干热灭菌是使用干热空气作为灭菌剂的灭菌过程。一种使用干热对医疗器械进行灭菌的过程,利用高温干热对医疗器械进行灭菌的过程,通过热空气对流实现微生物灭活。
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| ANSI/AAMI ST40-2004(2018) 指南标准 |
Dry heat (heated air) sterilization of dials and sterility assurance in healthcare settings
灭菌保证水平 |
2018 美国国家标准学会 |
| ANSI/AAMI/ISO 11138-4:2017 试验标准 |
Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
生物指示剂 |
2017 美国国家标准学会 |
| ANSI/AAMI/ISO 20857:2010(2015) 规范标准 |
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
|
2015-12-11 美国国家标准学会 |
| ANSI/ADA AAMI ST40-2004(2013) 指南标准 |
Table Dry Heat (Heated Air) Sterilization and Sterility Assurance in Healthcare Facilities
化学指示剂 生物指示剂 |
2013 美国国家标准学会 |
| BS EN ISO 11138-4:2017 试验标准 |
Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
测试生物体 生物指示剂 |
2017-04-30 英国标准学会 |
| BS EN ISO 20857:2013 规范标准 |
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
|
2013-04-30 英国标准学会 |
| CAN/CSA-ISO 11138-4:2017 试验标准 |
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
D值 生物指示剂 |
2017 加拿大标准协会 |
| CSA ISO 20857:2019 规范标准 |
保健品灭菌 干热 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
|
2019 加拿大标准协会 |
| DIN EN ISO 11138-4:2017 试验 |
保健品灭菌-生物指示剂-第4部分:干热灭菌过程的生物指示剂(ISO 11138-4:2017);德文版 EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
生物指示剂 耐热性 |
2017-07 德国标准化学会 |
| DIN EN ISO 20857 E:2012-10 规范 |
保健品消毒 干热 医疗器材消毒步骤的制定,确认和常规控制要求(草案) Formulation, confirmation and routine control requirements for disinfection of health care products and dry heat medical equipment (draft)
无菌保证水平 |
2012-10 德国标准化学会 |
| DIN EN ISO 20857:2013 规程标准 |
保健品消毒.干热.医疗器材消毒步骤的制定,确认和常规控制要求(ISO 20857-2010).德文版本EN ISO 20857-2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
|
2013-08 德国标准化学会 |
| DIN EN ISO 20857:2013-08 规范标准 |
保健品灭菌 干热 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 (ISO 20857:2010); German version EN ISO 20857:2013
|
2013-08 德国标准化学会 |
| ISO 11138-4:2017 试验标准 |
医疗保健产品消毒. 生物指标. 第4部分: 干热灭菌过程生物指标 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
生物指示剂 |
2017-03-01 国际标准化组织 |
| ISO 20857:2010 规范标准 |
保健品消毒.干热.医疗器材消毒步骤的制定,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
|
2010-08 国际标准化组织 |
| LST EN ISO 11138-4:2017 试验 |
医疗器械的灭菌 生物指示剂 第4部分:用于干热灭菌的生物指示剂(ISO 11138-4:2017) Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
生物指示剂 |
2017-05-31 立陶宛标准局 |
| MS ISO 11138-4:2010 试验 |
医疗保健产品的灭菌 生物指示物 第4部分:干热灭菌过程用生物指示物 (ISO 11138-4:2006, IDT) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2006, IDT)
D 值 生物指示剂 |
2020-04-05 马来西亚标准 |
| PDA TR3-2013 指南标准 |
Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
|
2013-01-01 肠外药物协会 |
| SS-EN ISO 11138-4:2006 试验 |
医疗卫生产品的灭菌 生物指示物 第4部分:干热灭菌过程的生物指示物(ISO 11138-4:2006) Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006)
D 值 生物指示剂 |
2006 瑞典标准研究所 |
| SS-EN ISO 20857:2013 规范 |
医疗产品灭菌 干热 灭菌过程开发、验证和常规控制的要求(ISO 20857:2010) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
|
2013 瑞典标准研究所 |
| SS-ISO 20857:2011 规范标准 |
医疗产品灭菌 干热 灭菌过程开发、验证和常规控制的要求(ISO 20857:2010 等同采用) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010, IDT)
|
2011 瑞典标准研究所 |
| UNE-EN ISO 11138-4:2017 试验标准 |
保健品灭菌-生物指示剂-第4部分:干热灭菌过程的生物指示剂(ISO 11138-4:2017) Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
测试生物体 生物指示剂 |
2017-10-11 西班牙标准化协会 |
| UNE-EN ISO 20857:2013 规范标准 |
医疗保健产品灭菌 干热 医疗器械灭菌过程的开发、验证和常规控制要求(ISO 20857:2010) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
|
2013-11-27 西班牙标准化协会 |
| YY 1275-2016 试验 |
Dry heat (heated air) sterilizers
灭菌器 |
2016-03-23 行业标准-医药 |
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