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
UNE-EN 556-1-2002
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for terminally sterilized medical devices.
医疗器械的消毒 医疗器械被指定为“无菌”的要求 第1部分:最终灭菌医疗器械的要求
2002-02-28
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
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
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
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
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
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
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
BS EN ISO 11137-1-2015+A2-2019
Sterilization of health care products. Radiation-Requirements for development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 辐射
2019-11-27
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
AAMI/ISO 14937-2009/(R)2013
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.医疗器械用灭菌剂特性和灭菌过程的开发、验证和常规控制的一般要求
2009-10-14
KS P ISO 14937
의료용품의 멸균 — 의료기기용 멸균제 특성 분석 및 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 일반 요구사항
保健产品的灭菌 - 杀菌剂的一般要求以及医疗器械灭菌过程的开发 验证和日常控制
2018-11-05
BS EN ISO 14937-2009
Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 医疗器械用杀菌剂的特性、杀菌过程的开发、验证和常规控制的一般要求
2010-03-31
KS P ISO 14937
의료제품의 멸균 — 의료기기용 멸균제 특성 분석과 멸균 공정의 개발, 유효성 확인, 일상관리에 대한 일반 요구사항
卫生保健产品灭菌.灭菌剂特性和医疗器械灭菌过程的开发、验证和常规控制的一般要求
2023-12-28
GB/T 19974-2018
医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求
Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
2018-05-14
ISO 14937-2009
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
保健品灭菌——医疗器械用杀菌剂特性和杀菌过程的开发、验证和常规控制的一般要求
2009-10-14
AAMI/ISO 11135-2014
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
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
2015-07-27
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
KS P ISO 11135
의료제품의 멸균 — 산화에틸렌 — 의료기기용 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 요구사항
保健产品的灭菌 - 环氧乙烷 - 用于医疗器械灭菌过程的开发 验证和日常控制的要求
2018-11-05