ISO 11607:2019
ISO 11607:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
CDN $382.00
Description
This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Edition
2
Published Date
2019-01-31
Status
PUBLISHED
Pages
44
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 20560:2024 Safety information for the content of piping systems and tanks – Part 1: Piping systems
CDN $263.00 Add to cart -
ISO 17097:2024 3-D human body scan data – Methods for the processing of human body scan data
CDN $195.00 Add to cart -
ISO 16520:2025 Tourism and related services – Restaurants and catering – Vocabulary
CDN $195.00 Add to cart -
ISO 9687:2015 Dentistry – Graphical symbols for dental equipment
CDN $310.00 Add to cart
