Coveralls, Gowns and Shoe Covers:

Testing and Certifications

Surgical drapes and gowns, both single-use and reusable, serve as a critical barrier to prevent the transmission of infectious agents between healthcare personnel and patients during invasive procedures. In compliance with the technical requirements of EN 13795-1 and EN 13795-2 standards, we test and validate the performance of these devices to ensure safety and sterility in the operating theatre.

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Contact a CIMAC Consultant. Book a 15-minute slot with a technician.

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.

Gowns must pass rigorous tests for liquid penetration resistance, microbial cleanliness, and particle release (linting).

We distinguish between “Standard Performance” and “High Performance” based on the criticality of the procedure and the probability of fluid exposure. We support you in verifying these technical parameters to ensure the protection of both the medical team and the patient in the shortest possible time.

Unlike gowns, clean air suits (shirt, trousers, and potential shoe covers) are intended to minimise the dispersal of skin scales into the operating theatre air, limiting environmental contamination.

We perform tests on the breaking strength and microbial barrier of the fabrics used. We offer constant support to validate the effectiveness of these work garments in the shortest possible time.

Drapes, intended to cover the patient or equipment, are tested for their liquid absorption or repellency capacity and for mechanical resistance under stress.

Compliance with the EN 13795-1 standard ensures that the drape maintains a barrier against infectious agents throughout the invasive procedure. We guarantee dedicated technical assistance to certify the reliability of your devices quickly.

Yes, but with additional requirements: for reusable garments, it must be demonstrated that protective performance and material integrity remain unchanged after the declared washing and sterilisation cycles.

We verify that requirements are maintained after the stress of repeated treatments, supporting you in validating maintenance protocols to achieve compliance in the shortest possible time.

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