Need help?

EN 60601-1-4:1996 Standard

wave
Save  

  Keywords:

#iec #edition #energized #devices #second

This standard is superseded by:
  •   EN 60601-1-4:1996/A1:1999
  • This standard can be totally or partially supervised by:
  •   EN 60601-1-4:1996/A1:1999
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systemsIEC 60601-1-4:1996

      Purpose

    IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: - alignment of requirements with IEC 60601-1:2005; - inclusion of essential performance requirements; - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN ISO 81060-1:2012

    Medical devices Directive (93/42/EEC)

    Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

    EN ISO 10993-17:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

    EN ISO 13408-7:2015

    Medical devices Directive (93/42/EEC)

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

    EN 13060:2014

    Medical devices Directive (93/42/EEC)

    Small steam sterilizers

    EN ISO 11810-2:2009

    Medical devices Directive (93/42/EEC)

    Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-pro...

    EN ISO 11810-1:2009

    Medical devices Directive (93/42/EEC)

    Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient pro...

      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 60601-1-4:1996 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