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YY 1887-2023 English PDF

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YY 1887-2023: Positive pressure protective clothing(PPPC) for medical use
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YY 1887-2023English919 Add to Cart 6 days [Need to translate] Positive pressure protective clothing(PPPC) for medical use Valid YY 1887-2023

PDF similar to YY 1887-2023


Standard similar to YY 1887-2023

YY 1881   YY/T 1737   YY/T 1623   YY 1885   

Basic data

Standard ID YY 1887-2023 (YY1887-2023)
Description (Translated English) Positive pressure protective clothing(PPPC) for medical use
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C47
Classification of International Standard 11.140
Word Count Estimation 45,484
Date of Issue 2023-06-20
Date of Implementation 2025-07-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the structural composition, requirements, testing methods, marking and instructions for use, packaging and storage of medical positive pressure protective clothing. This standard applies to medical positive pressure protective clothing used to filter microbial particles in the air and block pollutants such as droplets and blood in scenarios such as medical work environments where the risk of exposure to pathogenic microbial aerosols has been assessed. This standard does not apply to medical positive pressure protective clothing whose clothing part is reusable. This standard does not apply to personal protective equipment in biosafety level 4 laboratories or similar risky operating environments. This standard does not apply to personal protective equipment in dust, chemical gas, combustion, explosion, hypoxia and other environments.

YY 1887-2023: Positive pressure protective clothing(PPPC) 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.
ICS 11.140 CCSC47 Pharmaceutical Industry Standards of the People's Republic of China Medical positive pressure protective clothing Published on 2023-06-20 2025-07-01 Implementation Released by the State Drug Administration

Table of contents

Preface V 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 2 4 Structural composition 3 5 Requirements 3 5.1 Basic requirements 3 5.2 Primary skin irritation3 5.3 Physical properties of protective clothing materials3 5.3.1 Tear strength 3 5.3.2 Breaking strength 4 5.3.3 Puncture resistance 4 5.3.4 Seam strength 4 5.4 Liquid barrier properties of protective clothing materials 4 5.4.1 Water resistance 4 5.4.2 Surface moisture resistance4 5.4.3 Resistance to synthetic blood penetration 4 5.4.4 Resistance to phage penetration 4 5.5 Connection Strength5 5.6 Windows 5 5.6.1 Light transmittance and haze5 5.6.2 Visual distortion 5 5.6.3 Window mechanical strength 5 5.7 Filter element 5 5.7.1 Basic requirements 5 5.7.2 Mechanical strength 5 5.7.3 Filtration efficiency 5 5.8 Minimum air supply volume 5 5.9 Continuous use time5 5.10 Air supply tube crush resistance5 5.11 Internal pressure of protective clothing5 5.11.1 Static pressure 5 5.11.2 Dynamic pressure 6 5.12 Exhaust valve (if applicable) 6 5.12.1 Exhaust valve sealing 6 5.12.2 Exhaust valve connection strength 6 5.13 Total leak rate 6 5.14 Tip 6 5.14.1 Low air supply volume prompt 6 5.14.2 Low battery prompt 6 5.15 Dead space 7 5.16 Noise 7 5.17 Call performance7 5.18 Microbiological indicators 7 5.19 Residual amount of ethylene oxide (if applicable) 7 5.20 Environmental test 7 5.21 Electrical safety and electromagnetic compatibility7 6 Detection method 7 6.1 Test conditions 7 6.2 Primary skin irritation7 6.3 Environmental test 7 6.4 Preprocessing conditions 8 6.5 Basic requirements 8 6.6 Physical properties of protective clothing materials8 6.6.1 Tear strength 8 6.6.2 Breaking strength 9 6.6.3 Puncture resistance9 6.6.4 Seam strength 9 6.7 Liquid barrier properties of protective clothing materials9 6.7.1 Water resistance 9 6.7.2 Surface moisture resistance9 6.7.3 Resistance to synthetic blood penetration 9 6.7.4 Resistance to phage penetration 9 6.8 Connection Strength9 6.9 Windows 9 6.9.1 Light transmittance and haze9 6.9.2 Visual distortion 9 6.9.3 Window mechanical strength10 6.10 Filter elements 10 6.10.1 Basic requirements 10 6.10.2 Mechanical strength10 6.10.3 Filtration efficiency10 6.11 Minimum air supply volume 11 6.11.1 Sample quantity and requirements11 6.11.2 Device 11 6.11.3 Test method 12 6.12 Continuous use time12 6.13 Air supply tube crush resistance12 6.14 Internal pressure of protective clothing12 6.14.1 Static pressure12 6.14.2 Dynamic pressure 13 6.15 Exhaust valve 13 6.15.1 Sample quantity and requirements13 6.15.2 Exhaust valve sealing13 6.15.3 Exhaust valve connection strength 13 6.16 Total leak rate 13 6.17 Tip 14 6.17.1 Low air supply volume prompt 14 6.17.2 Low battery prompt 14 6.18 Dead space 14 6.18.1 Sample quantity and requirements 14 6.18.2 Testing equipment 14 6.18.3 Detection method 15 6.19 Noise 15 6.20 Call performance16 6.21 Microbiological indicators 16 6.21.1 Sterility test 16 6.21.2 Microbiological limits 16 6.22 Residual amount of ethylene oxide16 6.23 Electrical safety and electromagnetic compatibility16 7 Markings and instructions for use16 7.1 Flag 16 7.1.1 Protective clothing16 7.1.2 Electric air supply system 16 7.1.3 Filter elements 17 7.2 Instructions for use17 8 Packaging and storage17 Appendix A (Normative) Practical Performance Evaluation 18 A.1 Sample and tester requirements 18 A.2 Assessment methods18 A.3 Assessment Report 20 Appendix B (Normative) Visual Distortion Test Method 21 B.1 Principle 21 B.2 Eye chart 21 B.3 Sample and tester requirements 21 B.4 Test method 21 B.5 Result Judgment 21 Appendix C (Normative) Total Leakage Rate Test Method 22 C.1 Principle 22 C.2 Sample and subject requirements22 C.3 Test method 22 C.4 Results Report 26 Appendix D (normative) Noise and prompt volume test methods 27 D.1 Equipment 27 D.2 Ear structure and test equipment installation 27 D.3 Sample requirements 28 D.4 Noise test method 28 D.5 Prompt volume test method 28 Appendix E (normative) Call performance test method 29 E.1 Equipment 29 E.2 Test materials 29 E.3 Tester 29 E.4 Sample requirements 29 E.5 Pre-test training 29 E.6 Test 31 E.7 Rating 31 Appendix F (informative) Summary of testing requirements 35 Reference 37

