Mechanical Testing for Medical Face Masksss

Mechanical testing of Face Masks

1. Face Masks Testing

2. The Importance of PPE Testing

3. Face Mask Components Tests Face Mask Components Test Requirements Test Standards Axial tensile of breathing valve cover (10N, 10S or 50N, 10S), firmness of head band and mask body, axial tensile of connecting parts No slippage, break, or deformation - GB 2626-2019 Respiratory protection - Non-powered air-purifying particle respirator. - EN 149:2001 - Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions Breaking strength of the connecting point between the mask band and the mask body No less than 10 N - GB 19083 Protective Face Mask '- EN 149:2001 - Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions Breaking strength of the mask band and the joint between the mask band and the mask body No less than 20 N - YY/T 0969-2013 - GB 19083-2010 - Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions Breathing valve cover fastness (10 N for 10 s） No slippage, break or deformation - YY/T 0969-2013 - GB 19083-2010 - Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions Breaking strength of mask band No less than 10 N - YY 0469-2011 - GB 19083-2010 - Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions Mask band static tensile strength No less than 10 N YY/T 0969-2013 Non-woven Mask Fabric Maximum and Break Strength & Elongation (Machine Direction & Cross Direction) Tensile Tests for Fabric: GB/T 24218.3-2010 Part 3 ASTM D5034-09 ISO 9073-3:1989

4. Technical Requirements for Medical Protective Masks - China Classification Standard Number Standard Name Test items Medical Masks GB 19083-2010 Technical requirements for medical protective masks Mask band YY 0469-2011 Medical surgical mask Mask band YY/T 0969-2013 Disposable medical mask Mask band Civil protective mask GB 2626-2019 Breath protection Expiratory valve protection Headband Connections and connecting parts GB/T 32610-2016 Technical specifications of daily protective masks 口罩带连接强力 呼气阀盖牢度 Civil sanitary mask T/CNTAC 55-2020 T/CNITA 09104-2020 Civil sanitary mask Civil sanitary mask R aw material GB/T 30923-2014 Plastic Polypropylene (PP) melt blown material Melt mass flow rate GB / T 3682-2000 Method B FZ/T 64034-2014 Spunbond / meltblown / spunbond (SMS) method nonwoven fabric GB / T 24218.3 strip method

5. Single Use Surgical Mask Tests - Worldwide

6. Medical Surgical Mask Tests - Worldwide

7. Respirator Mask Tests - Worldwide

8. GB 19083-2010 Technical Requirements for Protective Face Mask for Medical Use Detection method: Through visual inspection and tensile test device measurement, the breaking strength of the connection point between each mask band and the mask body should not be less than 10N. Mask Elastic Strap Test Requirements: Sample Quantity & Processing: Take 4 masks and open package (2 are temperature pre-treated and 2 are not pre-treated. Temperature pretreatment conditions: a) Place in environmental test chamber at 70 ℃ ± 3 ℃ for 24h; b) Place in environmental test box at -30 ℃ ± 3 ℃ for 24h. After temperature pretreatment, restore at room temperature for at least 4h.

9. YY 0469-2011 Surgical Mask YY/T 0969-2013 Disposable Medical Mask The breaking strength of the connection point between each mask band and mask body should not be less than 10N Number of samples: 3 samples Detection method: Measure with a static tension of 10N for 5s

10. GB 2626-2019 Respiratory Protection Non-Powered Air-purifying Particle Respirator Static Test related test items: 5.6.2 Exhalation valve protection device 5.9 Headband 5.10 Connections and connecting parts Equipment requirements: 0-1000N, accuracy is 1%; or choose standard weight suspension method Timer accuracy: 0.1s

11. GB 2626-2019 Respiratory Protection - Non-powered air-purifying particle respirator Exhalation Valve Protector The exhalation valve protection device shall not slip, break and deform when subjected to the axial tension specified in Table 5. Quantity: 3 untreated respirator samples Test method: Use appropriate fixtures to fix the exhalation valve protector and mask body of the test sample (the fixing points should be reasonably close to the corresponding connection parts). Start the material testing machine, or by hanging a standard weight, apply an axial tensile force of 10N for 10s, and record whether there are fractures, slippage, and deformation. Similar: EN 149:2001+A1:2009 “Respiratory protective devices – Filtering half masks to protect against particles –. Requirements, testing, marking” Axial Tension Specified: Disposable Facepiece 10 N for 10 sec Replaceable Facepiece 50 N for 10 sec

