ISO 11607-1:2019
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
31-01-2019
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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.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
44
|
| ProductNote |
This standard also refer to ANSI/AAMI ST65,ANSI/AAMI ST77,ANSI/AAMI ST79,ANSI/AAMI ST90,
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DS/EN ISO 11607-1:2020 | Identical |
| DS/ISO 11607-1:2019 | Identical |
| IS/ISO 11607 : Part 1 : 2019 | Identical |
| PN-EN ISO 11607-1:2020-06/A11:2022-12 | Identical |
| EN ISO 11607-1:2017 | Identical |
| EN ISO 11607-1:2020 | Identical |
| I.S. EN ISO 11607-1:2020 | Identical |
| NEN-EN-ISO 11607-1:2020 | Identical |
| UNI EN ISO 11607-1:2020 | Identical |
| ÖNORM EN ISO 11607-1: 2020 04 15 | Identical |
| I.S. EN ISO 11607-1:2020&LC:2020 | Identical |
| NS EN ISO 11607-1:2020 | Identical |
| PN-EN ISO 11607-1:2020-06 | Identical |
| UNI EN ISO 11607-1:2022 | Identical |
| NS-EN ISO 11607-1:2020/A11:2022 | Identical |
| NF EN ISO 11607-1:2020 | Identical |
| UNI EN ISO 11607-1:2023 | Identical |
| UNE-EN ISO 11607-1:2020 | Identical |
| DIN EN ISO 11607-1:2020-05 | Identical |
| ONORM EN ISO 11607-1:2022 12 01 | Identical |
| BS EN ISO 11607-1:2020 | Identical |
| NASA-STD-8719.27:2022 | IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT |
| SA HB 13485:2020 | AS ISO 13485:2017 - Medical devices - A practical guide |
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