Medical PPE Inspection & Testing

Personal protective equipment only works if it performs to the standard it claims. A surgical mask with inadequate bacterial filtration, a glove that fails a pinhole test, or a gown whose barrier breaks down when wet all look identical to compliant product on the shelf — which is why regulated markets require test evidence before the product can be sold.

Products tested

• Surgical and medical masksBacterial filtration efficiency, differential pressure, splash resistance, microbial cleanliness and biocompatibility, classified by type against EN 14683 or ASTM F2100.
• RespiratorsFiltering facepiece respirators tested for filter penetration, total inward leakage, breathing resistance and fit, to EN 149 for FFP classes or the equivalent N95 requirements.
• Medical glovesLatex, nitrile and vinyl examination and surgical gloves tested for freedom from holes, dimensions, tensile properties and, where relevant, protein content, to the EN 455 series.
• Protective clothing and gownsSurgical gowns and drapes to EN 13795, and protective clothing against infective agents to EN 14126, covering barrier performance wet and dry.
• Eye and face protectionGoggles, visors and face shields tested for optical quality, impact resistance and splash protection to EN 166.
• Safety footwear and general PPEProtective footwear, high-visibility clothing and other categories tested against the applicable EN and ISO standards.

Routes to market

PPE regulation is not harmonised, and the same product needs different evidence depending on where it is sold. For the UAE, regulated products require conformity assessment under the MoIAT schemes, and medical devices carry registration requirements with the Ministry of Health and Prevention. For GCC markets, G-Mark applies where the product falls within a regulated category. For export to Europe, CE marking under the PPE Regulation or the Medical Device Regulation applies depending on classification, and each has its own conformity assessment route.

The most common and most expensive mistake is testing to the wrong standard for the intended market, discovering it at registration, and repeating the work. We identify which standards and which route apply to your specific product and destination before testing is commissioned.

Medical device or PPE

Classification determines everything that follows. A surgical mask worn to protect the patient is a medical device; a respirator worn to protect the wearer is PPE; some products are both, and are regulated under both regimes simultaneously. The classification decides which standards apply, which conformity assessment route is available, and whether registration is required. Getting it wrong at the outset invalidates the testing that follows.

How testing is arranged

Testing is coordinated through ISO/IEC 17025 accredited laboratories, with reports issued by the laboratory under its own accreditation — which is what a regulator, a customs authority and a hospital procurement team will want to see. ITMAD identifies the applicable standards, specifies the test scope and sampling, ensures the laboratory is one the target regime accepts, and reviews the resulting reports against what registration or certification will require.

Who commissions this

• PPE and medical device manufacturers
• Importers and distributors bringing product into the UAE and GCC
• Healthcare providers verifying what they have been supplied
• Government and institutional buyers procuring at volume
• Exporters targeting European or other regulated markets
• Buyers who have received product that does not match the sample

Verification of existing certification

Certificates supplied with imported PPE are not always genuine, and not always what they appear to be — a test report against one standard presented as compliance with another, a certificate from a body with no standing for that product, or documentation that does not match the product actually shipped. We verify test reports and certification back to the issuing body, and confirm whether the evidence supports the claim being made.

What you receive

• The accredited laboratory's test report, issued under its own accreditation
• Identification of the standards and clauses applied, and their edition
• Pass or fail against each requirement tested
• Assessment of whether the evidence satisfies the target market's requirements
• Verification findings on existing certification, where that was the scope
• Guidance on what further evidence would be required for a given market