YY 0852-2023 Pending Industry standards-Medicine

YY 0852-2023 Sterile surgical films for single use

YY 0852-2023 Sterile surgical films for single use

Publish Date: 2023-09-05 Implement Date: 2026-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0852-2023
Standard Type: Industry standards
Standard Status: Pending
is_force_gb: no
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Medical materials
Publish Date: 2023-09-05
Implement Date: 2026-09-15
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: 16 pages

Scope

本文件规定了粘贴于手术部位、对手术切口进行无菌保护的聚氨酯手术膜和聚乙烯手术膜的性能要求,描述了相应的试验方法。本文件适用于聚氨酯手术膜和聚乙烯手术膜。

Development Information

Word Count: 23 Thousand words Pages: 16 pages

Replace the following standards

Referenced Standards

YY/T 0471.3-2004 Test methods for primary wound dressings—Part 3:Waterproofness YY/T 0471.4-2004 Test methods for primary wound dressing—Part 4:Conformability GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis 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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