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the technical unit responsible for standardization of medical biological protection products. Medical positive pressure protective clothing

1 Scope

This document specifies the structural composition, requirements, testing methods, markings, instructions for use, packaging and storage of medical positive pressure protective clothing. This document is applicable to scenarios such as medical work environments where the risk of exposure to pathogenic microorganism aerosols has been assessed, and is used to filter airborne Medical positive pressure protective clothing that contains microbial particles and blocks droplets, blood and other pollutants. This document does not apply to medical positive pressure protective clothing whose clothing part is reusable. This document does not apply to personal protective equipment in biosafety level 4 laboratories or equivalent risk operating environments. This document does not apply to personal protective equipment in environments such as dust, chemical gases, combustion, explosion, and lack of oxygen.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 2410-2008 Determination of transmittance and haze of transparent plastics GB 2626-2019 Respiratory protection self-priming filter-type anti-particulate respirator GB/T 3785.1-2010 Electroacoustic sound level meter Part 1.Specifications GB/T 3917.3 Tear properties of textile fabrics Part 3.Determination of tearing strength of trapezoidal specimens GB/T 4744-2013 Hydrostatic pressure method for testing and evaluation of waterproof properties of textiles GB/T 4745-2012 Testing and evaluation of waterproof properties of textiles by water exposure method GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance GB/T 11533-2011 Standard logarithmic eye chart GB/T 12903-2008 Personal protective equipment terminology GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances GB/T 15508-1995 Acoustic speech intelligibility test method GB/T 16886.10 Biological evaluation of medical devices Part 10.Irritation and skin sensitization tests GB/T 20655 Determination of mechanical properties of protective clothing and puncture resistance GB/T 21294-2014 Testing methods for physical and chemical properties of clothing GB/T 24218.3 Test methods for textile nonwovens Part 3.Determination of breaking strength and elongation at break (strip method) GB 30864-2014 Respiratory protection powered air purifying respirator YY/T 0689-2008 Blood and body fluid protective equipment protective clothing materials anti-penetration performance test of blood-borne pathogens Phi- X174 bacteriophage test method YY/T 0700-2008 Blood and body fluid protection equipment and protective clothing materials anti-blood and body fluid penetration performance test synthetic blood test method YY/T 0866 Test method for total leakage rate of medical protective masks YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance Parallel standards. Electromagnetic and Capacity requirements and testing

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