ISO 11607:2019
ISO 11607:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
CDN $376.00
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 16840:2023 Wheelchair seating – Part 14: Concepts related to managing external forces to maintain tissue integrity
CDN $128.00 Add to cart -
ISO 16443:2014 Dentistry – Vocabulary for dental implants systems and related procedure
CDN $130.00 Add to cart -
ISO 24096:2024 Technical product documentation (TPD) – Classification of requirements – Part 2: Classification based on severity and susceptibility
CDN $262.00 Add to cart -
ISO 17097:2024 3-D human body scan data – Methods for the processing of human body scan data
CDN $192.00 Add to cart
