YY/T 1293.2-2022 Active Industry standards-Medicine

YY/T 1293.2-2022 Contacting wound dressing—Part 2:Polyurethane foam dressing

YY/T 1293.2-2022 Contacting wound dressing—Part 2:Polyurethane foam dressing

Publish Date: 2022-10-17 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1293.2-2022
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical hygiene products
ICS Name: Medical materials
Publish Date: 2022-10-17
Implement Date: 2023-10-01
Publisher: 国家药品监督管理局
Technical Committee: 山东省医疗器械和药品包装检验研究院
Pages: 12 pages

Scope

本文件规定了聚氨酯泡沫敷料的要求和试验方法。
本文件适用于无菌供应的液体吸收层为聚氨酯泡沫的敷料。
本文件不适用于含银等抑菌剂、含有活性成分或能释放活性物质/能量的物质、人/动物源性材料、组织工程材料、可降解材料等的聚氨酯泡沫敷料和负压引流用聚氨酯泡沫敷料(海绵)。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、山东新华安得医疗用品有限公司、施乐辉医用产品国际贸易(上海)有限公司、浙江隆泰医疗科技股份有限公司、振德医疗用品股份有限公司、明尼苏达矿业制造(上海)国际贸易有限公司

Drafting Persons:

林则晨、师广波、张军、肖友松、陈甜、陈巧芳、亓晓庆、冯幼强、聂君、褚祥宇

Word Count: 20 Thousand words Pages: 12 pages

Replace the following standards

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods YY/T 0471.1-2004 Test methods for primary wound dressing—Part 1:Aspects of absorbency YY/T 0471.2-2004 Test methods for primary wound dressings—Part 2:Moisture vapour transmission rate of permeable film dressings YY/T 0471.3-2004 Test methods for primary wound dressings—Part 3:Waterproofness YY/T 0471.5-2017 Test methods for primary wound dressings—Part 5:Bacterial barrier properties 中华人民共和国药典(2020年版 四部) GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process 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 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices

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