Back

EVS-EN 60601-1-3:2008+A1+A11+A2:2021

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008 + IEC 60601-1-3:2008/A1:2013 + IEC 60601-1-3:2008/A2:2021)

General information
Valid from 01.04.2021
Base Documents
IEC 60601-1-3:2008; EN 60601-1-3:2008; EN 60601-1-3:2008/AC:2010; IEC 60601-1-3:2008/A1:2013; EN 60601-1-3:2008/A1:2013; EN 60601-1-3:2008/A1:2013/AC:2014; EN 60601-1-3:2008/A11:2016; IEC 60601-1-3:2008/A2:2021; EN 60601-1-3:2008/A2:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
01.04.2021
Main + amendment
01.04.2021
Amendment
06.12.2016
Amendment
05.06.2014
Corrigendum
05.08.2013
Amendment
08.04.2010
Corrigendum
09.06.2008
Main + corrigendum
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.
*
*
*
PDF
22.86 € incl tax
Paper
22.86 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main + amendment

EVS-EN 62366-1:2015+A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020)
Newest version Valid from 17.08.2020
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 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 IEC 60601-2-16:2019

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Newest version Valid from 03.06.2019