F2 Labs: IEC 60601-1 Testing & Certification
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Guarantee the electrical safety and performance of medical devices with F2 Labs’ IEC?60601?1 testing. We verify compliance of medical electrical equipment—covering insulation, leakage current, and software risk controls—to meet global healthcare market requirements.
IEC 60601-1 3rd edition contains a shift in thinking from the previous edition. There is more emphasis on the risk management file and process conforming to ISO 14971, as well as essential performance. We can assist you through this process.
Certain aspects of safety and performance are defined by the collateral standards (numbered 60601-1-X). The revision dates for the Collaterals and Particulars standards may not be the same as that of the General Standard.
In addition to IEC 60601-1, which is the general Safety standard for Medical Devices, we can also assist you with the part 2 product-specific standards: IEC 60601-1-11 for home healthcare equipment; IEC 60601-1-6 for usability; IEC 60601-1-8 for alarms; Risk Assessment to ISO 14971; and more.
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