IEC 60601-2-2:2017
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition:- refinement and additions to the defined terms;- additional separation of the requirements for HF surgical equipment and HF surgical accessories;- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;- new requirements for devices that have or use a high current mode.
IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.
HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.
The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
- refinement and additions to the defined terms;
- additional separation of the requirements for HF surgical equipment and HF surgical accessories;
- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;
- new requirements for devices that have or use a high current mode.
IEC 60601-2-2:2009 specifies particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This fifth edition cancels and replaces the fourth edition published in 2006. This edition constitutes a technical revision. Revisions in this edition include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibility testing and correcting some of the equations used in deriving the thermal test for neutral electrodes. The contents of the corrigendum of February 2014 have been included in this copy.
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