Compliance for UL60601 V3.1 In The North American Market

As we head into 2018, Onyx Healthcare USA is proud to announce it’s in full compliance with the 3.1 version of the UL60601 medical safety regulations. The safety of our consumers is and has always been our number one priority. Which is why we strive to consistently be at the forefront when it comes to high standards for medical equipment.

The UL is designed to build trust in the safety, sustainability, and security of medical products across the globe. UL helps confirm compliance and maintain a transparency between companies and their customers through its certification programs.

This year, the UL has made some serious adjustments to the UL60601 versions of the past. Version 3.1 addresses and more clearly defines risk management principles, requires essential performance, and mandated usability engineering evaluations, and requires a formal life cycle development for software.

Other changes to the American UL60601 V3.1 include new product labeling, strict documentation requirements, and technical specifications for electrical and mechanical hazards.

Not only does the product itself require compliance with a wide variety of regulations to become UL certified. The process and facility in which the product is made also undergo rigorous evaluation.

Onyx Healthcare has been a leader in medical supplies for both the European market and the North American market. We consistently provide high-quality medical equipment backed by certification. Every Onyx product in mass production is compliant with the new version 3.1 of the EN/UL60601 regulations.

Choose Onyx Healthcare USA for all of your medical equipment needs. We offer a wide variety of products ranging from mobile cart computing solutions to mobile medical assistants and ubiquitous power solutions.

Want to learn more about Onyx Healthcare USA or need a quote? Contact our American Headquarters at (714) 792-0774 today. One of our friendly representatives will be happy to help.

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