The State Administration for Market Regulation and the Standardization Administration of China have jointly issued the new GB 19083-2023 "Medical Protective Masks," which will officially replace the current GB 19083-2010 version on December 1, 2025.

This is not just a routine update of the standard but also a significant improvement in technical requirements, testing items, and safety performance, affecting every company that manufactures and sells medical protective masks for compliance and market access.

01 Key changes in the new standard, fully aligned with higher requirements:

GB 19083-2023, compared to the 2010 version, includes structural adjustments and editorial changes, with the main technical changes as follows:

✅ Addition of three critical performance requirements:

The new standard adds requirements for breathing resistance, dead space, and total leakage rate, meaning that masks must ensure high filtration efficiency while also considering comfort and effective sealing during actual use.

a. Breathing resistance: Specifies the limits for inhalation and exhalation resistance (e.g., Level 1 protective masks require both inhalation/exhalation resistance ≤ 210 Pa) to ensure comfort and safety.

b. Dead space: Controls CO₂ re-inhalation to enhance respiratory safety.

c. Total leakage rate: Emphasizes the fit and protective ability in actual wearing conditions, moving beyond theoretical fit. The testing method follows YY/T0866, using the sodium flame photometry method in a pulsed sampling mode as the arbitration method.

✅ Enhanced filtration efficiency grading and requirements:

• Clearly divided into Level 1 (≥95%) and Level 2 (≥99%), with corresponding breathing resistance and leakage rate requirements, making the grading clearer and protection requirements more precise.
• The testing method has been changed from the initial filtration efficiency test of GB19083-2010 to a loaded filtration efficiency test with 50mg, and the dust concentration for filtration efficiency has been reasonably optimized, making the test closer to actual usage but also placing higher demands on the consistency of the filter material used by manufacturers.

✅ Addition of "biocompatibility" requirements:

Includes biological evaluations for skin irritation, cytotoxicity, and delayed-type hypersensitivity, ensuring more comprehensive safety of mask materials for human use.

✅ Refined microbial indicators:

• Sterilized masks must be sterile.
• Non-sterilized masks must not exceed a total microbial count of 100 CFU/g, controlling potential infection risks.

✅ Ethylene oxide residue and flammability (if applicable):

• If ethylene oxide sterilization is used, the residue must not exceed 10 μg/g.
• If the material is claimed to have flame-retardant properties, it must meet the requirement that the continued burning time does not exceed 5 seconds.

✅ Clearer labeling and instructions for use:

• The new standard requires masks to be labeled with the specified level (Level 1 or 2), closing loopholes in the previous standard regarding "filter material level or corresponding explanations" and avoiding improper associations by some manufacturers with "N95" masks.
• It also emphasizes the suitability and airtightness tests of masks, stating "due to individual facial differences, this product cannot guarantee suitability for all wearers," and requires a suitability test before use.

02 CIRS Testing provides comprehensive support:

As an authoritative third-party testing organization with CMA and CNAS qualifications, CIRS Testing always keeps up with the updates of domestic and international medical device and mask standards, offering enterprises the following services:

✅ Product compliance assessment and gap analysis

✅ Biocompatibility testing (skin irritation, cytotoxicity, delayed-type hypersensitivity)

✅ Microbial testing, ethylene oxide residue testing

✅ Standard interpretation training and technical guidance

✅ Packaging, labeling, and instruction manual compliance review

CIRS Testing will continue to monitor standard updates, helping your products achieve compliant market entry!

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.