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Sterilization of health care products — Biological indicators — Part 1: General requirements
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 38 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements | 2017-03-03 | 표준 |
| 2 | CAN/CSA-ISO 11138-1:17 (R2022) | Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03) | 2017-01-01 | 표준 |
| 3 | ISO 11138-1:2006 | Sterilization of health care products — Biological indicators — Part 1: General requirements | 2006-06-26 | 구판 |
| 4 | ISO 11138-1:1994 | Sterilization of health care products — Biological indicators — Part 1: General | 1994-10-06 | 구판 |
CAN/CSA-ISO 11138-2:17 (R2022) - Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (Adopted ISO 11138-2:2017, third edition, 2017-03) 상세보기
CAN/CSA-ISO 11138-3:17 (R2022) - Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (Adopted ISO 11138-3:2017, third edition, 2017-03) 상세보기
CAN/CSA-ISO 11138-4:17 (R2022) - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization (Adopted ISO 11138-4:2017, second edition, 2017-03) 상세보기
CAN/CSA-ISO 11138-5:17 (R2022) - Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (Adopted ISO 11138-5:2017, second edition, 2017-03) 상세보기
CAN/CSA-ISO 11138-1:17 (R2022) - Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03) 상세보기
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