YY/T 0567.1-2013
医疗保健产品的无菌加工 第1部分:通用要求
Aseptic processing of health care products-Part 1:General requirements
2013-10-21
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
KS P ISO 13408-1
헬스케어 제품의 무균 공정 ─ 제1부: 일반 요구사항
保健产品的无菌加工 - 第1部分:总则
要求
2017-09-29
YY/T 0567.5-2011
医疗保健产品的无菌加工 第5部分：在线灭菌
Aseptic processing of health care products—Part 5:Sterilization in place
2011-12-31
YY/T 0567.3-2011
医疗保健产品的无菌加工 第3部分：冻干法
Aseptic processing of health care products—Part 3:Lyophilization
2011-12-31
YY/T 0567.7-2016
医疗保健产品的无菌加工 第7部分：医疗器械及组合型产品的替代加工
Aseptic processing of health care products—Part 7:Alternative processes for medical devices and combination products
2016-07-29
YY/T 0567.4-2011
医疗保健产品的无菌加工 第4部分:在线清洗技术
Aseptic processing of health care products-Part 4:Clean-in-place technologies
2011-12-31
YY/T 0567.2-2021
医疗保健产品的无菌加工 第2部分：除菌过滤
Aseptic processing of health care products—Part 2:Sterilizing filtration
2021-03-09
YY/T 0567.6-2022
医疗保健产品的无菌加工 第6部分：隔离器系统
Aseptic processing of health care products—Part 6:Isolator systems
2022-08-17
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
AAMI/ISO 13408-1-2008/(R)2017 & A1-2013/(R)2017
Aseptic processing of health care products--Part 1: General requirements
保健品的无菌加工第1部分:一般要求
2008-09-23
KS P ISO 13408-1
의료 제품의 무균 공정 제 제1부부: 일반 요구사항
保健品的无菌加工.第1部分:一般要求
2022-12-28
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
EN ISO 13408-7-2015
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
保健产品的无菌加工 - 第7部分:医疗器械和组合产品的替代工艺（ISO 13408-7:2012）
2015-08-05
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
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
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 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
EN ISO 11607-1-2020/A1-2023
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
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修改1
2023-10-25
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