Kiwa expands IECEE scope with electrical safety testing for medical devices
Kiwa Netherlands has expanded its IECEE scope with electrical safety testing for medical equipment. This strengthens Kiwa’s position as a partner for manufacturers that want to bring medical products to the international market. In addition to the existing accreditation for EMC testing in accordance with the CB scheme, Kiwa can now also assess the electrical safety of medical equipment.
The extension falls under the IECEE CB scheme, part of the IECEE system of the International Electrotechnical Commission (IEC). Within this system, CB stands for Certification Body, the organization that issues certificates based on test results from recognized laboratories, CBTLs. The CB scheme enables products to be tested according to harmonized IEC standards and for the results to be accepted internationally.
This means that in the Netherlands Kiwa can now test and certify medical devices for both safety and electromagnetic compatibility (EMC) within one integrated process. This offers clear benefits for manufacturers. Because CB test reports and certificates are accepted worldwide, access to international markets is accelerated and additional testing is often not required.
In addition, combining safety and EMC under one roof leads to shorter lead times and fewer handover moments between parties. This results in a more efficient process and helps reduce certification costs. Another key advantage is that manufacturers can rely on a single partner throughout the entire process. From testing to certification, they are supported by specialists with in depth knowledge of standards and regulations for medical devices.
With this extension, Kiwa underlines its ambition to be a one stop shop for manufacturers looking to develop and bring safe, compliant and internationally accessible medical products to market.
More information
For more information, please visit the IECEE website.
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