YY/T 0720-2023 Active Industry standards-Medicine

YY/T 0720-2023 Single-use maternity kits—General requirements

YY/T 0720-2023 Single-use maternity kits—General requirements

Publish Date: 2023-01-13 Implement Date: 2024-01-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0720-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Other specialized equipment
ICS Name: Surgical instruments and materials
Publish Date: 2023-01-13
Implement Date: 2024-01-15
Publisher: 国家药品监督管理局
Technical Committee: 全国计划生育器械标准化技术委员会(SAC/TC 169)
Pages: 16 pages

Scope

本文件规定了用于产科的一次性使用产包(以下简称产包)的通用要求、产包配置及技术要求、制造商提供的信息以及包装。
本文件适用于剖腹产用手术包及自然分娩用手术包。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、上海市医疗器械检验研究院、振德医疗用品股份有限公司、河南亚都实业有限公司、江苏省医疗器械检验所、北京市医疗器械审评检查中心

Drafting Persons:

艾冲冲、姚天平、鲁建国、张正男、郑涤新、张秀丽、姚秀军、钱心依、郜艳博、段书霞、陈泱、方萍、刘雪婷、杜珩

Word Count: 24 Thousand words Pages: 16 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 0852-2011 Sterile surgical films for single use YY/T 0854.2-2011 Performance requirements for pure cotton nonwoven surgical compresses—Part 2:Finished compress YY/T 1470-2016 Disposable cut of the umbilical cord GB 7543-1996 Rubber surgical gloves GB 7543-2006 Single-use sterile rubber surgical gloves GB/T 7543-2020 Single-use sterile rubber surgical gloves 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 YY/T 0313-1998 Package,lable,transport and storage for medical polymer products YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer 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 0469-2004 Technical requirements for surgical mask YY 0469-2011 Surgical mask YY 0469-2023 Surgical mask YY/T 0506.1-2005 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 1: General requirements for manufacturers, processors and products YY/T 0506.1-2023 Surgical drapes,gowns and clean air suits for medical use—Part 1:General requirements YY 0594-2006 General requirements for surgical gauze dressings

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