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EVS-EN IEC 60601-2-2:2018+A1:2024

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 + IEC 60601-2-2:2017/AMD1:2023)

General information

Valid from 01.10.2024
Base Documents
IEC 60601-2-2:2017; EN IEC 60601-2-2:2018; IEC 60601-2-2:2017/AMD1:2023; EN IEC 60601-2-2:2018/A1:2024
ICS Groups
11.040.30 Surgical instruments and materials
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.10.2024
Main + amendment
EVS-EN IEC 60601-2-2:2018+A1:2024
01.10.2024
Amendment
EVS-EN IEC 60601-2-2:2018/A1:2024
04.06.2018
Main
EVS-EN IEC 60601-2-2:2018
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
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.

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English (PDF 2 MB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English