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Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | 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. |
| 국제분류(ICS)코드 | 11.080.30 : 멸균 포장 |
| 페이지수 | 44 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11607-1:2019/Amd 1:2023 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management | 2023-09-13 | 표준 |
| 2 | CSA ISO 11607-1:21 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02) | 2021-01-01 | 표준 |
| 3 | ISO 11607-1:2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems | 2019-01-31 | 표준 |
| 4 | ISO 11607-1:2006/Amd 1:2014 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1 | 2014-07-07 | 구판 |
| 5 | ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems | 2006-04-07 | 구판 |
ISO 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 상세보기
CSA ISO 11607-1:21 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02) 상세보기
CSA ISO 11607-2:21 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02) 상세보기
ISO 11607-2:2019/Amd 1:2023 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management 상세보기
ISO 11607-1:2019/Amd 1:2023 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management 상세보기
ISO 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 상세보기
ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
ISO 11737-2:2019 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
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