Amendment to medical standard
Reducing risk through standardization
The safety and performance of ME (medical electrical) equipment and systems are central to the management of risks in the medical environment. IEC TC (Technical Committee) 62 and its SCs (Subcommittees) prepare International Standards for this area of technology. An amendment to the general requirements for basic safety and essential performance of ME equipment and systems has just been released as an FDIS (Final Draft International Standard) document.
Standards for all types of medical electrical equipment
IEC TC 62: Electrical equipment in medical practice, and its SCs have been preparing standards for ME equipment and systems for decades. The 60601 series of International Standards detail both general and more specific requirements for all types of ME equipment and systems: from magnetic resonance equipment to radiotherapy simulators and X-ray equipment for diagnostics or computer tomography, to name just a few.
Comprehensive revision for major standard
SC 62A: Common aspects of electrical equipment used in medical practice, has just published an amendment to IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. This comprehensive document updates and replaces a number of parts of the current standard, adding the latest information for manufacturers and users.
The object of IEC 60601-1 is to specify general requirements and to serve as the basis for specific standards. This International Standard details general and test requirements; the classification, equipment identification, marking and documents of ME equipment and systems; protection against electrical and mechanical hazards, against unwanted and excessive radiation hazards and against excessive temperatures and other hazards from ME equipment and systems.
IEC 60601-1 also provides information on PEMS (programmable electrical medical systems) and advice to manufacturers about addressing the risks associated with the accuracy of controls and instruments.
In the IEC 60601 series, some standards may modify, replace or delete requirements contained in IEC 60601-1 as appropriate for the particular ME equipment under consideration, and may add other basic safety and essential performance requirements.
Yes to VAPs!
This amendment can be purchased immediately from the IEC webstore as an FDIS.
FDIS are pre-release documents available during the approval stage; that is, for a two-month voting period. If the document is approved, it progresses to final publication stage. The International Standard is then published within six weeks of FDIS approval.
Once this document is officially published, a consolidated version of IEC 60601-1, including the amendment, will be immediately available for anyone who would like to purchase a convenient all-in-one product.
The FDIS and the Consolidated version are two of the VAPs (Value Added Products) derived from official publications that are available through the IEC webstore.