YY 1885-2023 English PDF

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YY 1885-2023: Negative pressure isolators for transport of infectious patients
Status: Valid

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YY 1885-2023	299	Add to Cart	3 days	Negative pressure isolators for transport of infectious patients	Valid

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Basic data

Standard ID: YY 1885-2023 (YY1885-2023)
Description (Translated English): Negative pressure isolators for transport of infectious patients
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C47
Classification of International Standard: 11.140
Word Count Estimation: 14,166
Date of Issue: 2023-06-20
Date of Implementation: 2025-07-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements, test methods, labels and instructions for transporting infectious disease patients to negative pressure isolation cabins. This standard applies to the negative pressure isolation cabins used to isolate and transport patients with infectious diseases to prevent the spread of pathogens to the external environment. This standard does not apply to isolation compartments used for transfer of the wounded in safety accidents such as fire, nuclear accidents, and chemical substance leakage.

YY 1885-2023: Negative pressure isolators for transport of infectious patients

---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 Transporting infectious disease patients to negative pressure isolation cabins Published on 2023-06-20 2025-07-01 Implementation Released by the State Drug Administration

Table of contents

Preface III 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Requirements 2 4.1 Basic requirements 2 4.2 Dimensional tolerance 2 4.3 Load bearing (if applicable) 2 4.4 Filter element 2 4.5 Glove mouth wind speed 2 4.6 Window transmittance 2 4.7 Negative pressure 2 4.8 Number of air exchanges 3 4.9 Filter element integrity3 4.10 Shell protection 3 4.11 Noise 3 4.12 Disinfection resistance3 4.13 Power requirements 3 4.14 Alarm 3 4.15 Electrical safety 3 4.16 Electromagnetic compatibility 4 4.17 Environmental test 4 5 Test method 4 5.1 Test and pretreatment conditions 4 5.2 Basic requirements 4 5.3 Size 4 5.4 Load bearing 4 5.5 Filter element 4 5.6 Glove mouth wind speed 4 5.7 Window transmittance 5 5.8 negative pressure 5 5.9 Air exchange rate 5 5.10 Filter element integrity5 5.11 Housing protection 6 5.12 Noise 6 5.13 Disinfection resistance 6 5.14 Power requirements 6 5.15 Alarm 6 5.16 Electrical safety 7 5.17 Electromagnetic compatibility7 5.18 Environmental test 7 6 Logo and instructions for use 8 6.1 Identification 8 6.2 User Manual 8 Reference 9

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. Transporting infectious disease patients to negative pressure isolation cabins

1 Scope

This document specifies the requirements, test methods, labels and instructions for use in negative pressure isolation chambers for transporting patients with infectious diseases. This document applies to negative pressure isolation cabins used to isolate and transport patients with infectious diseases to prevent the spread of pathogens to the external environment. This document does not apply to isolation compartments used for the transfer of injured persons in safety accidents such as fires, nuclear accidents, chemical leaks, etc.

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 4208-2017 Shell protection level (IP code) GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances GB 30864-2014 Respiratory protection powered air purifying respirator GB 50346-2011 Technical specifications for biosafety laboratory construction 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 YY 9706.108 Medical electrical equipment Part 1-8.General requirements for basic safety and basic performance Parallel standards. General requirements Looking for testing and guidance on alarm systems in medical electrical equipment and medical electrical systems

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 A mobile device used for the isolation and transportation of infectious disease patients, consisting of a cabin, a ventilation system, an air filter element and a pressure monitoring device By adjusting the ventilation system, a negative pressure environment is formed in the cabin to ensure that the air in the cabin is only filtered by high-efficiency air filter elements before being discharged. Go outside the cabin. Note. Referred to as "negative pressure isolation cabin". 3.2 The air filter element used at the air inlet and exhaust port of the negative pressure isolation cabin generally consists of a filter element and a housing. 3.3 Air exchange rateairexchangerate The ventilation value per unit time is calculated by dividing the volume of air entering per unit time by the volume of the space. [Source. GB/T 25915.3-2010,3.4.1] ......

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