BS EN 60601-1:2006 is one of the essential standards to meet the requirements of the Medical Device Directive for sales of Medical Devices in the European Union. Entitled “Medical electrical equipment. General requirements for basic safety and essential performance,” the standard is identical in content to the IEC 60601-1 Edition 3.0 from 2005.
BS EN 60601-1 is for intended for use by manufacturers, regulation bodies, independent certification bodies and professional users and beneficiaries of medical electrical equipment.
The standard applies to medical electrical equipment intended to be used in the diagnosis, treatment, or monitoring of a patient. It focuses on the basic safety and essential performance of medical electrical equipment and medical electrical systems.
The standard is one of a group of standards in the 60601 series. For a complete listing of the IEC 60601 series documents, here is our Document Center page with the complete listing – http://www.document-center.com/iec_60601.cfm.
And here is a link to our page on all the documents that are part of the harmonized standards list for the Medical Device Directive.
You’ll find both pages useful in identifying the documents you need in order to meet Medical Device regulations globally. The standards are all available from Document Center Inc. on our website, www.document-center.com. Or call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.com). Your questions and comments are always welcome.
