Need help?

EN 60601-1-3:2008/AC:2010 Standard

wave
Save  

  Keywords:

#equipment #medical #systems #electrical #applies

This standard is superseded by:
  •   EN 60601-1-3:2008/A11:2016
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipmentIEC 60601-1-3:2008

      Purpose

    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 the PATIENT are used for diagnosis, planning or guidance of medical procedures.

      Publication

    Friday 17th of November 2017

      Correction

    This standard is a correction for "EN 60601-1-3:2008"

      Related Standards

    EN 61676:2002/A1:2009

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiol...

    EN 60627:2001

    Medical devices Directive (93/42/EEC)

    Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter gridsIEC 60627:2001

    EN IEC 60601-2-83:2020

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light the...

    EN ISO 80601-2-55:2018

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory ga...

    EN 62220-1-2:2007

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum...

    EN 62220-1:2004

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum e...

      Stay up to date

    CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

    CELAB performs voluntary inspection activities on technical construction files to check their contents.

    CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

    CLICK HERE TO GET TESTS AND INFO ON THE EN 60601-1-3:2008/AC:2010 STANDARD

      ACCESS

    Search for a standard
    GO

    Register

    Already a member?
    Login

      OTHER APPLICATIONS

    If you are interested in DO160 tests, you can give a try to our other free of charge software:
    CE-Marking assistant, Version: 1.3.0