Testing and Certification Support for Medical PPE and Protective Equipment

Personal protective equipment only works if it performs to the standard it claims, and itmad provides testing and certification support for medical PPE and protective equipment: masks, respirators, gloves, gowns, eye protection and safety footwear, against EN, ASTM and ISO standards. 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 sale. itmad operates across the Middle East, Asia and Europe. Last reviewed: October 2026.

Products tested

Surgical and medical masks are tested for bacterial filtration efficiency, differential pressure, splash resistance, microbial cleanliness and biocompatibility, and classified by type against EN 14683 or ASTM F2100. Filtering facepiece respirators are tested for filter penetration, total inward leakage, breathing resistance and fit, to EN 149 for FFP classes or the equivalent N95 requirements. Latex, nitrile and vinyl examination and surgical gloves are tested for freedom from holes, dimensions, tensile properties and, where relevant, protein content, to the EN 455 series.

Surgical gowns and drapes are tested to EN 13795, and protective clothing against infective agents to EN 14126, covering barrier performance wet and dry. Goggles, visors and face shields are tested for optical quality, impact resistance and splash protection to EN 166, and protective footwear, high-visibility clothing and other PPE categories are 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. Markets differ in the conformity assessment route they require and in whether medical devices must also be registered, and for export to Europe, CE marking under the PPE Regulation or the Medical Device Regulation applies depending on classification, each with 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. itmad identifies which standards and which route apply to the client's 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, and a respirator worn to protect the wearer is PPE. Some products are both and are regulated under both regimes at once. Classification decides which standards apply, which conformity assessment route is available and whether registration is required, so getting it wrong at the outset invalidates the testing that follows.

How testing is arranged

Testing is coordinated through ISO/IEC 17025 accredited laboratories, and the report is 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, makes sure that 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 a market; healthcare providers verifying what they have been supplied; government and institutional buyers procuring at volume; exporters targeting European or other regulated markets; and buyers who have received product that does not match the sample.

Verification of existing certification

Certificates supplied with imported PPE are not always genuine or 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. itmad verifies test reports and certification back to the issuing body and confirms whether the evidence supports the claim being made.

What the client receives

The accredited laboratory's test report, issued under its own accreditation, with the standards, clauses and editions applied and a pass or fail result against each requirement tested. itmad also assesses whether the evidence satisfies the target market's requirements, reports verification findings where existing certification was in scope, and gives guidance on what further evidence a given market would require.

Frequently asked questions

Which PPE products does itmad test?

Surgical and medical masks, respirators, medical gloves, surgical gowns and protective clothing, eye and face protection, and safety footwear and other PPE. Testing is against the relevant EN, ASTM and ISO standards.

Is a surgical mask a medical device or PPE?

A surgical mask worn to protect the patient is a medical device, while a respirator worn to protect the wearer is PPE. Some products are both and are regulated under both regimes, and the classification decides the standards, the route and whether registration is required.

Why does the destination market matter?

PPE regulation is not harmonised, so the same product needs different evidence in different markets. Testing to the wrong standard for the intended market is the most common and most expensive mistake, because the work has to be repeated.

Which standards apply to masks and respirators?

Surgical and medical masks are classified against EN 14683 or ASTM F2100, and filtering facepiece respirators are tested to EN 149 for FFP classes or the equivalent N95 requirements. Gloves are tested to the EN 455 series, gowns to EN 13795 and eye protection to EN 166.

Can itmad verify certificates supplied with imported PPE?

Yes. itmad verifies test reports and certification back to the issuing body and confirms whether the evidence supports the claim made. Typical problems are a report against one standard presented as compliance with another, or a certificate that does not match the shipped product.

Who commissions medical PPE testing?

Manufacturers, importers and distributors, healthcare providers, institutional buyers and exporters targeting regulated markets. Buyers who have received product that does not match the sample also commission it.