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GB 19083-2023 (GB19083-2023)

Chinese standards (related to): 'GB 19083-2023'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
GB 19083-2023English369 Add to Cart 4 days Protective face mask for medical use GB 19083-2023 Valid GB 19083-2023
GB 19083-2010English70 Add to Cart 0-9 seconds. Auto delivery. Technical requirements for protective face mask for medical use GB 19083-2010 Valid GB 19083-2010
GB 19083-2003English279 Add to Cart 3 days Technical requirements for protective face mask for medical use GB 19083-2003 Obsolete GB 19083-2003


   
BASIC DATA
Standard ID GB 19083-2023 (GB19083-2023)
Description (Translated English) Protective face mask for medical use
Sector / Industry National Standard
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 18,176
Date of Issue 2023-11-27
Date of Implementation 2025-12-01
Older Standard (superseded by this standard) GB 19083-2010
Administrative Organization State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Administration for Market Regulation, National Standardization Administration


GB 19083-2023: PDF in English
GB 19083-2023: Medical protective masks
ICS 11:100
CCSC44
National Standards of People's Republic of China
Replace GB 19083-2010
medical protective mask
Published on 2023-11-27
Implemented on 2025-12-01
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Table of contents
Preface III
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 request 2
4:1 Basic requirements 2
4:2 Mask belt connection strength 2
4:3 Filtration efficiency 2
4:4 Respiratory resistance 2
4:5 Dead Space 2
4:6 Total leakage rate 3
4:7 Resistance to synthetic blood penetration 3
4:8 Microbiological indicators 3
4:9 Residual amount of ethylene oxide (if applicable) 3
4:10 Flammability (if applicable) 3
4:11 Biocompatibility 3
5 Test method 3
5:1 Test conditions 3
5:2 Basic requirements 3
5:3 Temperature and humidity pretreatment conditions 3
5:4 Mask strap connection strength 4
5:5 Filtration efficiency 4
5:6 Respiratory resistance 5
5:7 Dead Space 6
5:8 Total Leakage Rate 7
5:9 Resistance to synthetic blood penetration 8
5:10 Microbiological indicators 8
5:11 Residual amount of ethylene oxide 8
5:12 Flammability 8
5:13 Biocompatibility 8
6 Logo and instructions for use 9
6:1 Logo 9
6:2 Instructions for use 9
7 Packaging and storage 9
7:1 Packaging 9
7:2 Storage 9
Appendix A (informative) Fit testing method before mask selection10
Reference 13
Preface
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:
This document replaces GB 19083-2010 "Technical Requirements for Medical Protective Masks": Compared with GB 19083-2010, except for structural adjustment and compilation
In addition to editorial changes, the main technical changes are as follows:
a) The normative reference documents have been changed (see Chapter 2, Chapter 2 of the:2010 edition);
b) Added the terms and definitions of dead space and total leakage rate (see 3:2 and 3:3);
c) The terms and definitions of fitness factors are deleted (see 3:3 of the:2010 edition);
d) Added requirements for breathing resistance, dead space, and total leakage rate (see 4:4, 4:5, and 4:6);
e) The requirements for airflow resistance, surface moisture resistance, and adhesion are deleted (see 4:5, 4:7, and 4:12 of the:2010 edition);
f) Changed the requirements for resistance to penetration by synthetic blood (see 4:7, 4:6 of the:2010 version);
g) The requirements for microbial indicators have been changed (see 4:8, 4:8 of the:2010 edition);
h) Added requirements for biocompatibility (see 4:11):
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 and managed by the National Medical Products Administration:
The previous versions of this document and the documents it replaces are as follows:
---First published as GB 19083-2003 in:2003, first revised in:2010;
---This is the second revision:
medical protective mask
1 Scope
This document specifies the requirements, markings, instructions for use, packaging and storage of disposable medical protective masks (hereinafter referred to as "masks"):
Describes the corresponding test methods:
This document is suitable for self-priming filtration in medical working environments to filter particles in the air and block droplets, blood, body fluids, secretions, etc:
type mask (half mask):
This document does not apply to masks that protect against any chemical gases and vapors:
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 2626-2019 Respiratory protection self-priming filter-type anti-particulate respirator
GB/T 14233:1-2022 Test methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods
GB/T 16886:5 Biological evaluation of medical devices Part 5: In vitro cytotoxicity test
GB/T 16886:10 Biological evaluation of medical devices Part 10: Irritation and skin sensitization tests
GB/T 16886:12 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
GB/T 32610-2016 Technical specifications for daily protective masks
YY0469 Medical surgical mask
YY/T 0691-2008 Test method for anti-synthetic blood penetration resistance of medical masks for protective equipment against infectious pathogens (fixed volume, horizontal
injection)
YY/T 0866 Test method for total leakage rate of medical protective masks
Pharmacopoeia of the People's Republic of China (2020 Edition) Part Four
ISO 16900-5:2016/Amd:1:2018 Respiratory protective device test methods and equipment Part 5: Ventilator, metabolic simulation
Respiratory protective device headforms and phantoms, tools and verification methods/Revision 1: Respiratory protective device headform front and side views (Respiratory
sideview)
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
filteringefficiency
Under specified testing conditions, the percentage of particulate matter filtered out by the mask:
3:2
dead spacedeadspace
The volume of air that is rebreathed from the previous exhalation:
......