The International ICE 60601-1 standard and its 3rd revision regarding the safety and effectiveness of medical electrical equipment are of crucial importance to the manufacturers of such medical devices. More so since the 3rd revision will come into force starting the 1st of June 2012.
First published in 1977, IEC 60601-1 represents a major revision of the IEC 60601 family of medical electrical equipment safety standards. This standard is part of the IEC 60601 series of technical standards for the safety and effectiveness of medical electrical equipment and acts as parent standard to over 60 other specific device standards.
The IEC 60601-1 was adopted as a European Harmonized Standard and its aim is to support the evidence of conformity in relation to Annex 1, point 12 of the MDD 93/42/EEC regarding the requirements for medical devices connected to or equipped with an energy source.
The 3rd edition of the internationally recognized standard IEC 60601-1 for electro-medical equipment safety was issued in 2005, but its adoption will become mandatory for the European Market starting 1st of June 2012.
The most important contribution of this 3rd revision concerns the manufacturers of electro-medical equipment and systems which should have a formal risk management system in place in order to comply. Moreover, this risk management process must address the entire life cycle of the medical device, not just the design phase.
The definition of medical electrical equipment was also revised in line with the scope of the MDD 93/42/EEC to add ‘or compensation or alleviation of disease, injury or disability’. Until this addition, medical electrical equipment was limited to devices intended by their manufacturer to ‘diagnose, treat or monitor a patient’.
These requirements should apply to medical devices which have electrical components or electrical features and which fall under the scope of one of these directives: Medical Device Directive 93/42/EEC, IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) and AIMDD (Active Implantable Medical Device Directive) 90/385/EEC.
It is important to remember that medical devices exported to Europe need to bear the CE marking affix which ensures a commonly accepted safety standard and non-EU manufacturers of medical devices must appoint a European Authorized Representative, acting as the legal identity of that manufacturer towards the European Authorities.