12. GB 2626-2019 Respiratory Protection - Non-powered Air-purifying Particle Respirator Head Harness Each head harness, buckle and other adjustment parts of a respirator should not slip or break when subjected to the pulling force specified in Table 7. Quantity: Two samples, one untreated sample, other is a sample after pretreatment. Test method Fix the headband (non-free end) and mask body of the sample to be tested with a fixture (should be reasonably close to the corresponding headband buckle connection site). Start the material testing machine, or hang the standard weight, apply the pulling force specified in Table 7 according to the direction in which the headband is stretched during normal use, and record whether it appears Axial Tension Specified: Disposable Facepiece 10 N for 10 sec Replaceable Facepiece 50 N for 10 sec Full Facepiece 150 N for 10 sec

13. Connections and Connecting Parts Under specified test conditions, all connections and connecting parts between the replaceable filter element and facepiece or between the breathing tube and the filter element and the facepiece shall not slip, fracture or deform when subjected to the axial tension specified in Table 8. Quantity: Two samples, one an untreated sample, other is a sample after pretreatment. Test method: Fix the connecting parts and mask body of the tested sample with appropriate fixtures (the fixing points should be reasonably close to the corresponding connecting parts). Start the material testing machine, or apply the axial tensile force specified in Table 8 by hanging a standard weight, and record whether there is slippage, breakage or deformation. Each connection and connecting part of the tested sample should be tested separately and the results recorded. GB 2626-2019 Respiratory Protection - Non-powered Air-purifying Particle Respirator Axial Tension Specified fro Connections & Connectng Parts: Replaceable Half Facepiece 50 N for 10 sec Full Facepiece 250 N for 10 sec

14. GB/T 32610-2016 Technical Specifications of Daily Protective Masks Strap and the connection between the strap and the mask body - rupture strength must be ≥20N Quantity: 5 mask samples Per GB / T 13773.2 Stretching speed 100 mm / min Test hook of steel material, strip

15. GB/T 32610-2016 Technical specifications of daily protective masks Exhalation Valve Cover Fastness Samples and pretreatment: 3 untreated samples Test Equipment: 0 - 1000N, accuracy is 1% Timer accuracy is 0.1s Test: Fix exhalation valve cover and mask body of the test sample with appropriate fixtures (the fixing points should be reasonably close to the corresponding connection parts). Start the material testing machine and apply an axial tensile force of only 10N for 10s, and record whether there are fractures, slippage and deformation.

16. T/CNTAC 55-2020 & T/CNITA 09104-2020 Civil Sanitary Masks Requirement: Adult / Children Masks: Strength of the connection between mask band (harness) and mask body (face piece) must be ≥5N Number of samples: 3 samples Test: Test all the connection parts of the mask belt and mask body, take a single test, perform according to the provisions of GB / T 13773.2, and the stretching speed is 100mm / min. The mask band is clamped on the upper clamp of the tensile instrument, and the mask body is clamped in the middle of the lower clamp in the axial direction, flexible clamping.

17. FZ/T 64034-2014 Spunbond / Meltblown / Spunbond (SMS) Nonwoven Fabric For spunbond / meltblown / spunbond (SMS) fabric materials Technical requirements for non-woven fabric, test methods, inspection rules, packaging, labeling, storage and transportation Breaking strength & elongation at break are implemented per GB/T 24218.3 Nonwoven Textiles - Test methods - Part 3. breaking strength and elongation measurement (strip method)

18. GB/T 24218.3-2010 Textiles Non-Woven Fabric Test Method GB/T 24218.3-2010 Part 3 Determination of breaking strength and elongation at break (Strip Method) ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) ISO 9073-3:1989. Textiles — Test methods for nonwovens Part 3: Determination of tensile strength & elongation ISO 9073-3:1989

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