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
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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
Pages: 16 pages

Scope

This document specifies the requirements and test methods for sealable composite bags and rolls made of breathable materials that comply with YY/T 0698.2, 0698.3, 0698.6, 0698.7, or 0698.9, or plastic films that comply with the provisions of Chapter 4 of this document. These sealable composite bags and rolls can be used as sterile barrier systems and/or packaging systems to ensure the sterility of the final sterilized medical devices until they are used. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this document specifies the special requirements and test methods for the materials covered in this section. This document is only applicable to packaging materials for single-use, final sterilized medical devices.

Development Information

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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