Warner Power Announces Compliance with UL 60601-1 & IEC 6061-1 (3rd Edition) for Medical Device Safety
Warner Power has announced that its medical grade electronic ballast products for Xenon lamps from 75W to 300W have been approved by UL in conformance to UL 60601 & IEC 60601 (3rd edition). IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries. In addition to safety requirements, the standard includes specific requirements for functional safety, software, lasers and EMC.
The 3rd edition of IEC 60601 is being adopted by countries and public health organizations globally. The 3rd edition is very different than the 2nd edition in that in order to show product conformance, it requires a risk management file and process conforming to ISO 14971, the international standard for Application of Risk Management to Medical Devices.