GB 18278-2000
Replaced
GB/T 19633.1-2024
Active
National standards
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
Basic Information
Standard Code:
GB/T 19633.1-2024
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2024-05-28
Implement Date:
2025-12-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
Pages:
63 pages
Scope
本文件规定了预期在使用前保持最终灭菌医疗器械无菌的材料、预成型无菌屏障系统、无菌屏障系统和包装系统的要求和试验方法。
本文件未包括无菌制造医疗器械的无菌屏障系统和包装系统的全部要求。对药物与器械组合的情况，还可能需要有其他要求。
本文件未描述所有制造阶段控制的质量保证体系。
本文件不适用于运送受污染医疗器械至再加工或处置地期间的包装材料和/或包装系统。
Development Information
Drafting Units:
广东省医疗器械质量监督检验所、上海微创医疗器械(集团)有限公司、杜邦(中国)研发管理有限公司、南微医学科技股份有限公司、上海建中医疗器械包装股份有限公司、安姆科集团毕玛时软包装(苏州)有限公司
Drafting Persons:
万易易、李然、秦蕾、丁艳琴、汪友琼、钱军、王芳颖、袁碧钰、李勇、李宁、宋翌勤、王清
Same series standard
Replace the following standards
Referenced Standards
ISO 5636-5
ISO 11607-2
Adopt standards
ISO 11607-1:2019
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced