IEC 60601-1:2012 pdf free download.Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
Aware of the need and the urgency for a standard covering electrical equipment used in medical practice, the majority of National Committees voted in 1977 in favour of the first dition of IEC 60601-1, based on a draft that at the time represented a first approach to the problem. The extent of the scope, the complexity of the equipment concerned, and the specific nature of some of the protective measures and the corresponding tests for verifying them, required years of effort in order to prepare this first standard, which can now be said to have served as a universal reference since its publication.
However, the frequent application of the first edition revealed room for improvement. These improvements were all the more desirable in view of the considerable success that this standard has enjoyed since its publication.
The careful work of revision subsequently undertaken and continued over a number of years resulted in the publication of the second edition in 1988. This edition incorporated all the improvements that could be reasonably expected up to that time. Further developments remained under constant study. The second edition was amended in 1991 and then again in1995.
The original lEC approach was to prepare separate BASIC SAFETY and performance standards for MEDICAL ELECTRICAL EQUIPMENT. This was a natural extension of the historical approach taken at the national and international level with other electrical equipment standards，where BASIC SAFETY is regulated through mandatory standards but other performance specifications are regulated by market pressure. In this context, it has been said that, “The ability of an electric kettle to boil water is not critical to its safe use”.
It is now recognized that this is not the situation with many items of MEDICAL ELECTRICAL EQUIPMENT, and RESPONSIBLE ORGANIZATIONs have to depend on standards to ensure ESSENTIAL PERFORMANCE as well as BSSIC SAFETY.Such areas include the accuracy with which the equipment controls the delivery of energy or therapeutic substances to the PATIENT, or processes and displays physiological data that will affect PATIENT management.
This recognition means that separating and performance is somewhat inappropriate in addressing the HAZARDS that result from inadequate design of MEDICAL ELECTRICAL EQUIPMENT. Many particular standards in the EC 60601-2-x series address a range of ESSENTIAL PERFORMANCE requirements that cannot be directly evaluated by the RESPONSIBLE ORGANIZATION without applying such standards.