Accredited Compliance Reports
The most effective path to demonstrating compliance to the international safety and essential performance standards, used to place devices on the international market.
Includes equipment evaluation, required documentation review, device testing, and report, for demonstrating compliance to standards. The IECEE-published TRF (Test Report Form) is the international report format used to document compliance to IEC standards. These reports are typically referred to as Compliance Reports, CB Style Reports, or FDA 510(k) Testing Reports.
For medical devices, the report covers the IEC 60601-1 base standard, applicable Collateral and Particular standards, as well as national differences. See IEC 60601-1 National Differences list of standards.
For Laboratory Equipment, the report covers the IEC 61010-1 base standard and applicable Particular standards.