Back

EVS-EN 60601-1:2006/A2:2021

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)

General information

Valid from 01.11.2021
Base Documents
EN 60601-1:2006/A2:2021; IEC 60601-1:2005/A2:2020
ICS Groups
11.040.01 Medical equipment in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.05.2024
Main + amendment
EVS-EN 60601-1:2006+A1+A12+A2+A13:2024
01.11.2021
Amendment
EVS-EN 60601-1:2006/A2:2021
01.11.2021
Main + amendment
EVS-EN 60601-1:2006+A1+A12+A2:2021
02.03.2016
Main + amendment
EVS-EN 60601-1:2006+A1:2013+A12:2014
08.12.2006
Main + corrigendum
EVS-EN 60601-1:2006

EN 60601-1 kehtib elektriliste meditsiiniseadmete ja elektriliste meditsiinisüsteemide (EM-seadmete ja EM-süsteemide) esmase ohutuse ja oluliste toimimisnäitajate kohta. Põhitekst ja konsolideeritud versioon, mis koonseb põhitekstist ja muudatusest, on leitavad standardi ajaloost. EN 60601-1:2006/A2:2021 muudab Euroopa standardit EN 60601-1:2006

Standardimuudatuse EN 60601-1:2006/A11:2011 avaldamisest saadik on IEC alamkomitee kogunud eri allikatest aruteluteemasid, sealhulgas kommentaare rahvuslikelt komiteedelt, ja esitatud küsimusi. Komitee koosoleku aruteluteemasid on käsitletud selles standardimuudatuses.

Required fields are indicated with *

*
*
*
PDF
31.72 € incl tax
Paper
31.72 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Related products

Main + amendment

EVS-EN 60601-1:2006+A1+A12+A2:2021

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, modified + A1:2013 + A12:2014 + IEC 60601-1:2005/A2:2020)
Valid from 01.11.2021
Main + amendment

EVS-EN 60601-1:2006+A1+A12+A2+A13:2024

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + IEC 60601-1:2005/A1:2012 + IEC 60601-1:2005/A2:2020)
Newest version Valid from 15.05.2024
Main + corrigendum

EVS-EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
Valid from 08.12.2006
Main + amendment

EVS-EN 60601-1:2006+A1:2013+A12:2014

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
Valid from 02.03.2016

Customers who bought this item also bought

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
Main

EVS-EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Newest version Valid from 01.10.2021
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
Valid from 01.04.2021
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

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