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
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
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 0615.2-2007
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
AAMI/ISO 11607-1-2019
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
最终灭菌医疗器械的包装第1部分:材料、无菌屏障系统和包装系统的要求
KS P ISO 11607-1
최종 멸균 처리한 의료기기의 포장 — 제1부: 재료, 무균 장벽 시스템 및포장 시스템에 대한 요구사항
用于终端灭菌医疗器械的包装 - 第1部分:材料 无菌屏障系统和包装系统的要求
2018-11-05
KS P ISO 11607-1
최종 멸균 처리한 의료기기의 포장 — 제1부: 재료, 무균 장벽 시스템 및 포장 시스템에 대한 요구사항
最终灭菌医疗器械的包装.第1部分:材料、无菌屏障系统和包装系统的要求
2021-06-28
GB/T 19633.1-2015
最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
2015-12-10
ISO 11607-1-2019
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
用于终端灭菌医疗器械的包装 - 第1部分:材料 无菌屏障系统和包装系统的要求
2019-01-31
UNE-EN 1174-1-1996
STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 1: REQUIREMENTS.
医疗器械的消毒 产品上微生物数量的估计 第1部分:要求
1996-05-17
KS P ISO 11137-1
의료제품의 멸균 — 방사선 — 제1부: 의료기기 멸균 공정의 개발, 유효성 확인 및 일상 관리에 대한 요구사항
保健产品的灭菌 - 辐射 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制要求
2019-11-25
AS/NZS ISO 11137.1-2006
Sterilization of health care products - Radiation, Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌辐射第1部分:医疗器械灭菌过程的开发、验证和常规控制要求
2006-12-19
KS P ISO 11137-1
의료제품의 멸균 ─ 방사선 ─ 제1부: 의료기기 멸균 공정의 개발, 유효성 확인 및 일상 관리에 대한 요구사항
保健品灭菌─ 辐射─ 第1部分:医疗器械灭菌过程的开发、验证和常规控制要求
2022-12-28
GOST ISO 11137-1-2011
Стерилизация медицинской продукции. Радиационная стерилизация. Часть 1. Требования к разработке, валидации и текущему контролю процесса стерилизации медицинских изделий
保健产品的灭菌 辐射 第一部分医疗器械灭菌过程的开发 验证和常规控制要求
2011-11-29
ISO 11137-1-2025
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
保健产品的灭菌 辐射 第1部分:医疗器械灭菌过程的开发、验证和常规控制的要求
2025-04-02
UNE-EN ISO 11607-1-2009
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
最终灭菌医疗器械的包装.第1部分:材料、无菌屏障系统和包装系统的要求（ISO 11607-1-2006）
2009-10-14
UNE-EN 868-1-1997
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 1: GENERAL REQUIREMENTS AND TEST METHODS.
待灭菌医疗器械的包装材料和系统 第1部分:一般要求和试验方法
1997-11-28
AAMI/ISO 17665-1-2006/(R)2013
Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.湿热.医疗器械灭菌过程的开发、验证和常规控制的第1部分要求
2005-12-09
KS P ISO 17665-1
의료제품의 멸균 — 습열 — 제1부: 의료기기를 위한 멸균 공정 개발, 유효성 확인 및 일상관리 요구사항
保健产品灭菌 - 湿热 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制的要求
2019-11-25