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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
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
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
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
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
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
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
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
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
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
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
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
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)
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
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
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)
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)
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
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
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
Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes.
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
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-
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 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
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
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