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

Publish Date: 2023-09-05 Implement Date: 2024-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 33 Thousand words Pages: 16 pages

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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