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IEC 60601-2-2:2017 ED6

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
21. 2. 2023.

Опште информације

60.60     31. 3. 2017.

IEC

TC 62/SC 62D

Међународни стандард

11.040.30  

енглески   француски  

Куповина

Објављен

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Апстракт

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.

Животни циклус

ПРЕТХОДНО

ПОВУЧЕН
IEC 60601-2-2:2009 ED5

ПОВУЧЕН
IEC 60601-2-2:2009/COR1:2014 ED5

ТРЕНУТНО

ОБЈАВЉЕН
IEC 60601-2-2:2017 ED6
60.60 Стандард објављен
31. 3. 2017.

ИСПРАВКЕ / ИЗМЕНЕ

ОБЈАВЉЕН
IEC 60601-2-2:2017/AMD1:2023 ED6

Национална преузимања

Elektromedicinski uređaji – Deo 2-2: Posebni zahtevi za osnovnu bezbednost i bitne performanse visokofrekvencijskih hirurških uređaja i visokofrekvencijskog hirurškog pribora

60.60   Стандард објављен