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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 68 |
| Edition | 3 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11137-2:2013/Amd 1:2022 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1 | 2022-06-13 | 표준 |
| 2 | CSA ISO 11137-2:16 (R2021) | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Adopted ISO 11137-2:2013, third edition, 2013-06-01) | 2016-01-01 | 표준 |
| 3 | ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose | 2013-05-21 | 표준 |
| 4 | ISO 11137-2:2012 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose | 2012-03-15 | 구판 |
| 5 | ISO 11137-2:2006/Cor 1:2009 | 2009-02-10 | 구판 | |
| 6 | ISO 11137-2:2006 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose | 2006-04-19 | 구판 |
ISO/FDIS 11137-1 - Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 상세보기
ISO 11137-1:2006 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 상세보기
ISO 11137-1:2006/Amd 1:2013 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1 상세보기
CSA ISO 11137-2:16 (R2021) - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Adopted ISO 11137-2:2013, third edition, 2013-06-01) 상세보기
CAN/CSA-ISO 11137-3:17 (R2022) - Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control (Adopted ISO 11137-3:2017, second edition, 2017-06) 상세보기
ISO 11137-3:2017 - Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control 상세보기
ISO 11137-1:2006 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 상세보기
ISO 11137-1:2006/Amd 2:2018 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2 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
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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