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IEC 60601-2-2:2017 RLV ed6.0

Действует
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 — 278 стр.
IEC 60601-2-2:2017 RLV contains the International Standard and its Redline version. The Redline version is available in English only. The Redline version provides you with a quick and easy way to compare all the changes between this standard and its previous edition. The Redline version is not an official IEC Standard, only the current version of the standard is to be considered the official document.

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.
ICS
11.040.30 Surgical. Including surgical dressings, sutures, etc. / Хирургические инструменты и материалы. Включая перевязочные, шовные и другие материалы