YY/T 0506.1-2023 Active Industry standards-Medicine

YY/T 0506.1-2023 Surgical drapes,gowns and clean air suits for medical use—Part 1:General requirements

YY/T 0506.1-2023 Surgical drapes,gowns and clean air suits for medical use—Part 1: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 0506.1-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Surgical room equipment
ICS Name: Medical equipment
Publish Date: 2023-01-13
Implement Date: 2024-01-15
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: 20 pages

Scope

本文件规定了医用手术单、手术衣和洁净服的通用要求。包括性能要求、制造要求、可重复使用产品使用后处理要求以及制造商提供的信息要求。不包括抗激光穿透性能、手术衣或手术单的抗菌处理要求。
本文件适用于医用手术单、手术衣和洁净服。
本文件不适用于手术膜。
注1:  手术单、手术衣和洁净服的专用要求见YY/T 0506.8。
注2:  抗激光穿透性能试验方法和分类见YY/T 0855。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、振德医疗用品股份有限公司、威海威高医用材料有限公司、北京鹊翔腾飞医疗科技有限公司、河南亚都实业有限公司、江苏卫护医疗科技有限公司、合肥高贝斯医疗卫生用品有限公司、普杰无纺布(中国)有限公司

Drafting Persons:

张庆、王文庆、常改玲、于许杰、蒋礼恒、刘斌、段书霞、寇伟、聂佳祺、高明、金永吉、李翠、李秀婷、朱艺馨

Word Count: 42 Thousand words Pages: 20 pages

Replace the following standards

Referenced Standards

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 6529-1986 Standard atmospheres for textiles conditioning and testing GB/T 6529-2008 Textiles—Standard atmospheres for conditioning and testing GB/T 7742.1-2005 Textiles—Bursting properties of fabrics—Part 1:Hydraulic method for determination of bursting strength and bursting distension 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 24218.3-2010 Textiles—Test methods for nonwovens—Part 3:Determination of tensile strength and elongation(strip method) YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0506.4-2005 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 4: Test method for linting in the dry state YY/T 0506.4-2016 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 4:Test method for linting in the dry state YY/T 0506.5-2009 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 5:Test method for resistance to dry microbial penetration YY/T 0506.6-2009 Surgical drapes,gowns and clean air suits,used as medical devices,for patients,clinical staff and equipment—Part 6:Test method to determine the resistance to wet bacterial penetration

Related Standards

Contact Us