SG 45/24
China issued an updated version of its national product standard GB 19083-2023 ‘Protective face mask for medical use’ on November 27, 2023. It will become effective on December 1, 2025.
The Standardization Administration of China issued its national product standard GB 19083-2023 ‘Protective face mask for medical use’ as part of China’s No. 12 announcement on the approved national standards in 2023. It will replace the previous version, GB 19083-2010, and will become effective on December 1, 2025.
Scope
This standard applies to non-powered filter masks (half masks) that filter particulate matter in the air and block droplets, blood, body fluids, secretions, etc. in medical work environments.
Main technical contents
- Face masks should meet general requirements, including material and design construction
- Materials should meet applicable performance requirements, including mask band joint strength, filtration efficiency, inhalation and exhalation resistance, dead space, total leakage, resistance to penetration by synthetic blood, microorganism test, ethylene oxide residue, flammability test and biocompatibility
- Marking, user instructions
- Packaging and storage
Main technical changes
Compared with GB 19083-2010, GB 19083-2023 contains many updates, including:
Revisions include:
- Normative reference documents
- Resistance to penetration by synthetic blood requirement
- Microorganism test requirement
Additions include:
- Terms and definitions of dead space, total leakage
- Requirement of inhalation and exhalation resistance, dead space, total leakage
- Biocompatibility requirement
Deletions include:
- Terms and definitions of fit factors
- Requirement of airflow resistance, water resistance (spray test), air tightness
Details of the Technical Content
For more information, please refer to the China National Standard GB 19082-2023 ‘Disposable protective clothing for medical use’ or contact SGS directly.
As the world’s leading testing, inspection, verification and certification service provider, we operate a global network of state-of-the-art laboratories to help manufacturers produce high-quality, compliant PPE products. Contact us for more information or visit our website. In the end, it’s only trusted because it’s tested.
© SGS Société Générale de Surveillance SA. This publication or website is a property of SGS Société Générale de Surveillance SA. All contents including website designs, text, and graphics contained herein are owned by or licensed to SGS Société Générale de Surveillance SA. The information provided is for technical and general information purposes only and offers no legal advice. The information is no substitute for professional legal advice to ensure compliance with the applicable laws and regulations. All information is provided in good faith “as is”, and SGS Société Générale de Surveillance SA makes no representation or warranty of any kind, express or implied, and does not warrant that the information will be error-free or meet any particular criteria of performance or quality.
