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
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
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
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 868-2-2009
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
最终灭菌医疗器械的包装第2部分:灭菌包装要求和试验方法
2009-12-02
YY/T 0698.2-2022
最终灭菌医疗器械包装材料 第2部分：灭菌包裹材料 要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
2022-10-17
AAMI/ISO 11607-2-2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
最终灭菌医疗器械的包装.第2部分:成型、密封和组装工艺的验证要求
KS P ISO 11607-2
최종 멸균 처리한 의료기기의 포장 — 제2부: 성형, 봉함 및 조립 공정에 대한 유효성 확인 요구사항
终端灭菌医疗器械的包装 - 第2部分:成型 密封和装配过程的验证要求
2018-11-05
KS P ISO 11607-2
최종 멸균 처리한 의료기기의 포장 —제2부: 성형, 봉함 및 조립 공정에 대한 유효성 확인 요구사항
最终灭菌医疗器械的包装.第2部分:成型、密封和装配工艺的验证要求
2021-06-28
GB/T 19633.2-2015
最终灭菌医疗器械包装 第2部分：成形、密封和装配过程的确认的要求
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
2015-12-10
ISO 11607-2-2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
最终灭菌医疗器械包装第2部分:成形 密封和装配过程的验证要求
2019-01-31
SN/T 3062.2-2011
进口医疗器械灭菌包装 第2部分：纸袋-要求和试验方法
Pachaking materials for terminally sterilized medical devices for import--Part 2:Paper bags--Requirements and test methods
2011-09-09
UNE-EN ISO 11607-2-2007
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
最终灭菌医疗器械的包装第2部分:成型、密封和组装工艺的验证要求
2007-03-28
ISO 11607-2-2019/Amd 1-2023
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
最终灭菌医疗器械包装第2部分:成型、密封和组装过程的验证要求修改件1:风险管理的应用
2023-09-13