 | Identical |
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