YY 1275-2016 热空气型干热灭菌器
本标准规定了热空气型干热灭菌器的术语和定义、要求、试验方法、检验规则和标志、包装、使用说明书、运输和储存等。 本标准适用于以对流热空气为灭菌介质的干热灭菌器(以下简称灭菌器)。该灭菌器主要用于实验室、护理诊所、医院和其他医疗保健场所的医疗器械及其附件的灭菌。 本标准不适用于传导型或辐射型干热
Dry heat (heated air) sterilizers
ANSI/AAMI ST50-2004 干热(加热空气)灭菌器
Establishes minimum labeling and performance requirements for dry heat (heated air) sterilizers intended for use in dental and physicians offices
Dry heat (heated air) sterilizers
JB/T 20163-2014 药用干热灭菌器
本标准规定了药用干热灭菌器的分类和标记、要求、试验方法、检验规则,以及标志、使用说明书、包装、运输和储存。本标准适用于制药领域不宜湿热灭菌或除热原物品的药用干热灭菌器(以下简称灭菌器
Pharmaceutical dry heating sterilizer
ANSI/AAMI ST40-2004 卫生设施中台式干热(加热的空气)灭菌和菌性保证
Provides guidelines for dry heat sterilization in health care facilities. Covers functional and physical design criteria for work areas; staff
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
T/CASME 325-2023 湿热型灭菌器性能检测方法
本文件规定了湿热型灭菌器的术语和定义、性能（计时检查、温度传感器准确性、压力检查、热分布、热穿透、生物指示剂）的检测方法
Testing method for performance of moist heat sterilizer
YY/T 1263-2015 适用于干热灭菌的医疗器械的材料评价
本标准规定了材料选择、设计和加工、材料试验。为选择干热灭菌的材料适应性提供评价指南。本标准适用于采用干热灭菌的医疗器械的材料评价
Evaluation of materials of medical device subject to dry heat sterilization
ANSI/AAMI/ISO 11138-4:2006 医疗保健产品灭菌.生物指示器.第4部分:干热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 4: Biological indicators for dry heat sterilization processes
NF S98-004-4:2006 医疗保健产品灭菌.生物指示器.第4部分:干热灭菌处理用生物指示器
Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes.
ISO 11138-4:2006 医疗保健产品灭菌.生物指示器.第4部分:干热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 4: Biological indicators for dry heat sterilization processes
BS EN ISO 20857:2013 保健品灭菌.干热法.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. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11138-4:2017 医疗保健产品灭菌.生物指示物.干热灭菌用生物指示剂
Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
BS EN ISO 11138-4:2006 医疗保健产品灭菌.生物指示物.干热灭菌用生物指示剂
ISO 11138-4:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended
Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes
YY 0602-2007 测量、控制和试验室用电气设备的安全使用热空气或热惰性气体处理医用材料及供试验室用的干热灭菌器的特殊要求
1 范围和目的 除下述内容外，GB 4793.1的本章适用 1．1 范围 代替： 本标准适用于一切包括带自动装载和卸载系统的灭菌器，它们有一个或多个灭菌室，采用热空气或 热惰性气体，在接近于大气压力下运行，拟用于处理医用材料及供试验室处理使用 注1
Safety requirements for electrical equipment for measurement,control, and laboratory use-Part 2-043:Particular requirements for bry heat sterilizers using either hot air or hot inert gas for the treeatment of medical materials,and for laboratory processes
NF S98-104*NF EN ISO 20857:2013 医疗保健产品灭菌 - 干热 - 医疗器械灭菌过程的设计, 确认和常规控制要求
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
T/CSPSTC 48-2020 室内等离子空气灭菌器
使用室内等离子空气灭菌器可以保持室内生活空间的健康、清洁，该灭菌器可应用于家居、办公室、医院、学校、公共场所、汽车、运输系统（如火车和飞机）等室内环境中。室内等离子空气灭菌器需耗材、耗电量低，且能够高效
Indoor plasma air sanitization device
