ISO 11607-1:2006
Withdrawn
View Superseded by
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Hardcopy , PDF
04-07-2006
04-09-2025
ISO 11607-1:2006 specifies 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.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO 11607. (04/2006) DRAFT ISO/DIS 11607-1 is also available for this standard. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
A newer version of this standard is available.
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