
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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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
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
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
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
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
本标准适用于≥0.2m3压力蒸汽灭菌器灭菌效果的检验,该检验方法必须使用生物指示剂进行
Inspecting method for sterilizing effect of automated autoclave sterilizer
Covers dimensional, constructional, and safety requirements for steam- and electrically heated, manually operated medium-vacuum sterilizers
Manually operated medium-vacuum sterilizers (autoclaves)
Inspecting method for sterilizing effect of automated autoclave sterilizer
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
Table-top steam sterilizers
本标准规定了预真空压力蒸汽灭菌器的术语、产品分类、试验方法、检验规则、标志、包装、运输和贮存的要求。 本标准适用于带抽真空系统的预真空压力蒸汽灭菌器,该产品供医疗单位作敷料织物、手术器械、医用液体等灭菌用,也可供药厂、生物制品和生物医学研究机构灭菌用
Forevacuum pressure steam sterilizer
Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015
本标准规定了脉动真空压力蒸汽灭菌器的术语、产品分类、技术要求、试验方法、检验规则及标志、包装、运输和贮存的要求。 本标准适用于带抽真空系统的脉动真空压力蒸汽灭菌器。该产品供医疗单位作敷料织物、手术器械,医用液体等灭菌用,也可供药厂、生物制品和生物医学研究机构灭菌用
Pulse vacuum pressure steam sterilizer
Sterilization of health care products - Chemical indicators - Part 4 : class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration.
本标准规定了热风循环灭菌柜的分类和标记、要求、试验方法、检验规则及标志、使用说明书、包装、运输和储存。 本标准适用于物品灭菌去热原的热风循环灭菌柜(以下简称"灭菌柜
Hot-air circulation sterilzing cabinet
本标准适用于≥0.2m3压力蒸汽灭菌器灭菌效果的检验,该检验方法必须使用生物指示剂进行
Inspecting method for sterilizing effect of automated autoclave sterilizer
Covers functional and constructional requirements for automatic sterilizers (vacuum and steam type) that may be used in hospitals, in conjunction
High-pressure high-vacuum steam sterilizers (autoclaves)
This Part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use in assessing the performance
Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
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
Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat 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 4: Biological indicators for dry heat sterilization processes
Inspecting method for sterilizing effect of automated autoclave sterilizer
1 This European Standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
Ethylene oxide gas sterilizers for medical use(small size)
この規格は,医療器具の滅菌に用いる酸化エチレンガス滅菌器(以下,滅菌器という。)のうち,最高使用圧力が,0.2MPa{2.0 kgf/cm2}未満で,かつ,内容積100リットル未満の圧力容器をもつ自動操作式のものについて規定する
Ethylene oxide gas sterilizers for medical use (small size)
1.1 This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care
Sterilization - Steam sterilizers - Large sterilizers (includes Amendment A2:2009); English version of DIN EN 285:2009-08
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
This specification covers dimensional, constructional, and safety requirements for steam- and electrically heated, manually operated medium-vacuum
Manually operated medium-vacuum sterilizers (autoclaves)








