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Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'STERILE'. NOTE. For the purposes
Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
本标准规定了医疗器械制造商应提供的关于可重复灭菌医疗器械与预期由处理者灭菌医疗器械的再处理信息。 本标准规定了制造商提供的处理信息的要求，以确保医疗器械的被安全处理，并持续满足其性能要求。 本标准规定了以下所有或某些处理过程的要求： -使用后的现场准备； -准备，清洗，消毒； -干燥
Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
Sterilising Medical instruments Set
Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices
This European Standard specifies the requirements for an aseptically processed medical deviceto be designated 'STERILE'.NOTE ForThe purpose
Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose
"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
Packaging for terminally sterilized medical devices
Packaging for terminally sterilized medical devices
Packaging for terminally sterilized medical devices
Packaging for terminally sterilized medical devices
Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
Evaluating method for the efficacy of sterilization for disinfection equipment
YY/T 0615的本部分规定了标示“ 菌”最终灭菌医疗器械的要求。YY/T 0615第2部分规定了标示“ 菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“ 菌”.GB 18278、GB 18279、GB 18280、GB/T 19974、ISO
Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
This European Standard specifies requirements for the development, validation and routine control ofa Low Temperature Steam and Formaldehyde (LTSF
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
General requirements of disinfectant of medical instruments
本标准规定了医疗器械消毒剂的技术要求、试验方法、使用方法、标志、标签和说明书及注意事项。 本标准适用于医疗器械消毒、灭菌用消毒剂。 本标准不适用于带消毒因子发生装置的消毒器械及气体类或在特定条件下气化后发挥作用的消毒、灭菌产品
Hygienic requirements for medical items disinfection
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015
This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
The General Services Administration has authorized the use of this Commercial Item Description
STERILIZER, SURGICAL INSTRUMENT AND DRESSING (AUTOCLAVE)
本文件规定了机器人手术器械的清洗消毒、检查包装操作流程及灭菌方法。 本文件适用于各类医疗机构对微创外科手术机器人手术器械的清洗消毒、检查包装和灭菌
Cleaning, disinfection and sterilization of robotic surgical instruments
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