When tested and used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and healthcare workers’ skin, mouth, nose or eyes. Testing and certifying for fluid, biological and chemical resistance helps assess whether PPE performs as expected to protect the safety of workers, patients and visitors against infectious microorganisms such as bloodborne pathogens.
UL Solutions, a global safety science leader, offers testing and certification services for healthcare PPE and apparel to requirements for North American and European (PPE Regulation requirements only) markets to help reduce the risk of contamination. These requirements are outlined in standards from the following organizations:
- American Society for Testing and Materials (ASTM) International
- Association for the Advancement of Medical Instrumentation® (AAMI)
- U.S. Food and Drug Administration (FDA)
- National Fire Protection Association (NFPA)
- International Organization for Standardization (ISO)
- European Standards (EN)
- United States Pharmacopeia (USP)
The importance of third-party conformity assessment and certification
Conformity assessment demonstrates that specified requirements relating to PPE products are fulfilled. Third-party conformity assessment is performed by a person or body independent of the organization providing the PPE and independent of user interests in that product. Third-party certification enhances trust and confidence that products comply with applicable safety requirements. During third-party certification, products are tested against safety standards by an independent accredited organization with objectivity without bias and are inspected and tested annually to confirm continued compliance.
Most medical PPE requires FDA approval. Additionally, some PPE products require third-party certification to achieve compliance with the relevant standards. For instance, NFPA 1999, Standard on Protective Clothing and Ensembles for Emergency Medical Operations, requires certification to specified requirements for emergency medical operations protective clothing used by emergency medical responders, medical first receivers and healthcare personnel. The standard covers emergency medical operations protective clothing, including garments, helmets, gloves, footwear and face protection devices.
We offer third-party conformity assessment and certification services for North America (UL Mark), United Kingdom (UKCA marking) and Europe (CE marking). In some cases, we can combine regional testing requirements, which can help manufacturers reduce costs, sample requirements and time to market. UL Solutions performs healthcare PPE testing and certification at FDA Good Laboratory Practice (GLP) compliant laboratories. Studies and testing are conducted in accordance with GLP Standards (GLPS), referenced in U.S. FDA 21 CFR 58.
Healthcare PPE testing and certification
UL Solutions offers a broad array of healthcare testing and certification services, including the following:
- Biological resistance testing – including penetration testing, as well as antimicrobial and antibacterial testing of fabrics and clothing.
- Chemical resistance testing – including chemical penetration and permeation testing of fabrics.
- Protective ensemble testing – such as testing face shields, full-body protection systems and clothing for chemical, vapor or liquid splash resistance.
- Protective hand and footwear testing – for gloves and shoes used in healthcare environments.
- Medical and surgical face mask testing – testing to confirm the masks will reduce the spread of airborne infectious diseases or the spread of diseases from bodily fluid transmission.
- Gown and drape testing – common tests include hydrostatic pressure and viral penetration testing on isolation gowns, surgical gowns, coveralls and drapes.
Why choose UL Solutions?
As a global safety science leader, UL Solutions leverages our decades of experience testing and certifying PPE to help manufacturers efficiently and cost-effectively navigate the world of regulatory compliance. Additionally, as a full-service testing, inspection and certification provider, UL Solutions offers a broad portfolio of services to help manufacturers meet industry and regulatory requirements. We offer a wide range of auxiliary services to help PPE manufacturers achieve efficient time to market while reducing costs.
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