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Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations. |
| 국제분류(ICS)코드 | 11.080.30 : 멸균 포장 |
| 페이지수 | 11 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | 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 | 2023-09-13 | 표준 |
| 2 | 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) | 2021-01-01 | 표준 |
| 3 | ISO 11607-2:2019 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes | 2019-01-31 | 표준 |
| 4 | ISO 11607-2:2006/Amd 1:2014 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1 | 2014-07-07 | 구판 |
| 5 | ISO 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes | 2006-04-07 | 구판 |
ISO 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems 상세보기
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
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