GB19083-2023
Protective face mask for medical use
医用防护口罩
GB 19083-2023 is a current mandatory Chinese national standard for Protective face mask for medical use. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Dec 1, 2025.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard applies to disposable protective face masks for medical use (self-priming filter type half-masks) designed for medical environments. It covers masks intended to filter particulates and block droplets, blood, and body fluids. It is not applicable to masks designed for protection against chemical gases and vapors. Manufacturers of medical PPE must ensure their products align with these mandatory requirements.
Technical requirements
The standard outlines comprehensive physical, chemical, and biological requirements. Masks must not have an exhalation valve and must securely cover the mouth and nose. Manufacturers must ensure strict adherence to the structural and material guidelines to pass compliance evaluations. Key parameters include mask strap connection strength, which dictates the breaking force of the straps and their attachment points. Performance is categorized into Tier 1 and Tier 2 levels based on filtration efficiency against non-oily particles. The standard sets specific limits for breathing resistance (inhalation and exhalation) and total inward leakage (TIL). Additionally, it introduces new requirements for dead space, limiting the re-inhaled carbon dioxide volume to ensure user safety. Biological and safety criteria are also heavily featured. Masks must demonstrate resistance to synthetic blood penetration under specified pressure. Microbial limits are defined for both sterile and non-sterile states, and strict limits are placed on ethylene oxide residue if applicable. Compliance with biocompatibility standards for skin irritation, cytotoxicity, and delayed-type hypersensitivity is now a mandatory addition.
Testing methods
Testing procedures require rigorous temperature and humidity pre-treatment to simulate real-world conditions. Filtration efficiency is evaluated using a sodium chloride aerosol loading test. Breathing resistance is measured on a standardized headform at a specified flow rate. Testing for total inward leakage involves human subjects performing a series of standardized movements. Other key tests include synthetic blood penetration resistance, microbial limit testing per the Chinese Pharmacopoeia, and flammability assessments using a specific flame contact method.
FAQs
What products are regulated under GB 19083-2023?
GB 19083-2023 applies to disposable protective face masks for medical use designed for medical environments. It does not cover masks intended for protection against chemical gases and vapors.
Are there any significant updates from the previous GB 19083-2010 version?
The 2023 version introduces new requirements for dead space, total inward leakage (TIL), and biocompatibility. It also removes previous requirements for surface moisture resistance and airflow resistance, replacing the latter with specific breathing resistance metrics.
How does GB 19083-2023 differ from international respirator standards?
While it shares similarities with international standards like ISO 16900-5 and EN 149, GB 19083-2023 is specifically tailored for medical environments. It places a strong emphasis on synthetic blood penetration resistance and includes a mandatory fit-testing procedure detailed in its appendix.
The summary above provides a high-level overview of GB 19083-2023. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 19083-2023 today to access all detailed parameters, tables, and testing procedures.
Applicability hints
- Type
- Product
- CCS
- C44
- ICS
- 11.100
- Competent department
- National Medical Products Administration
- Technical committee
- National Standardization Working Group on Medical Protective Devices
Relationships
Replaces:GB 19083-2010