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표준
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Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices.
| 분야 | |
|---|---|
| 적용범위 | Gamma-radiation, Radiation measurement, Ionizing radiation, Sterilization (hygiene), Quality assurance, Medical instruments, Medical equipment, Documents, Process specification, Electron beams, Medical technology, Records (documents), Calibration, X-rays, Verification, Maintenance, Radiation, Quality control |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 62 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN ISO 11137-1:2015+A2:2019 | Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices. | 2019-11-27 | 표준 |
| 2 | BS EN ISO 11137-1:2015 | Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices. | 2015-07-31 | 폐지 |
| 3 | BS EN ISO 11137-1:2006+A1:2013 | Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices. | 2013-08-31 | 폐지 |
BS EN ISO 11137-3:2006 - Sterilization of health care products. Radiation. Guidance on dosimetric aspects. 상세보기
BS EN ISO 11137-2:2007 - Sterilization of health care products. Radiation. Establishing the sterilization dose. 상세보기
BS EN ISO 11137-2:2012 - Sterilization of health care Products. Radiation. Establishing the sterilization dose. 상세보기
BS EN ISO 11137-2:2013 - Sterilization of health care products. Radiation. Establishing the sterilization dose. 상세보기
BS EN ISO 11137-1:2006+A1:2013 - Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices. 상세보기
ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products 상세보기
BS EN ISO 17664:2017 - Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. 상세보기
ASTM F1140/F1140M-13(2020)e1 - Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages 상세보기
ASTM F899-20 - Standard Specification for Wrought Stainless Steels for Surgical Instruments 상세보기
ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) 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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