Surgical Masks:

Testing and Certifications

Surgical masks are classified by their Bacterial Filtration Efficiency (BFE) and fluid resistance: Type I (BFE >> 95%) is intended for patients to reduce the spread of infections;Type II (BFE >> 98%) is designed for healthcare professionals in clinical settings; Type IIR combines high filtration (BFE >> 98%) with resistance to splashes of contaminated liquids. We perform the necessary tests to validate each category, providing technical assistance to achieve compliance in the shortest possible time.

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HOW CERTIFICATION WORKS

Certification process: from sample to certificate

A clear 5-step process, estimated timelines, and required documents to achieve CE marking.

  • 1) Pre-assessment:
    Product and standards; category I/II/III and modules (B; C2/D). Testing plan, checklist, and timelines.
  • 2) Sample Submission:
    Representative samples + Bill of Materials (BOM), instructions, and forms. Fast-track intake.
  • 3) Testing/Verification:
    Tests according to current standards. Clear updates; targeted corrections if required.
  • 4) Reporting:
    Test and evaluation report; ready for the DoC and Technical File.
  • 5) Certification / Surveillance:
    EU Type-Examination Certificate (Module B) valid up to 5 years; annual C2 or D surveillance (Cat. III). Retain DoC and Technical File for 10 years.
Frequently Asked Questions
Frequently Asked Questions (FAQ)

For over 40 years, CIMAC has been testing and certifying safety footwear (PPE) in accordance with Regulation (EU) 2016/425 and current harmonised standards (e.g., EN ISO 20345/46/47).

We cover the entire range: safety shoes, firefighter boots, chainsaw-resistant footwear, foundry and welding boots, electrically insulating boots, motorcycling footwear, and chemical protection. Clear pathways, sample checklists, and technical support through to CE marking.

Validity of Certifications and Document Retention

Retain the EU Declaration of Conformity and technical documentation for 10 years from the date the PPE is placed on the market. The EU Type-Examination Certificate (Module B) has a maximum validity of 5 years from the date of issue, unless the reference harmonised standard is revised. Module C2 and Module D are subject to annual surveillance.

To certify a surgical mask, we perform specific Bacterial Filtration Efficiency (BFE) tests, differential pressure (to measure breathability), and microbial cleanliness (Bioburden).

For Type IIR masks, we also verify resistance to splashes of contaminated liquids. We provide constant assistance in analysing results to ensure the product meets technical parameters in the shortest possible time.

A surgical mask is a Medical Device (MDR) designed to limit the spread of infectious agents from the wearer to the environment; an FFP2 respirator is a piece of PPE that protects the wearer by filtering inhaled air. We assist you in identifying the correct procedure based on the intended use, ensuring the necessary support for compliant marking in a short timeframe.

The Bioburden test determines the number of viable microorganisms present on the mask before sale. It is a critical parameter to ensure the safety of non-sterile products.

We analyse your samples in the laboratory to verify that the microbial load falls within EN 14683 limits, providing technical assistance to optimise production processes and achieve results in the shortest possible time.

The file must include the description of materials (e.g., meltblown and non-woven fabric), laboratory test reports, risk analysis, and labelling compliant with Regulation (EU) 2017/745. CIMAC reviews your technical documentation to prevent formal non-compliances that could delay market entry. Our goal is to guide you toward safe and fast certification.

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