法规与标准

指导文件 – 德国卫生部对清洗消毒灭菌的要求

KRINKO/BfArM Recommendations Hygiene Requirements for the Reprocessing of Medical Devices -- Recommendation from the Commission on Hospital Hygiene and Infection Protection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene requirements for the reprocessing of medical devices". Bundesgesundheitsblatt 2012 – 55:1244-1310.

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指导文件 – 德国三机构联合发表的清洗消毒确认要求

Guideline from DGKH, DGSV and AKI for the validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices.

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法令 - 欧盟指令 MDD

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

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国际标准 - 自动清洗消毒机高温消毒方法的要求

EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

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国际标准 - 自动清洗消毒机标准

EN ISO 15883-1:2009 + A1:2014 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

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指导文件 – 欧洲胃肠内窥镜学会对软性内镜的再处理要求

Reprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: PReprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) – Update 2018

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国际标准 - 清洗测试方法的要求

ISO/DIS 15883-5:2019 Washer disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy

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国际标准 - 不耐热器械（软性内镜）自动清洗消毒机要求

EN ISO 15883-4:2018 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors empEN ISO 15883-4:2018 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

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国际标准 - 蒸汽灭菌方法确认

EN ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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国际标准 - 蒸汽灭菌标准/小型灭菌器

EN 13060 Small steam sterilizers

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国际标准 - 蒸汽灭菌标准/大型灭菌器

EN 285 Sterilization - Steam sterilizers - Large sterilizers

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国际标准 - 蒸汽灭菌方法确认指导

ISO/TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1

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指导文件 – 美国 FDA

AAMI TIR30:2011 (R2016) A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

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国际标准 - 风险管理

EN ISO 14971 Medical devices – application of risk management to medical devices

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指导文件 – 美国 FDA

AAMI TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

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法规 - 欧盟法规 MDR

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

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国际标准 - 产品说明书里关于再处理方法及其测试的要求

EN ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices

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