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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Adopted ISO 11137-2:2013, third edition, 2013-06-01)
| 분야 | |
|---|---|
| 적용범위 | Preface This is the second edition of CAN/CSA-ISO 11137-2, Sterilization of health care products ? Radiation ? Part 2: Establishing the sterilization dose, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-2 (third edition, 2013-06-01). It supersedes the previous edition published in 2007 as CAN/CSA-Z11137-2 (adopted ISO 11137-2:2006). For brevity, this Standard will be referred to as "CAN/CSA-ISO 11137-2" throughout.? Scope This part of ISO 11137 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. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.? This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit. |
| 국제분류(ICS)코드 | |
| 페이지수 | 91 |
| Edition |
| 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
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
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