DZ/T 0101.12-1994
Active
YY/T 0698.2-2022
Active
Industry standards-Medicine
YY/T 0698.2-2022 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
Basic Information
Standard Code:
YY/T 0698.2-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
-
Publish Date:
2022-10-17
Implement Date:
2023-10-01
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:
14 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预成形屏障系统和包装系统的材料的要求和试验方法。
本文件适用于预期为一次性使用的平纸包裹材料、皱纹纸包裹材料、非织造布包裹材料和预期为重复性使用的纺织包裹材料的性能测定。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、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、杜邦(中国)研发管理有限公司、浙江康德莱医疗器械股份有限公司
Drafting Persons:
张鹏、高冉冉、宋翌勤、韩兴伟、钱军、张谦、彭建、于晓慧、汪友琼
Replace the following standards
Referenced Standards
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
中华人民共和国药典2020年版 四部
ISO 9197
ISO 9198
GB/T 451.2-2002 Paper and board—Determination of grammage
GB/T 451.2-2023 Paper and board—Part 2:Determination of grammage
GB/T 454-2002 Paper—Determination of bursting strength
GB/T 454-2020 Paper—Determination of bursting strength
GB/T 455-2002 Paper and board determination of tearing resistance
GB/T 458-2002 Paper and board—Determination of air permeance (Schopper method)
GB/T 458-2008 Paper and board—Determination of air permeance
GB/T 465.1-2008 Paper and board—Determination of bursting strength after immersion in water
GB/T 465.2-2008 Paper and board—Determination of tensile strength after immersion in water
GB/T 1540-2002 Paper and board-Determination of water absorption-Cobb method
GB/T 1545-2008 Paper,board and pulp—Determination of acidity or alkalinity
GB/T 1545.1-2003 Paper, board and pulp-Determination of acidity or alkalinity
GB/T 1545.2-2003 Paper, board and pulp-Determination of pH of aqueous extracts
GB/T 3917.1-1997 Textiles—Tear properties of fabrics—Part 1:Determination of tear force—Ballistic pendulum method (Elmendorf)
GB/T 3917.1-2009 Textiles—Tear properties of fabrics—Part 1:Determination of tear force using ballistic pendulum method (Elmendorf)
GB/T 4744-1997 Textile fabrics—Determination of resistance to water penetration—Hydrostatic pressure test
GB/T 4744-2013 Textiles—Testing and evaluation for water resistance—Hydrostatic pressure method
GB/T 5453-1997 Textiles—Determination of the permeability of fabrics to air
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/T 7742.1-2005 Textiles—Bursting properties of fabrics—Part 1:Hydraulic method for determination of bursting strength and bursting distension
GB/T 7974-2002 Paper, board and pulp-Measurement of brightness—Diff/Geometry
GB/T 7974-2013 Paper,board and pulps—Measurement of diffuse blue reflectance factor—D65 brightness(Diff/ Geometry,Outdoor daylight conditions)
GB/T 10739-2002 Paper, board and pulps—Standard atmosphere for conditioning and testing
GB/T 10739-2023 Paper,board and pulps—Standard atmosphere for conditioning and testing
GB/T 12914-1991 Paper and board—Determination of tensile properties—Constant rate of elongation method
GB/T 12914-2008 Paper and board—Determination of tensile properties
GB/T 12914-2018 Paper and board—Determination of tensile properties—Constant rate of elongation method(20 mm/min)
GB/T 24218.3-2010 Textiles—Test methods for nonwovens—Part 3:Determination of tensile strength and elongation(strip method)
GB/T 5453-2025 Textiles—Determination of the permeability of fabrics to air
GB/T 7408.2-2025 Date and time—Representation for information interchange—Part 2:Extensions
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