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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 11137-2:2006 specifies methods of 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2006 defines product families for dose establishment and dose auditing. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 60 |
| Edition | 1 |
| 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 11137-2:2013 - Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose 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
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