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표준
판매
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes.
| 분야 | |
|---|---|
| 적용범위 | Packaging processes, Sterilization (hygiene), Quality assurance systems, Performance testing, Performance, Seals, Packaging materials, Medical equipment, Packaging, Sterile equipment, Acceptance (approval), Quality, Packages, Sealing processes, Medical instruments, Verification, Wrapping |
| 국제분류(ICS)코드 | 11.080.30 : 멸균 포장 |
| 페이지수 | 42 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN ISO 11607-2:2020+A1:2023 | Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. | 2023-11-01 | 표준 |
| 2 | BS EN ISO 11607-2:2020+A11:2022 | Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. | 2022-09-13 | 폐지 |
| 3 | BS EN ISO 11607-2:2020 | Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. | 2020-01-20 | 폐지 |
| 4 | BS EN ISO 11607-2:2017 - TC | Tracked Changes. Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. | 2019-08-09 | 폐지 |
| 5 | BS EN ISO 11607-2:2017 | Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. | 2018-05-15 | 폐지 |
| 6 | BS EN ISO 11607-2:2006+A1:2014 | Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. | 2014-09-30 | 폐지 |
BS EN ISO 11607-1:2006 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. 상세보기
BS EN ISO 11607-1:2009+A1:2014 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. 상세보기
BS EN ISO 11607-2:2006+A1:2014 - Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. 상세보기
BS EN ISO 11607-1:2017 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. 상세보기
BS EN ISO 11607-2:2017 - Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. 상세보기
BS EN ISO 11607-1:2020+A11:2022 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. 상세보기
ISO 2859-1:1999 - Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection 상세보기
ISO 2859-1:1999/Cor 1:2001 - Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection -- Technical Corrigendum 1 상세보기
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
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
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