ISO 11607-1:2006
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
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.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD | |
| HardCopy |
$152.17 NZD | |
| Networkable PDF |
Price varies
|
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
- BS 6256:2021
Packaging for terminally-sterilized medical devices. Method for determination of methylene blue particulate penetration
- BS EN 868-10:2018
Packaging for terminally sterilized medical devices, Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
- BS EN 868-10:2018 - TC
Tracked Changes. Packaging for terminally sterilized medical devices, Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
- BS EN 868-2:2025
Packaging for terminally sterilized medical devices, Sterilization wrap. Requirements and test methods