YY/T 0679-2016 医用低温蒸汽甲醛灭菌器
YY 0679-2008 医用低温蒸汽甲醛灭菌器
本标准规定了医用低温蒸汽甲醛灭菌器的术语和定义、型式与标记、要求、试验方法、检验规则、标志和使用说明书、包装、运输、贮存。 本标准规定的灭菌器主要利用低温蒸汽甲醛混合气体对热敏医疗物品进行灭菌。 本标准未涉及低温蒸汽甲醛灭菌过程的有效性确认和日常质量控制要求，但本标准中的测试方法和设备可参考用于
Sterilizers for medical purposes.Low temperature steam and formaldehyde sterilizers
BS EN 14180:2003+A2:2009 医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
BS EN 14180:2014 医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
BS EN 14180:2003 医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
NF S98-012:2009 医用灭菌器.低温蒸汽和甲醛灭菌器.试验和要求
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
NF S98-012*NF EN 14180:2014 医用灭菌器.低温蒸汽和甲醛灭菌器.试验和要求
La présente Norme européenne spécifie les exigences et les essais relatifs aux stérilisateurs à la vapeur et au formaldéhyde à basse température
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
WS/T 649-2019 医用低温蒸汽甲醛灭菌器卫生要求
GOST EN 14180-2011 医学用途灭菌器.低温蒸汽和甲醛灭菌器.试验和要求
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests
DIN EN 14180:2014 医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验.德文版本EN 14180-2014
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
EN 14180:2003 医用灭菌器.低温蒸汽和甲醛灭菌器的要求和试验;包含修改件A2: 2009
This European Standard specifies requirements and tests for LTSF sterilizers; which use a mixture of low temperature steam and formaldehyde
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Incorporates Amendment A2: 2009
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
DIN EN 14180:2010 医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验.德文版本EN 14180-2003+A2-2009
This standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009
NF S98-012/IN2:2009 医疗用消毒器.低温蒸汽甲醛灭菌器.要求和试验
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
YY/T 1464-2016 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求
适用 本标准规定了医疗器械低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。 本标准适用于过程开发者、灭菌设备制造商、被灭菌的医疗器械制造商和负责医疗器械灭菌的单位进行医疗器械的灭菌(见GB/T 19974 - 2005中表E.1)。 本标准覆盖了使用混合低温蒸汽甲醛作为灭菌剂、仅在低于
Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
EN ISO 25424:2019 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
1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
YY/T 1464-2022 医疗保健产品灭菌 低温蒸汽甲醛 医疗器械灭菌过程的开发、确认和常规控制要求
本文件规定了医疗器械低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。本文件适用于在负压条件下使用混合低温蒸汽甲醛作为灭菌因子的灭菌过程。本文件不适用于对海绵状脑病(如羊痒症、牛海绵状脑病和克雅症)病原体灭活过程的开发、确认和常规控制的要求
KS P ISO 25424:2020 医疗保健产品的灭菌.低温蒸汽和甲醛.医疗器械灭菌过程的开发、验证和常规控制要求
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 25424:2019/prA1:2021 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 包含修改件prA1,2021
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)
EN ISO 25424:2019/A1:2022 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 包含修改件A1,2022
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
ISO 25424:2018/Amd 1:2022 医疗保健产品的灭菌.低温蒸汽和甲醛.医疗器械灭菌过程的开发、验证和常规控制要求.修改件1
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
DIN 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(ISO 25424-2009);德文版本EN ISO 25424-2011
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009); German version EN ISO 25424:2011
ANSI/AAMI/ISO 11138-5:2006 医疗保健产品灭菌.生物指示器.第5部分:甲醛溶液灭菌处理用生物指示器
Provides specific requirements for test organisms, inoculated carriers and biological indicators intended for use in assessing the performance
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
NF S98-004-5:2006 医疗保健产品灭菌.生物指示器.第5部分:低温蒸汽和甲醛溶液灭菌处理用生物指示器
Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes.
ISO 11138-5:2006 医疗保健产品灭菌.生物指示器.第5部分:低温蒸汽和甲醛溶液灭菌处理用生物指示器
This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
DIN EN ISO 11138-5 Berichtigung 1:2007 医疗保健产品灭菌.生物指示器.第5部分:低温蒸汽和甲醛溶液灭菌处理用生物指示器(ISO 11138-5:2006)
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006, Corrigenda to DIN EN ISO 11138-5:2006-
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
T/FDSA 023-2021 低温蒸汽甲醛灭菌指示包装袋通用技术标准
GB/T 451.2 纸和纸板定量的测定 GB/T 14233.2-2005 医用输液、输血、注射器具检验方法 GB 18282.1-2015 医疗保健产品灭菌 WS/T 649 医用低温蒸汽甲醛灭菌器卫生要求
General technical criteria of instruction bags for formaldehyde sterilization
YY/T 1464-2016 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求
适用 本标准规定了医疗器械低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。 本标准适用于过程开发者、灭菌设备制造商、被灭菌的医疗器械制造商和负责医疗器械灭菌的单位进行医疗器械的灭菌(见GB/T 19974 - 2005中表E.1)。 本标准覆盖了使用混合低温蒸汽甲醛作为灭菌剂、仅在低于
Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
WS/T 651-2019 医用低温蒸汽甲醛灭菌指示物评价要求
编辑：北检院编辑部
