YY 0503-2016 环氧乙烷灭菌器
YY 0503-2005 环氧乙烷灭菌器
本标准规定了环氧乙烷灭菌器的术语和定义、分类与标记、要求、试验方法、检验规则、标志、使用说明书和包装、运输、贮存。 本标准适用于最高工作压力低于0.1MPa、采用纯环氧乙烷气体或采用环氧乙烷与其他气体混合的环氧乙烷灭菌器(以下简称灭菌器)。该灭菌器供工业生产灭菌和医用灭菌用
Ethylene oxide sterilizer
T/ZZB 2701-2022 工业用环氧乙烷灭菌器
本文件规定了工业用环氧乙烷灭菌器的术语和定义、分类与标记、基本要求、技术要求、试验方法、检验规则、标志、使用说明书和包装、运输、贮存、报废处理、质量承诺。 本文件适用于最高工作压力低于100 kPa、采用环氧乙烷液化气体灭菌的工业用环氧乙烷灭菌器(以下简称灭菌器)。该灭菌器容积
Industrial ethvlene oxide sterilizer
LST EN 1422-2014 医用灭菌器. 环氧乙烷灭菌器. 要求和试验方法
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
NF S98-015/IN1:2009 医用灭菌器.环氧乙烷灭菌器.试验方法和要求
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
EN 1422:2014 医用环氧乙烷灭菌器.灭菌器.要求和试验方法
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
DIN EN 1422:2014 医用灭菌器.环氧乙烷灭菌器.要求和试验方法;德文版本EN 1422-2014
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
EN 1422:1997 医用灭菌器.环氧乙烷灭菌器.要求和试验方法;包含修改件A1: 2009
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 Incorporates Amendment A1: 2009
KS P 6115-2021 医用环氧乙烷气体灭菌器
Ethylene oxide gas sterilizers for medical use
ANSI/AAMI ST24-1999 卫生保健机构用一般用途的环氧乙烷自动灭菌器和环氧乙烷菌源
Covers minimum labeling, safety, performance and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use
Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
KS P 6116-2021 医用环氧乙烷气体灭菌器（小型）
Ethylene oxide gas sterilizers for medical use(small size)
SANS 10213-2008 医疗设施及工业用环氧乙烷(EO)灭菌器的安装及安全使用
Covers the procedure for the installation of ethylene oxide (EO) sterilizers and the safety precautions and system management necessary for the safe
The installation and safe use of ethylene oxide (EO) sterilizers in healthcare facilities and in industry
ISO/DIS 11135:2023 医疗保健产品的灭菌.环氧乙烷.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 - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
T/CAMDI 056-2020 菌医疗器械环氧乙烷灭菌过程管理规范
本文件从质量管理体系、安全和环境保护、灭菌过程控制和监视、变更和不合格控制以及重新灭菌等方面，对环氧乙烷灭菌生产过程控制提出了明确要求和指导，用于指导自行灭菌的医疗器械制造商和分包灭菌商，以规范环氧乙烷灭菌过程的管理。本规范文件中除适用范围、规范性引用文件、术语和定义及参考文献部分外，其它部分的
Ethylene oxide sterilization process practice of sterile medical device
YY/T 1267-2015 适用于环氧乙烷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。为选择环氧乙烷灭菌的材料适应性提供评价指南。 本标准适用于采用环氧乙烷灭菌的医疗器械的材料评价
Evaluation of materials of medical device subject to ethylene oxide sterilization
YY 0503-2016 环氧乙烷灭菌器
YY 0503-2005 环氧乙烷灭菌器
本标准规定了环氧乙烷灭菌器的术语和定义、分类与标记、要求、试验方法、检验规则、标志、使用说明书和包装、运输、贮存。 本标准适用于最高工作压力低于0.1MPa、采用纯环氧乙烷气体或采用环氧乙烷与其他气体混合的环氧乙烷灭菌器(以下简称灭菌器)。该灭菌器供工业生产灭菌和医用灭菌用
Ethylene oxide sterilizer
T/ZZB 2701-2022 工业用环氧乙烷灭菌器
本文件规定了工业用环氧乙烷灭菌器的术语和定义、分类与标记、基本要求、技术要求、试验方法、检验规则、标志、使用说明书和包装、运输、贮存、报废处理、质量承诺。 本文件适用于最高工作压力低于100 kPa、采用环氧乙烷液化气体灭菌的工业用环氧乙烷灭菌器(以下简称灭菌器)。该灭菌器容积
Industrial ethvlene oxide sterilizer
LST EN 1422-2014 医用灭菌器. 环氧乙烷灭菌器. 要求和试验方法
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
NF S98-015/IN1:2009 医用灭菌器.环氧乙烷灭菌器.试验方法和要求
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.
EN 1422:2014 医用环氧乙烷灭菌器.灭菌器.要求和试验方法
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
DIN EN 1422:2014 医用灭菌器.环氧乙烷灭菌器.要求和试验方法;德文版本EN 1422-2014
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods; German version EN 1422:2014
EN 1422:1997 医用灭菌器.环氧乙烷灭菌器.要求和试验方法;包含修改件A1: 2009
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 Incorporates Amendment A1: 2009
KS P 6115-2021 医用环氧乙烷气体灭菌器
Ethylene oxide gas sterilizers for medical use
ANSI/AAMI ST24-1999 卫生保健机构用一般用途的环氧乙烷自动灭菌器和环氧乙烷菌源
Covers minimum labeling, safety, performance and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use
Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
KS P 6116-2021 医用环氧乙烷气体灭菌器（小型）
Ethylene oxide gas sterilizers for medical use(small size)
SANS 10213-2008 医疗设施及工业用环氧乙烷(EO)灭菌器的安装及安全使用
Covers the procedure for the installation of ethylene oxide (EO) sterilizers and the safety precautions and system management necessary for the safe
The installation and safe use of ethylene oxide (EO) sterilizers in healthcare facilities and in industry
ISO/DIS 11135:2023 医疗保健产品的灭菌.环氧乙烷.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 - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
T/CAMDI 056-2020 菌医疗器械环氧乙烷灭菌过程管理规范
本文件从质量管理体系、安全和环境保护、灭菌过程控制和监视、变更和不合格控制以及重新灭菌等方面，对环氧乙烷灭菌生产过程控制提出了明确要求和指导，用于指导自行灭菌的医疗器械制造商和分包灭菌商，以规范环氧乙烷灭菌过程的管理。本规范文件中除适用范围、规范性引用文件、术语和定义及参考文献部分外，其它部分的
Ethylene oxide sterilization process practice of sterile medical device
YY/T 1267-2015 适用于环氧乙烷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。为选择环氧乙烷灭菌的材料适应性提供评价指南。 本标准适用于采用环氧乙烷灭菌的医疗器械的材料评价
Evaluation of materials of medical device subject to ethylene oxide sterilization
编辑：北检院编辑部
