T/JSAS 031-2022 One-time use respiratory filter
T/JSAS 031-2022 One-time use respiratory filter
Basic Information
Scope
Scope: This document specifies the terms and definitions, product classification, technical requirements, test methods, inspection rules, and packaging, marking, transportation, and storage for single-use respiratory filters. This document applies to single-use respiratory filters, which are intended to reduce the amount of particulate matter (including microorganisms) inhaled or exhaled by patients. Main technical content: 6. Test methods 6.1 Appearance: Visual observation shall comply with the provisions of 5.1. 6.2 Basic dimensions: Measurement with general measuring tools shall comply with the provisions of 5.2. 6.3 Filter removal rate: 6.3.1 Particle filtration removal rate shall be tested according to the method specified in Appendix A.2 of YY 0321.3-2009 and comply with the provisions of 5.3.1. 6.3.2 Bacterial filtration removal rate shall be tested according to the method specified in ASTM F2101 and comply with the provisions of 5.3.2. 6.4 Water loss: - Test method: Follow the method specified in YY/T 0735.1-2009, Section 6.2, and test under the corresponding test conditions specified in Table 2, and comply with the provisions of 5.4. 6.5 Pressure drop: - Test conditions: Test under the corresponding flow conditions specified in 5.5.1 and 5.5.2. - Test method: Use the test instrument specified in YY/T 0735.1-2009, Section 6.2.2, and follow the corresponding conditions specified in Table 2 for the intended application of the instrument. Conduct pre-adjustment processing before and 24 hours after processing. Test according to the method specified in YY/T 0735.1-2009, Section 6.3, and comply with the provisions of 5.5. 6.6 Leakage: - Test method: Follow the method specified in YY/T 0735.1-2009, Section 6.4, and comply with the provisions of 5.6. 6.7 Compliance: - Test method: Follow the method specified in YY/T 0735.1-2009, Section 6.5, and comply with the provisions of 5.7. 6.8 Ethylene oxide residue: - Test method: Conduct colorimetric analysis according to