IEC 60601-2-2:2017
Collections
International IEC standards
Publication date
March 2017
Number of pages
186 p.
Reference
IEC 60601-2-2:2017
IEC 60601-2-2:2017
March 2017
International standard
Current
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.
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Sumary
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.
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Replaced standards
(2)
IEC 60601-2-2:2009/COR1:2014
February 2014
International standard
Cancelled
Corrigendum 1 - 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 60601-2-2:2009
February 2009
International standard
Cancelled
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 60601-2-2:2009 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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The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.
The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.
With Requirements, quickly access the main part of the normative text!
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