Test Reports

Bacterial Filtration Efficiency(BFE)

≥ 95% (Type I) &

≥ 98% (Type II)

Summary of test results

Materials compliant with Type I and IIR limits

Tested by

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Breathability and Particle Penetration

<40 Pa/cm²

Summary of test results

Materials met required performance properties and are validated to make claims for surgical mask type

Tested by

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Microbial Cleanliness test

≤ 30 cfu/g

Summary of test results

Finished face masks meet the performance for Type I and Type II

Tested by

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Filter Reuse Test Report

Retained particle filtration efficiency of

≥ 95% for up to 12 disinfection cycles

Summary of test results

The results showed that the masks retained Type I particle filtration efficiency of ≥ 95% for up to 12 disinfection cycles.

Tested by

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Splash resistance requirement for artificial blood

Splash resistance pressure (kPa)

≥ 16 – TYPE IIR

Summary of test results

Resistant against penetration by synthetic blood – ISO 22609:2004

Tested by

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Bacterial Filtration Efficiency(BFE)

≥ 95% (Type I) &

≥ 98% (Type II)

Summary of test results

Materials compliant with Type I and IIR limits

Tested by

Download report

Breathability and Particle Penetration

<40 Pa/cm²

Summary of test results

Materials met required performance properties and are validated to make claims for surgical mask type

Tested by

Download report

Microbial Cleanliness test

≤ 30 cfu/g

Summary of test results

Finished face masks meet the performance for Type I and Type II

Tested by

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Filter Reuse Test Report

Retained particle filtration efficiency of

≥ 95% for up to 12 disinfection cycles

Summary of test results

The results showed that the masks retained Type I particle filtration efficiency of ≥ 95% for up to 12 disinfection cycles.

Tested by

Download report

Splash resistance requirement for artificial blood

Splash resistance pressure (kPa)

≥ 16 – TYPE IIR

Summary of test results

Resistant against penetration by synthetic blood – ISO 22609:2004

Tested by

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License and Certificates

License to Manufacture Medical Devices

The Stellenbosch Nanofiber Company has been authorised to manufacture, pack, label, service, and export medical devices

Issued by

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ISO 13485:2016

The Stellenbosch Nanofiber Company has demonstrated to third-party regulators that it complies with the following standards:

ISO 13485:2016

Issued by

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ISO 9001:2015

The Stellenbosch Nanofiber Company has complied with the requirements set forth in the ISO 9001:2015

Issued by

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License to Manufacture Medical Devices

The Stellenbosch Nanofiber Company has been authorised to manufacture, pack, label, service, and export medical devices

Issued by

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ISO 13485:2016

The Stellenbosch Nanofiber Company has demonstrated to third-party regulators that it complies with the following standards:

ISO 13485:2016

Issued by

Download Certificate

ISO 9001:2015

The Stellenbosch Nanofiber Company has complied with the requirements set forth in the ISO 9001:2015

Issued by

Download Certificate