现行

BS EN 556-2-2015

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Requirements for aseptically processed medical devices
医疗器械的消毒 指定为“无菌”医疗器械的要求

2015-09-30

现行

GOST EN 556-1-2011

Стерилизация медицинских изделий. Требования к медицинским изделиям категории «стерильные». Часть 1. Требования к медицинским изделиям, подлежащим финишной стерилизации
医疗器械灭菌医疗器械要求被指定为“无菌” 第一部分终末消毒医疗器械的要求

2011-11-29

现行

UNE-EN 556-2-2004

Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
医疗器械的灭菌.指定无菌医疗器械的要求.第2部分:无菌处理医疗器械的要求

2004-06-25

现行

YY/T 0615.1-2007

标示"无菌"医疗器械的要求　第1部分:最终灭菌医疗器械的要求
Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices

2007-07-02

现行

DIN EN 13824

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
医疗器械的灭菌.液体医疗器械的无菌处理.要求；德文版EN 13824:2004

2005-02-01

现行

UNE-EN 13824-2005

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
医疗器械的灭菌.液体医疗器械的无菌处理.要求

2005-05-25

现行

DIN EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; English version of DIN EN 556-1
医疗器械的灭菌.指定为“无菌”的医疗器械的要求.第1部分:最终灭菌医疗器械的要求；德文版EN 556-1:2001

2002-03-01

现行

YY/T 0615.2-2007

标示“无菌”医疗器械的要求　第2部分:无菌加工医疗器械的要求
Requirements for medical devices to be designated "STERILE"—Part 2:Requirements for aseptically processed medical devices

2007-07-02

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

AAMI ST77-2013/(R)2018

Containment devices for reusable medical device sterilization
可重复使用医疗器械灭菌用密闭装置

2013-02-01

现行

GOST R ISO 17664-2012

Стерилизация медицинских изделий. Информация, предоставляемая изготовителем для проведения повторной стерилизации медицинских изделий
医疗器械灭菌由制造商提供的用于处理可再次消毒的医疗设备的信息

现行

DIN EN 15424

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
医疗器械灭菌-低温蒸汽和甲醛-医疗器械灭菌过程的开发、验证和常规控制要求；德文版EN 15424:2007

2007-08-01

现行

UNE-EN 15424-2007

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
医疗器械的灭菌.低温蒸汽和甲醛.医疗器械灭菌过程的开发、验证和常规控制要求

2007-09-26

现行

GOST R ISO 25424-2013

Стерилизация медицинских изделий. Стерилизация низкотемпературная пароформальдегидная. Требования к разработке, валидации и рутинному контролю процесса стерилизации
医疗器械灭菌低温蒸汽和甲醛 对医疗器械灭菌过程的开发 验证和常规控制的要求

现行

SN/T 3062.4-2011

进口医疗器械灭菌包装 第4部分：材料和预成型无菌屏障系统要求
Packaging materials for terminally sterilized medical devices for import-Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging

2011-09-09

现行

BS EN 868-2-2017

Packaging for terminally sterilized medical devices-Sterilization wrap. Requirements and test methods
最终灭菌医疗器械的包装

2017-02-28

现行

YY/T 1613-2018

医疗器械辐照灭菌过程特征及控制要求
Requirements for process characterization and control in radiation sterilization of medical devices

2018-09-29

现行

GOST ISO 10993-7-2016

Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 7. Остаточное содержание этиленоксида после стерилизации
医疗设备 医疗器械生物学评价 环氧乙烷灭菌残留物

2016-10-25

现行

CAN/CSA Z314.4-87

Industrial Sterilization of Medical Devices by the Steam Process
医疗器械的蒸汽灭菌

1987-01-01

现行

YY/T 0033-2000

无菌医疗器具生产管理规范
Good manufacture practice for sterile medical devices

2000-08-18