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About This Item

 

Full Description

The objective of this Standard is to establish particular basic safety and essential performance requirements for cardiac defibrillators. This Standard does not apply to implantable defibrillators, remote control defibrillators, external transcutaneous pacemakers, or separate stand-alone cardiac monitors (which are standardized by AS/NZS IEC 60601.2.27:2016). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this Standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion.
 

Document History

  1. AS 60601.2.4:2018

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    Medical electrical equipment, Part 2.4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010 (ED. 3.0), MOD)

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  2. AS/NZS 3200.2.4:2006


    Medical electrical equipment, Part 2.4: Particular requirements for safety - Cardiac defibrillators

    • Historical Version
  3. AS/NZS 3200.2.4:1993


    Medical electrical equipment - Approval and test specification, Part 2.4: Particular requirement for safety - Cardiac defibrillators and cardiac defibrillator-monitors

    • Historical Version
  4. AS 3204-1981


    Approval and test specification for cardiac defibrillators

    • Historical Version
  5. AS 3201.4-1973


    Approval and test specification, Part 4: D.C. cardiac defibrillators

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. AS 60601.2.4:2018 Amd 1:2022

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    Medical electrical equipment, Part 2.4: Particular requirements for the basic safety and essential performance of cardiac defibrillators