The new national standard GB 41918-2022 “Biosafety Cabinets” replaces YY 0569-2011 “Class II Biosafety Cabinets” and regulates biosafety cabinets as “medical-related equipment”. The standard was published on 12 October 2022 and took effect on 1 November 2025.
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GB 41918-2022 is a national standard jointly issued by the State Administration for Market Regulation (SAMR) and the Standardization Administration of China (SAC), specifically governing the manufacture, testing and use of biosafety cabinets.
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According to the Guidelines for Registration Review of Biosafety Cabinets, Class II biosafety cabinets as defined in YY 0569 are classified under code 22-16-01 in the Medical Device Classification Catalogue (CFDA Announcement No. 104 of 2017) and are regulated as Class III medical devices.
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Class II biosafety cabinets as defined in YY 0569 are medical devices exempt from clinical evaluation. Applicants should submit the relevant documents in accordance with the Technical Guidelines for Comparison of Products Listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation
Link to the Guidelines for Registration Review of Biosafety Cabinets: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.nmpa.gov.cn%2Fdirectory%2Fweb%2Fnmpa%2Fimages%2F1642559383069031523.docx&wdOrigin=BROWSELINK
Looking at the “Requirements” chapter of the standard, the changes focus mainly on materials, structure, the testing process and safety functions.
1. Material requirements
2. Testing process
The standard divides testing into four types – “factory testing, type testing, installation testing and maintenance testing” – each with clear non-conformity rules: if any single item fails, that test is judged non-conforming.
The “Test methods” chapter of the standard is extensive; we have condensed it into the following 10 key points.
1. Appearance and material inspection
2. Cabinet leak-tightness test
3. HEPA filter integrity test
4. Noise test
5. Illuminance test
6. Vibration test
7. Personnel / product / cross-contamination protection test
8. Airflow velocity test
9. Electrical safety test
10. Environmental and electromagnetic compatibility tests
For companies, becoming familiar with the requirements of this standard early helps avoid later compliance risks and makes products better suited to core settings such as healthcare and disease control
For biosafety cabinet manufacturers, studying and becoming familiar with the requirements of GB 41918-2022 in advance not only effectively avoids compliance risks after the standard takes effect and ensures smooth market entry, but also drives improvements in product performance and quality, enabling products to meet the demanding needs of core applications such as healthcare and disease control more precisely and enhancing their market competitiveness.
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