IEC 60601-1:2006, the harmonized standard for medical electrical equipment

IEC 60601-1:2006, which is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries. The Third Edition of IEC 60601-1 will become the new standard requirement of all medical electrical equipment safety from the June 1, 2012 (mandatory adoption) in Europe and a year later in the United States. The IEC 60601-1 conformity standard consists of collateral standards designated IEC 60601-1-xx (where the xx represents a number). In addition, specific standards designated IEC 60601-2-xx (where the xx represents a number) exist to amend or clarify the basic standards as they relate to various types of electrical equipment used in the treatment of patients. The Third edition is very different from the Second 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. The FDA also recognizes the IEC 60601 with minor deviations. In order to more closely align the UL standard number with the IEC 60601, UL published the first edition of UL 60601-1 in April 2003 to replace UL 2601-1. For reference, the main differences between the IEC 60601-1 and the UL 60601-1 standard relate to: components, leakage currents, moving parts, oxygen, flammability, mains plug, power cords, and markings.


IIEC 60601-1:2006, the harmonized standard for medical electrical equipment