Test Reports

Bacterial Filtration Efficiency (BFE)

Submicron particulate filtration efficiency (PFE)

Differential Pressure (Breathability)

Splash resistance (Resistance to penetration by synthetic blood)

Microbial cleanliness (Bioburden)

Filter Reusability

Type I

≥ 95%

≥ 95%

< 40 Pa/cm²

≥ 80 mm Hg

≤ 30 cfu/g

≥ 95% after 10 wash cycles

Type IIR

≥ 98%

≥ 98%

<40 Pa/cm²

≥ 16 kPa (120 mm Hg)

≤ 30 cfu/g

≥ 98% after 10 wash cycles

Tested by

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Type I Report
Type IIR Report
Type I Report
Type IIR Report
Type I Report
Type IIR Report
Download report
Type I Report
Type IIR Report

Bacterial Filtration Efficiency (BFE)

Type I

≥ 95%

Type IIR

≥ 98%

Tested by

Download report

Submicron particulate filtration efficiency (PFE)

Type I

≥ 95%

Type IIR

≥ 98%

Tested by

Type I Report
Type IIR Report

Differential Pressure (Breathability)

Type I

< 40 Pa/cm²

Type IIR

<40 Pa/cm²

Tested by

Type I Report
Type IIR Report

Splash resistance (Resistance to penetration by synthetic blood)

Type I

≥ 80 mm Hg

Type IIR

≥ 16 kPa (120 mm Hg)

Tested by

Type I Report
Type II Report

Microbial cleanliness (Bioburden)

Type I

≤ 30 cfu/g

Type IIR

≤ 30 cfu/g

Tested by

Download report

Filter Reusability

Type I

≥ 95% after 10 wash cycles

Type IIR

≥ 98% after 10 wash cycles

Tested by

Type I Report
Type IIR Report

License and Certificates

License to Manufacture Medical Devices

SNC is authorised to manufacture, pack, label, service, and export medical devices

Issued by

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ISO 13485:2016

SNC’s QMS is certified to the international standard for the Good Manufacturing Processes of Medical Devices

Issued by

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ISO 9001:2015

SNC’s QMS is certified to the international standard for quality management systems

Issued by

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License to Manufacture Medical Devices

SNC is authorised to manufacture, pack, label, service, and export medical devices

Issued by

Download License

ISO 13485:2016

SNC’s QMS is certified to the international standard for the Good Manufacturing Processes of Medical Devices

Issued by

Download Certificate

ISO 9001:2015

SNC’s QMS is certified to the international standard for quality management systems

Issued by

Download Certificate