Understanding and meeting the regulations relevant to your PPE products in all of your target markets can be especially difficult during a time of crisis. It requires both technical expertise and industry know-how to navigate regulatory complexities and bring your PPE products to market quickly.
We evaluate PPE and apparel to the industry’s standards for safety and performance, including regulations and guidelines provided by the World Health Organization COVID-19 Operational Support and Logistics Disease Commodity Packages, the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA) and the European Commission. We test and certify a wide range of PPE products including:
- Protective goggles and face shields, aka eye protection, which are intended to mainly protect the user’s eye or facial area from emitted droplets to ANSI Z87.1 in North America and to EN 166 for Europe
- Isolation gowns, surgical gowns and drape protection for healthcare providers to ANSI/AAMI PB70 for North America
- Partnering with external labs to test medical gloves, which are intended to protect the wearer from contaminants during medical examination and diagnostic procedures, to ASTM D6319 in North America
- Partnering with external labs to test filtering facepiece respirators, also known as respirators, N95 respirators or particle-filtering half masks (FFRs) to 42 CFR Part 84 (N95) and 21 CFR 878.4040 in North America and to EN 149 for Europe
- Surgical masks, nonsurgical masks and nonmedical masks
Our global solutions for both North America (UL Mark) and Europe (CE Mark) help you demonstrate compliance with PPE standards. We will help you understand the guidelines and regulations applicable to your PPE products, test products to determine compliance, and offer document review for COVID-19 products certified in another country. For new product types in consideration, we can support you with the necessary regulatory, technical and testing advice – including 3D printing considerations – that can help you bring innovative products to market quickly.
Our goal is to help you to quickly meet the current critical needs for PPE with trustworthy products, helping you deliver both protection and peace of mind to your customers.