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YY/T 1799-2020: Technical requirement of re-usable protective clothing for medical use
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Technical requirement of re-usable protective clothing for medical use
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YY/T 1799-2020
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Basic data | Standard ID | YY/T 1799-2020 (YY/T1799-2020) | | Description (Translated English) | Technical requirement of re-usable protective clothing for medical use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140 | | Word Count Estimation | 21,215 | | Date of Issue | 2020-12-22 | | Date of Implementation | 2021-01-01 | | Quoted Standard | GB/T 3820-1997; GB/T 3923.1-2013; GB/T 4669-2008; GB/T 4744-2013; GB/T 4745-2012; GB/T 5455-2014; GB/T 12703.3-2009; GB/T 12704.1-2009; GB 15979-2002; GB/T 16886.1; GB 19082-2009; YY/T 0506.5-2009; YY/T 0506.6-2009; YY/T 0689-2008; YY/T 0700-2008 | | Regulation (derived from) | State Drug Administration Announcement No. 140 of 2020 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance, classification and information requirements of materials and finished products of reusable medical protective clothing (hereinafter referred to as protective clothing). This standard is applicable to reusable medical protective clothing used in medical institutions to block infectious agents. This standard does not apply to surgical gowns used by medical staff to prevent cross-infection during surgical operations, does not involve disposable medical protective suits, and does not provide procedures for decontamination of protective suits. | YY/T 1799-2020: Technical requirement of re-usable protective clothing for medical use---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Technical requirement of re-usable protective clothing for medical use
ICS 11:140
C48
People's Republic of China Pharmaceutical Industry Standard
Technical requirements for reusable medical protective clothing
2020-12-22 released
2021-01-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 2
4:1 General 2
4:2 Material requirements 2
4:3 Requirements for protective clothing 4
5 sign 5
6 Information provided by the manufacturer 6
Appendix A (informative appendix) Mechanical performance classification 7
Appendix B (Normative Appendix) Test Method for Pollution Resistant Liquid Aerosol Penetration Performance 10
Appendix C (informative appendix) Design guide for protective clothing 15
Reference 17
Figure 1 Graphical symbols for biohazard protection 6
Figure B:1 Schematic diagram of test chamber 10
Figure B:2 Schematic diagram of Colison sprayer 11
Figure B:3 Sample-filter assembly with sample expanded view 11
Figure B:4 Schematic diagram of test device 13
Table 1 Penetration classification of anti-synthetic blood penetration and blood-borne pathogens 3
Table 2 Pollution prevention liquid aerosol penetration classification 3
Table 3 Microbial penetration classification in moisture barrier state 4
Table 4 Resistance to dry microbial penetration classification 4
Table 5 Microbial Index 5
Table A:1 Classification of wear resistance 7
Table A:2 Classification of flexural failure resistance 7
Table A:3 Tear strength classification 8
Table A:4 Breaking strength classification 8
Table A:5 Anti-puncture performance classification 8
Table A:6 Classification of seam strength 9
Foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is under the jurisdiction of Beijing Medical Device Inspection Institute:
Drafting organizations of this standard: Shandong Medical Device Product Quality Inspection Center, Beijing Medical Device Inspection Institute, Henan Medical Device Inspection
Laboratory, Beijing Bangwei High-tech Special Textile Co:, Ltd:, Weihai Yunlong Composite Textile Material Co:, Ltd:, Henan Yadu Industrial
Co:, Ltd:, Jiangsu New Vision Advanced Functional Fiber Innovation Center Co:, Ltd:
The main drafters of this standard: Shi Yanping, Wan Min, Zhang Qing, Wang Wenqing, Wu Ping, Xu Hui, Yao Xiujun, Huang Yongfu, Liu Keyang, Liu Xi, Xu Yuyin,
Yan Jun, Li Bo, Sun Mingzhi, Duan Shuxia, Mei Feng:
Introduction
In a medical environment where there is a risk of exposure to infectious agents, workers need to wear medical protective clothing to achieve barriers to infectious agents:
purpose:
Reusable medical protective clothing can not only save resources to a large extent, but also meet the needs of medical care in the event of a major public health event:
The demand for protective clothing has increased dramatically:
The safety and effectiveness of the decontamination process for reusable medical protective clothing is of paramount importance, and the manufacturer is responsible for providing decontamination to users:
Elimination process:
This standard classifies reusable medical protective clothing in terms of the penetration performance of infectious factors, and manufacturers are obliged to provide protective clothing
Information on the penetration performance level of the infectious factor:
The mechanical properties of protective clothing materials are related to the penetration performance, comfort, and wearing time of protective clothing:
It has guiding significance for the selection of protective clothing: Therefore, this standard refers to GB 24539-2009 and recommends in the form of an informative appendix (Appendix A)
Various mechanical properties of materials are graded, and manufacturers are encouraged to provide grade information of mechanical properties in the form of accompanying documents:
Different medical environments may require different levels of protective clothing: For clinical use, it is necessary to select the appropriate one under the guidance of clinical experts
Grade protective clothing to meet the needs of complex and changeable medical environments:
Technical requirements for reusable medical protective clothing
1 Scope
This standard specifies the performance, classification and information provision of materials and finished products of reusable medical protective clothing (hereinafter referred to as protective clothing)
Claim:
This standard applies to reusable medical protective clothing used in medical institutions to block infectious agents:
This standard does not apply to surgical gowns used by medical staff to prevent cross-infection during surgical operations, and does not involve disposable medical
Protective clothing, no decontamination procedures for protective clothing are given:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 3820-1997 Determination of the thickness of textiles and textile products
GB/T 3923:1-2013 Tensile properties of textile fabrics Part 1: Determination of breaking strength and elongation at break (strip
law)
GB/T 4669-2008 Determination of mass per unit length and mass per unit area of textile woven fabrics
GB/T 4744-2013 Textile Waterproof Performance Testing and Evaluation Hydrostatic Pressure Method
GB/T 4745-2012 Testing and Evaluation of Textile Waterproof Performance Dip Method
GB/T 5455-2014 Textile Burning Performance Determination of Damage Length in the Vertical Direction, Smoldering and Continued Burning Time
GB/T 12703:3-2009 Evaluation of electrostatic properties of textiles Part 3: Charge
GB/T 12704:1-2009 Textile fabric moisture permeability test method Part 1: Moisture absorption method
GB 15979-2002 Hygienic standard for disposable sanitary products
GB/T 16886:1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management
GB 19082-2009 Technical requirements for medical disposable protective clothing
YY/T 0506:5-2009 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments: Part 5: Prevent dry microbiology
Penetration test method
YY/T 0506:6-2009 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments: Part 6: Moisture resistance
Penetration test method
YY/T 0689-2008 Blood and body fluid protective equipment, protective clothing material anti-penetration performance test of blood-borne pathogens Phi-
X174 phage test method
YY/T 0700-2008 Blood and body fluid protective equipment protective clothing material resistance to blood and body fluid penetration performance test synthetic blood test
method
YY/T 0802-2010 Medical device sterilization manufacturer provides information on handling re-sterilizable medical devices
Pharmacopoeia of the People's Republic of China (2020 edition)
3 Terms and definitions
The following terms and definitions apply to this document:
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