IEC 60601-2-3 , “Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment,” has just been revised and the new Edition 3.0 is available from Document Center Inc. The 46-page IEC 60601-2-3:2012 specifies the requirements for the basic safety and essential performance of short-wave therapy equipment.
Short-wave therapy equipment are defined as medical equipment for the therapeutic treatment of a patient by exposure to electric or magnetic fields produced in the frequency range of more than 13 MHz but not exceeding 45 MHz. Equipment having a rated output power not exceeding 10 W are exempted from certain requirements of this standard.
There is also an informative Annex AA which provides a “particular guidance and rationale” section giving some explanatory notes on specific sections. The standard states, “It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology.” The annex is not a requirement of the standard.
This third edition cancels and replaces the second edition of IEC 60601-2-3 published in 1991 and its amendment 1 published in 1998. It constitutes a technical revision and has been aligned with IEC 60601-1:2005.
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