YY/T 1799-2020 English PDF

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YY/T 1799-2020: Technical requirement of re-usable protective clothing for medical use
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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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