Regulatory Requirements for Face Shields and Safety Googles

Face shields and safety goggles are an important category of personal protective equipment (PPE) for healthcare workers. They protect the eyes and face from liquid splashes that could be an infection pathway for COVID-19 or other viruses.

There are different regulations and requirements for these products in different parts of the world. We’ve outlined some of the key details for the U.S. and Europe/UK markets.

United States

In the U.S., these products are regulated by the Occupational Safety and Health Administration (OSHA), under 29 CFR 1910. 33. In addition, face shields are considered a Class 1 Medical Device, if they are intended to prevent the spread of disease.

For the U.S. market, the applicable testing standard is ANSI Z87.1. Certification is optional in the U.S.

Europe and UK

In Europe, these products are covered under PPE Directive (EU) 2016/425 and considered PPE Category II, which requires a CE mark and assessment by a Notified Body in Europe and/or in the UK (for the UK, the UKCA mark is required in place of the CE mark).

We test these products to EN 166, and then the test data is reviewed by an approved Notified Body, who confirms that the products meet the requirements of the PPE regulation, before certifying the products as compliant.

Testing Parameters

The testing standards for both of these markets cover the same basic parameters:

• Visibility – ensure the user can see clearly whilst wearing the face shield or safety goggles
• Fit and Comfort – ensure the product is comfortable to wear
• Protection from Splashes – ensure the product safely covers the required area of the face to protect from liquid splashes and droplets
• Impact Resistance – ensure the product will not crack or break if impacted in an unforeseen way