YY 1275-2016 热空气型干热灭菌器
本标准规定了热空气型干热灭菌器的术语和定义、要求、试验方法、检验规则和标志、包装、使用说明书、运输和储存等。 本标准适用于以对流热空气为灭菌介质的干热灭菌器(以下简称灭菌器)。该灭菌器主要用于实验室、护理诊所、医院和其他医疗保健场所的医疗器械及其附件的灭菌。 本标准不适用于传导型或辐射型干热
Dry heat (heated air) sterilizers
ANSI/AAMI ST50-2004 干热(加热空气)灭菌器
Establishes minimum labeling and performance requirements for dry heat (heated air) sterilizers intended for use in dental and physicians offices
Dry heat (heated air) sterilizers
JB/T 20163-2014 药用干热灭菌器
本标准规定了药用干热灭菌器的分类和标记、要求、试验方法、检验规则,以及标志、使用说明书、包装、运输和储存。本标准适用于制药领域不宜湿热灭菌或除热原物品的药用干热灭菌器(以下简称灭菌器
Pharmaceutical dry heating sterilizer
ANSI/AAMI ST40-2004 卫生设施中台式干热(加热的空气)灭菌和菌性保证
Provides guidelines for dry heat sterilization in health care facilities. Covers functional and physical design criteria for work areas; staff
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
T/CASME 325-2023 湿热型灭菌器性能检测方法
本文件规定了湿热型灭菌器的术语和定义、性能（计时检查、温度传感器准确性、压力检查、热分布、热穿透、生物指示剂）的检测方法
Testing method for performance of moist heat sterilizer
YY/T 1263-2015 适用于干热灭菌的医疗器械的材料评价
本标准规定了材料选择、设计和加工、材料试验。为选择干热灭菌的材料适应性提供评价指南。本标准适用于采用干热灭菌的医疗器械的材料评价
Evaluation of materials of medical device subject to dry heat sterilization
ANSI/AAMI/ISO 11138-4:2006 医疗保健产品灭菌.生物指示器.第4部分:干热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 4: Biological indicators for dry heat sterilization processes
NF S98-004-4:2006 医疗保健产品灭菌.生物指示器.第4部分:干热灭菌处理用生物指示器
Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes.
ISO 11138-4:2006 医疗保健产品灭菌.生物指示器.第4部分:干热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 4: Biological indicators for dry heat sterilization processes
BS EN ISO 20857:2013 保健品灭菌.干热法.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. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11138-4:2017 医疗保健产品灭菌.生物指示物.干热灭菌用生物指示剂
Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
BS EN ISO 11138-4:2006 医疗保健产品灭菌.生物指示物.干热灭菌用生物指示剂
ISO 11138-4:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended
Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes
YY 0602-2007 测量、控制和试验室用电气设备的安全使用热空气或热惰性气体处理医用材料及供试验室用的干热灭菌器的特殊要求
1 范围和目的 除下述内容外，GB 4793.1的本章适用 1．1 范围 代替： 本标准适用于一切包括带自动装载和卸载系统的灭菌器，它们有一个或多个灭菌室，采用热空气或 热惰性气体，在接近于大气压力下运行，拟用于处理医用材料及供试验室处理使用 注1
Safety requirements for electrical equipment for measurement,control, and laboratory use-Part 2-043:Particular requirements for bry heat sterilizers using either hot air or hot inert gas for the treeatment of medical materials,and for laboratory processes
NF S98-104*NF EN ISO 20857:2013 医疗保健产品灭菌 - 干热 - 医疗器械灭菌过程的设计, 确认和常规控制要求
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
T/CSPSTC 48-2020 室内等离子空气灭菌器
使用室内等离子空气灭菌器可以保持室内生活空间的健康、清洁，该灭菌器可应用于家居、办公室、医院、学校、公共场所、汽车、运输系统（如火车和飞机）等室内环境中。室内等离子空气灭菌器需耗材、耗电量低，且能够高效
Indoor plasma air sanitization device
编辑：北检院编辑部
