现行

YY 1275-2016

热空气型干热灭菌器
Dry heat (heated air) sterilizers

2016-03-23

现行

AAMI ST50-2004/(R)2018

Dry Heat (Heated Air) Sterilizers
干热（热空气）灭菌器

2004-04-07

现行

CID A-A-50899

STERILIZER, DRY HEAT (NO S/S DOCUMENT)
干热灭菌器（无S/S文件）

1985-12-30

现行

CID A-A-50899

STERILIZER, DRY HEAT (NO S/S DOCUMENT)
干热灭菌器（无S/S文件）

1985-12-30

现行

ADA ST40-2004(R2010)

Table-top Dry Heat (heated air) Sterilization and Sterility Assurance in Health Care Facilities
医疗设施中的台式干热（热空气）灭菌和无菌保证

现行

YY/T 1263-2015

适用于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

2015-03-02

现行

DOXPUB 11-0007-SOP

Operation and Maintenance of The Lytzen Class 100 Dry Heat Sterilizer
Lytzen 100型干热灭菌器的使用与维护

2007-08-01

现行

BS EN ISO 11138-4-2017

Sterilization of health care products. Biological indicators-Biological indicators for dry heat sterilization processes
医疗保健产品的消毒 生物指标

2017-04-30

现行

GB 18281.4-2015

医疗保健产品灭菌　生物指示物　第4部分：干热灭菌用生物指示物
Sterilization of health care products—Biological indicators—Part 4:Biological indicators for dry heat sterilization processes

2015-12-10

现行

ISO 11138-4-2017

Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
保健产品的灭菌 - 生物指示器 - 第4部分:干热灭菌过程的生物指标

2017-03-03

现行

AAMI/ISO 11138-4-2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
医疗保健产品的灭菌.生物指示剂.第4部分:干热灭菌过程用生物指示剂

2017-08-01

现行

GOST R ISO 20857-2016

Стерилизация медицинской продукции. Горячий воздух. Требования к разработке, валидации и текущему контролю процесса стерилизации медицинских изделий
医疗器械灭菌干热 对医疗器械灭菌过程的开发 验证和常规控制的要求

现行

BS 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
医疗保健产品的消毒 干热 医疗器械灭菌过程的开发、验证和常规控制要求

2013-04-30

现行

AAMI/ISO 20857-2010/(R)2015

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.干热.医疗器械灭菌过程的开发、验证和常规控制要求

2010-12-08

现行

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
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

2010-08-17

现行

YY/T 1276-2016

医疗器械干热灭菌过程的开发、确认和常规控制要求
Requirements for the development,validation and routine control of dry heat sterilization process for medical devices

2016-03-23

现行

AAMI ST40-2004/(R)2018

Periodic review of ANSI/AAMI ST40:2004, Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities (Reaffirmed 2010)
定期审查ANSI/AAMI ST40:2004《医疗设施中的台式干热（加热空气）灭菌和无菌保证》（2010年重申）

2004-10-07

现行

BS 07/30164697 DC

ISO 20857. Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices
ISO 20857 医疗保健产品的消毒 干热 医疗器械工业灭菌过程的开发、验证和常规控制要求

2007-04-12

现行

UNE-EN ISO 11138-4-2007

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006)
医疗保健产品的灭菌.生物指示剂.第4部分:干热灭菌过程用生物指示剂（ISO 11138-4-2006）

2007-05-16

现行

PDA TR 30

Technical Report 30 Revised 2012, (TR 30) Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat
2012年修订的技术报告30 （TR 30）湿热灭菌药品和医疗器械产品的参数放行

2012-05-01