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Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes.
| 분야 | |
|---|---|
| 적용범위 | Packages, Packaging materials, Quality, Verification, Seals, Sterilization (hygiene), Sterile equipment, Packaging, Wrapping, Packaging processes, Medical equipment, Sealing processes, Medical instruments, Performance, Performance testing, Quality assurance systems, Acceptance (approval) |
| 국제분류(ICS)코드 | 11.080.30 : 멸균 포장 |
| 페이지수 | 32 |
| 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
ASTM F1980-21 REDLINE - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices 상세보기
ASTM F1608-21 REDLINE - Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) 상세보기
ASTM D882-18 REDLINE - Standard Test Method for Tensile Properties of Thin Plastic Sheeting 상세보기
ASTM F1929-15 REDLINE - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration 상세보기
ASTM F1140/F1140M-13 REDLINE - Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages 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
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