Covering requirements for basic safety and essential performance, IEC 60601 is a globally accepted standard for medical electrical equipment. As a leading provider of medical device testing, we help you ensure that your products are safe, reliable, and certified for use in international markets.

IEC 60601 covers electronic medical devices and healthcare products, including diagnostic equipment, home health products and specialty devices. In addition to its use as harmonized standard for several CE marking directives, FDA and CSA, IEC 60601 has also been adopted by  other governing bodies across the globe as part of their national certification programs.

Our IEC 60601 Testing Services

As a CBTL and ISO17025 certified body, Element offers a wide range of accredited testing services for IEC 60601 requirements. Our experts can assist in determining which standards apply to your product and certification requirements including providing project management and overall guidance on approval requirements. Some of the testing we provide to support IEC 60601 certification include:

Implantable Device Testing

Medical Device Battery Testing

EMC Testing

Medical Device Safety Testing

Medical Device Wireless Testing

Medical Device Directive (MDD)

Software validation

Usability

Wireless Co-existence

Additional safety testing services

In addition to IEC 60601, we provide product safety testing for a wide scope of medical devices, including orthopedic implants, cardiac devices and more. Our Certification team provides the Certification Services required for Market Access for North America, Japan and Korea as well as Notified Body Services for Europe

As a Certification Body Test Laboratory under the National Certification Body (NCB) scheme, we can test and certify your electrical products to the IECEE certification scheme, which has significant market access advantages.

Element's Global Approvals team provide further services to help those looking to export their products into the Global Market place.

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