Skip to main content
Back

EVS-EN IEC 60601-2-2:2018

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

General information

Valid from 04.06.2018
Base Documents
IEC 60601-2-2:2017; EN IEC 60601-2-2:2018
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.10.2024
Amendment
01.10.2024
Main + amendment
04.06.2018
Main
02.11.2011
Amendment
07.08.2009
Main
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.

Required fields are indicated with *

*
*
*
PDF
39.04 € incl tax
Paper
39.04 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN 60601-2-18:2015

Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Newest version Valid from 04.11.2015
Main

EVS-EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Newest version Valid from 02.10.2020
Main + amendment

EVS-EN 60601-1-2:2015+A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + IEC 60601-1-2:2014/A1:2020)
Newest version Valid from 01.04.2021
Main

EVS-EN IEC 80001-1:2021

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Newest version Valid from 15.11.2021