GB 9706.8-1995
Replaced
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
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
Replace the following standards
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 0506.2-2016 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 2:Performance requirements and test methods
YY/T 0506.7-2014 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 7:Test methods for determination of cleanliness-microbial
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
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced