ISO 11607-1:2019
2019-02
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.
General information
-
Status: PublishedPublication date: 2019-02Stage: Close of review [90.60]
-
Edition: 2Number of pages: 44
-
Technical Committee :ISO/TC 198ICS :11.080.30
- RSS updates
Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Life cycle
-
Previously
WithdrawnISO 11607-1:2006
WithdrawnISO 11607-1:2006/Amd 1:2014
-
Now
-
00
Preliminary
-
10
Proposal
-
20
Preparatory
-
30
Committee
-
40
Enquiry
-
50
Approval
-
60
Publication
-
90
Review
-
95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedISO 11607-1:2019/Amd 1:2023
-
00
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)