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热空气型干热灭菌器检测

发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22

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军工检测 其他检测

YY 1275-2016

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 (加)

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

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(加)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 适用于的医疗械的材料评价

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.生物指示.第4部分:处理用生物指示

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.生物指示.第4部分:处理用生物指示

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.生物指示.第4部分:处理用生物指示

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.法.医疗过程的开发,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.生物指示物.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.生物指示物.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、控制和试验室用电设备的安全使用惰性体处理医用材料及供试验室用的的特殊要求

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 - - 医疗过程的设计, 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

        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

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 (加)

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

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(加)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 适用于的医疗械的材料评价

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.生物指示.第4部分:处理用生物指示

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.生物指示.第4部分:处理用生物指示

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.生物指示.第4部分:处理用生物指示

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.法.医疗过程的开发,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.生物指示物.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.生物指示物.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、控制和试验室用电设备的安全使用惰性体处理医用材料及供试验室用的的特殊要求

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 - - 医疗过程的设计, 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

        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

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