DZ/T 0101.12-1994
Active
YY/T 0698.5-2023
Active
Industry standards-Medicine
YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods
YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods
Basic Information
Standard Code:
YY/T 0698.5-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
-
Publish Date:
2023-09-05
Implement Date:
2024-09-15
Publisher:
国家药品监督管理局
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
16 pages
Scope
本文件规定了符合YY/T 0698.2、0698.3、0698.6、0698.7、0698.9或0698.10透气材料和符合本文件第4章规定的塑料膜组成的可密封组合袋和卷材的要求和试验方法。这些可密封组合袋和卷材可用作无菌屏障系统和/或包装系统,以保证最终灭菌医疗器械到使用时的无菌性。除GB/T 19633.1和GB/T 19633.2规定的通用要求外,本文件规定了本部分涵盖的材料的专用要求和试验方法。本文件仅适用于一次性使用的最终灭菌医疗器械包装材料。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、杜邦(中国)研发管理有限公司、上海建中医疗器械包装股份有限公司、山东新华医疗器械股份有限公司、浙江康德莱医疗器械股份有限公司
Drafting Persons:
王冬伟、钱军、汪友琼、韩兴伟、张博、陈方、张谦
Replace the following standards
Referenced Standards
GB/T 7408-1994 Data elements and interchange formats—Information interchange—Representation of dates and times
GB/T 7408-2005 Data elements and interchange formats—Information interchange—Representation of dates and times
GB/T 7408.1-2023 Date and time—Representations for information interchange—Part 1:Basic rules
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
GB 18282.1-2015 Sterilization of health care products—Chemical indicator—Part 1:General requirements
GB/T 19633.1-2015 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
YY/T 0681.2-2010 Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
YY/T 0698.2-2022 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
YY/T 0698.3-2009 Packaging materials for terminal sterilized medical devices—Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5)—Requirements and test methods
YY/T 0698.6-2009 Packaging materials for terminal sterilized medical devices—Part 6:Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods
YY/T 0698.7-2009 Packaging materials for terminal sterilized medical devices—Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods
YY/T 0698.9-2009 Packaging materials for terminally sterilized medical devices—Part 9:Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods
YY/T 0698.10-2009 Packaging materials for terminally sterilized medical devices—Part 10:Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods
GB/T 18282.1-2025 Sterilization of health care products—Chemical indicators—Part 1:General requirements
GB/T 7408.2-2025 Date and time—Representation for information interchange—Part 2:Extensions
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