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Testing and certification for medical PPE products ensures they meet the regulatory requirements for their destination market.

Woman with Medical Mask

Personal protective equipment (PPE) is a mainstay of health and medical systems the world over. Providing a barrier between patients, medical staff and even members of the public, to help them avoid contact with blood and bodily fluids, or contaminated airborne particles, medical PPE must meet stringent safety requirements.

Many countries have PPE regulations and standards; there is little or no harmonization. At SGS, we have a global network of PPE experts and accredited testing laboratories that can help you bring products to market quickly and efficiently.

Which medical PPE products can SGS test and certify?

We have expertise across the category, but the most frequently requested items are:

Face masks

  • Reusable fabric masks – a fabric mask provides basic protection to members of the public in their everyday life
  • Medical face masks – also known as surgical and procedure masks, medical face masks protect the wearer’s face from contact with blood and other bodily fluids. They may be worn by medical staff, patients and others to reduce the risk of spreading infections
  • Respirators – commonly known as a filtering face piece, or a half mask, respirators have a tight facial fit and provide the wearer with protection against the inhalation of hazardous atmospheres and are very efficient for the filtration of airborne particles

Gloves

Disposable, single use protective gloves to that protect the wearer from contamination. We test items made from substances including:

  • Latex
  • Vinyl
  • Nitrile

Gowns

Disposable single use articles, or reusable garments, gowns protect the wearer from contact and contamination with blood and other bodily fluids.

Medical PPE requirements & regulations

As there are no harmonized standards, we offer in-depth expertise in the relevant standards for your target markets and can streamline your testing choices to ensure all compliance obligations are met efficiently. From Asia and Australia, to Europe and the Americas, we can help.

Why choose medical PPE testing & certification services from SGS?

Our global network of accredited PPE testing laboratories include two Notified Bodies approved to provide certification for EU type examination:

  • SGS Fimko – Notified Body (0598)
  • SGS United Kingdom Limited – Notified Body (0120)

Ensure the safety and quality of your medical PPE products – contact SGS today.

Woman with Medical Mask

Protective Face Masks

Because of COVID-19, face masks are now compulsory in many settings. Our testing & certification services verify their effectiveness and compliance to regulations.

Learn more