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About This Item

 

Full Description

This is the second edition of CAN/CSA-C22.2 No. 60601-2-47. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14. This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS.

Within the scope of this standard are systems of the following types:

a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard;
b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

The safety aspects of this standard apply to all types of systems falling in one of the abovementioned categories.

 

Document History

  1. CAN/CSA C22.2 NO. 60601-2-47:14 (R2018)

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    Medical Electrical Equipment - Part 2-47: Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic Systems (Adopted IEC 60601-2-47:2012, second edition, 2012-02, with Canadian deviations)

    • Most Recent
  2. CAN/CSA C22.2 NO. 60601-2-47-03 (R2012)


    Medical Electrical Equipment - Part 2-47: Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic Systems (adopted CEI/IEC 60601-2-47:2006, first edition, 2001-07)

    • Historical Version