Project Description

Testing Standards for Surgical Masks

At present, DQS HK is NOT providing product testing service, and the following information is for reference only.

ASTM F2100-19
ASTM F2100-19 Items Level 1 Level 2 Level 3
Barrier Testing BFE
ASTM F2101
≥ 95% ≥ 98% >= 98%
PFE
ASTM F2299
≥ 95% >= 98% >= 98%
Synthetic Blood
ASTM F1862, ISO22609
Pass at 80 mmHg Pass at 120 mmHg Pass at 160 mmHg
Physical Testing Differential Pressure
EN 14683
< 5.0 mm H2O/square cm < 6.0 mm H2O/square cm < 6.0 mm H2O/square cm
Safety Testing Flammability
16 CFR Part 1610
Class 1 (≥ 3.5 seconds) Class 1 (≥ 3.5 seconds) Class 1 (≥ 3.5 seconds)
Required samples Total for above tests Appx. 55 pcs Appx. 55 pcs Appx. 55 pcs
EN 14683:2019
EN 14683:2019 Items Type I Type II Type IIR
Barrier Testing BFE
Annex B
≥ 95% ≥ 98% >= 98%
Splash Resistance Pressure
ISO 22609
>= 16.0 K Pa
Physical Testing Differential Pressure
Annex C
< 40 Pa/square cm < 40 Pa/square cm < 60 Pa/square cm
Safety Testing Microbial Cleanliness
ISO 11737
<= 30 cfu/g <= 30 cfu/g <= 30 cfu/g
Required samples Total for above tests appx. 55 pcs appx. 55 pcs appx. 55 pcs
Biocompatibility tests against ISO 10993
Tests Standard
細胞毒  ISO 10993-5:2009
皮膚刺激(雙極)
致敏(雙極)
  ISO 10993-10:2010
Required Samples appx. 60 pcs
Bacterial Tests

For surgical masks, Bacterial Tests against GB15979-2002 may be considered, including:
Total Bacterial Count (細菌菌落總數), Coliforms (大腸菌群), Pseudomonas aeruginosa (銅綠假單胞菌), Staphylococcus aureus (金黃色葡萄球菌), Hemolytic streptococci (溶血性鏈球菌), Total Fungal Count (真菌菌落總數).

The required sample size is appx. 30 pcs in one box.

Note:  The Custom Dept of HK Government has implemented similar tests on the samples from the surgical masks in the market, according to Consumer Goods Safety Ordinance.

Note

Above information is for reference only and may not be up-to-date when you read it, which is not intended to be used for your decision making.

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ISO 13485 Certification
MDSAP
CE Marking

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