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AS/NZS IEC 60601.2.25:2016

Current
Current

The latest, up-to-date edition.

Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographs
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

06-02-2016

Preview

Adopts IEC60601-2-25, Ed. 2.0 (2011), which applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes.

This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of anME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred toas ME EQUIPMENT.Not included within the scope of this particular standard are:a) the part of ME EQUIPMENT that provides vectorcardiographic loops;b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where notintended for obtaining ECG REPORTS for diagnostic purposes;c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECGREPORTS for diagnostic purposes.NOTE 1 For example. ME EQUIPMENT includes:a) direct-writing ELECTROCARDIOGRAPHS;b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercisetesting devices;c) ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines, networks or storage media).These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media.NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function.ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use.

Committee
HE-003
DocumentType
Standard
ISBN
978 1 76035 502 9
Pages
89
PublisherName
Standards Australia
Status
Current
Supersedes

Standards Relationship
IEC 60601-2-25:2011 Identical

Originated in Australia as AS 3201.3—1971.Previous and first New Zealand edition AS/NZS 3200.2.25:1993.Jointly revised and redesignated as AS/NZS IEC 60601.2.25:2016. Originated in Australia as AS 3201.3-1971. Previous and first New Zealand edition AS/NZS 3200.2.25:1993. Jointly revised and redesignated as AS/NZS IEC 60601.2.25:2016.

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