관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
폐지
판매
Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems.
| 분야 | |
|---|---|
| 적용범위 | Sterilization (hygiene), Quality, Performance, Compatibility, Quality assurance systems, Packaging, Seals, Design, Packages, Test methods, Wrapping, Sterile equipment, Performance testing, Medical equipment, Packaging materials, Medical instruments |
| 국제분류(ICS)코드 | 11.080.30 : 멸균 포장 |
| 페이지수 | 58 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN ISO 11607-1:2020+A1:2023 | Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. | 2023-11-06 | 표준 |
| 2 | BS EN ISO 11607-1:2020+A11:2022 | Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. | 2022-09-16 | 폐지 |
| 3 | BS EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. | 2020-03-03 | 폐지 |
| 4 | BS EN ISO 11607-1:2017 - TC | Tracked Changes. Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. | 2019-08-02 | 폐지 |
| 5 | BS EN ISO 11607-1:2017 | Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. | 2018-05-15 | 폐지 |
| 6 | BS EN ISO 11607-1:2009+A1:2014 | Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. | 2014-08-31 | 폐지 |
| 7 | BS EN ISO 11607-1:2006 | Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. | 2006-05-31 | 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 11607-2:2020 - Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes. 상세보기
ISO/TR 80002-2:2017 - Medical device software — Part 2: Validation of software for medical device quality systems 상세보기
ISO/TR 24971:2020 - Medical devices — Guidance on the application of ISO 14971 상세보기
BS EN ISO 7886-1:2018 - Sterile hypodermic syringes for single use. Syringes for manual use. 상세보기
BS EN 60601-1:2006+A12:2014 - Medical electrical equipment. General requirements for basic safety and essential performance. 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
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
KS표준
핸드북
