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医疗保健产品灭菌 确认和常规控制要求 工业湿热灭菌 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization
发布日期: 2000-12-13
实施日期: 2001-05-01
废止日期: 2017-01-01
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相似标准/计划/法规
现行
GB 18280-2000
医疗保健产品灭菌确认和常规控制要求辐射灭菌
Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
2000-12-13
现行
AAMI ST1134-93
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization
保健产品的灭菌.验证和常规控制要求.工业湿热灭菌
1993-12-01
现行
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
医疗保健产品的消毒 辐射
2019-11-27
现行
BS PD ISO/TS 22421-2021
Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
医疗保健产品的消毒 医疗设施医疗器械终端灭菌用灭菌器的通用要求
2021-01-26
现行
ISO/TS 22421-2021
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
保健品灭菌 医疗机构医疗器械终端灭菌用消毒器通用要求
2021-01-25
现行
BS EN ISO 20857-2013
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 干热 医疗器械灭菌过程的开发、验证和常规控制要求
2013-04-30
现行
BS EN ISO 11135-2014+A1-2019
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗产品的消毒 环氧乙烷 医疗器械灭菌过程的开发、验证和常规控制要求
2020-01-15
现行
BS EN ISO 17665-1-2006
Sterilization of health care products. Moist heat-Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 湿热
2006-09-29
现行
KS P ISO 11135
의료제품의 멸균 — 산화에틸렌 — 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健产品的灭菌 - 环氧乙烷 - 用于医疗器械灭菌过程的开发 验证和日常控制的要求
2018-11-05
现行
ISO 11135-2014
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
保健产品的灭菌 - 环氧乙烷 - 用于医疗器械灭菌过程的开发 验证和日常控制的要求
2014-07-07
现行
ISO 17665-2024
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
卫生保健产品灭菌湿热医疗器械灭菌过程的开发、验证和常规控制要求
2024-03-01
现行
KS P ISO 11135
의료제품의 멸균 ─ 산화에틸렌 ─ 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健品灭菌─ 环氧乙烷─ 医疗器械灭菌过程的开发、验证和常规控制要求
2022-12-28
现行
AAMI/ISO 20857-2010/(R)2015
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.干热.医疗器械灭菌过程的开发、验证和常规控制要求
2010-12-08
现行
GOST ISO 11135-2017
Стерилизация медицинской продукции. Этиленоксид. Требования к разработке, валидации и текущему управлению процессом стерилизации медицинских изделий
保健产品的灭菌 环氧乙烷 医疗器械灭菌过程的开发 验证和常规控制的要求
2017-06-01
现行
AAMI/ISO 11135-2014
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.环氧乙烷.医疗器械灭菌过程的开发、验证和常规控制要求
2015-07-27
现行
ISO 20857-2010
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
保健品灭菌——干热;医疗器械灭菌过程的开发、验证和常规控制要求
2010-08-17
现行
BS EN ISO 11737-2-2020
Sterilization of health care products. Microbiological methods-Tests of sterility performed in the definition, validation and maintenance of a sterilization process
医疗保健产品的消毒 微生物学方法
2020-05-19
现行
BS EN ISO 14937-2009
Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 医疗器械用杀菌剂的特性、杀菌过程的开发、验证和常规控制的一般要求
2010-03-31
现行
KS P ISO 14937
의료용품의 멸균 — 의료기기용 멸균제 특성 분석 및 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 일반 요구사항
保健产品的灭菌 - 杀菌剂的一般要求以及医疗器械灭菌过程的开发 验证和日常控制
2018-11-05
现行
KS P ISO 14937
의료제품의 멸균 — 의료기기용 멸균제 특성 분석과 멸균 공정의 개발, 유효성 확인, 일상관리에 대한 일반 요구사항
卫生保健产品灭菌.灭菌剂特性和医疗器械灭菌过程的开发、验证和常规控制的一般要求
2023-12-28