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

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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

Pages: 20 pages

Scope

This document specifies the general requirements for medical surgical drapes, surgical gowns, and cleanroom garments. It includes performance requirements, manufacturing requirements, post-use treatment requirements for reusable products, and information requirements provided by manufacturers. It does not include anti-laser penetration performance or antibacterial treatment requirements for surgical gowns or surgical drapes.
This document applies to medical surgical drapes, surgical gowns, and cleanroom garments.
This document does not apply to surgical membranes.
Note 1: The special requirements for surgical drapes, surgical gowns, and cleanroom garments are specified in YY/T 0506.8.
Note 2: The test methods and classification for anti-laser penetration performance are specified in YY/T 0855.

Development Information

Word Count: 42 Thousand words Pages: 20 pages

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

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GB/T 17257.1-1998 Replaced

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GB/T 17257.2-1998 Replaced

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GB/T 17257.3-1998 Replaced

GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume

Publish Date: 1998-03-18

GB/T 17257.4-1998 Replaced

GB/T 17257.4-1998 Urine collection bags—Part 4:Determination of freedom form leakage

Publish Date: 1998-03-18