GOST EN 556-1-2011 医疗器械的消毒.标明为"菌"的医疗器械的要求.第1部分:医疗器械最终灭菌的要求
Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
GOST R ISO 17664-2012 医疗器械的灭菌. 由制造商提供的可再消毒医疗器械处理信息
Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
YY/T 1478-2016 可重复使用医疗器械消毒灭菌的追溯信息
DIN EN 556-2:2004 医疗器械的消毒.标有"消毒"字样的医疗器械的要求.第2部分:经菌处理的医疗器械的要求
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
NF S98-107-2:2004 医疗器械的消毒.对标有"消毒"字样的医疗器械的要求.第2部分:经菌处理的医疗器械的要求
"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
DS/EN 556:1995 医疗器械的消毒．标上“已消毒”标签的医疗器械的要求
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"
YY/T 0802-2010 医疗器械的灭菌 制造商提供的处理可重复灭菌医疗器械的信息
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
AS/NZS 4815 Set-2008 消毒医疗器械（全套）
Sterilising Medical instruments Set
TIS 2278-2006 医疗器械灭菌.制造商提供的可重复灭菌医疗器械处置信息
Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices
EN 556-2:2003 医疗器械的消毒.标明为"消过毒"的医疗器械的要求.第2部分:消毒处理的医疗器械的要求
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
EN 556-2:2015 医疗器械的消毒.标明为 消过毒 的医疗器械的要求.第2部分:消毒处理的医疗器械的要求
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"
NF S98-136:2009 医疗器械消毒.医疗机构消毒医疗器械预备工作的相关风险管理
Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
T/SHBX 005-2023 《可灭菌医疗器械包装膜》
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
KS P ISO 11607:2002 封装终端灭菌医疗器械
Packaging for terminally sterilized medical devices
KS P ISO 11607:2007 封装终端灭菌医疗器械
Packaging for terminally sterilized medical devices
KS P ISO 11607:2002 封装终端灭菌医疗器械
Packaging for terminally sterilized medical devices
KS P ISO 11607:2007 封装终端灭菌医疗器械
Packaging for terminally sterilized medical devices
NF S98-107-1*NF EN 556-1:2002 医疗器械的消毒 对要标明"已消毒"字样的医疗器械的要求 第1部分：定期消毒的医疗器械要求
Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices
GB/T 19633-2005 最终灭菌医疗器械的包装
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
GOST R ISO 25424-2013 医疗器械的灭菌. 低温蒸汽和甲醛医疗器械消毒方法的制定, 确认和常规控制要求
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
GB/T 15981-2021 消毒器械灭菌效果评价方法
Evaluating method for the efficacy of sterilization for disinfection equipment
YY/T 0615.1-2007 标示“菌”医疗器械的要求 第l部分：最终灭菌医疗器械的要求
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
EN ISO 25424:2011 医疗器械的灭菌.低温蒸汽和甲醛.医疗器械灭菌过程的开发,确认和常规控制要求医疗器械的灭菌.低温蒸汽和甲醛.医疗器械灭菌过程的开发,确认和常规控制要求医疗器械的
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
BS EN ISO 17664:2004 医疗器械的消毒.生产商提供的可再消毒医疗器械的处理信息
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
GB 27949-2020 医疗器械消毒剂通用要求
General requirements of disinfectant of medical instruments
GB/T 27949-2011 医疗器械消毒剂卫生要求
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
DIN EN 556-2:2015 医疗器械的消毒.标有"消毒"字样的医疗器械的要求.第2部分:经菌处理的医疗器械的要求;德文版本EN 556-2-2015
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
ISO 17664:2004 医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息
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
DOD A-A-54708-1992 外科器械和敷料消毒器(高压灭菌器)
The General Services Administration has authorized the use of this Commercial Item Description
STERILIZER, SURGICAL INSTRUMENT AND DRESSING (AUTOCLAVE)
T/CAME 51-2022 机器人手术器械清洗消毒及灭菌
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
编辑：北检院编辑部
