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AS/NZS 3200.1.4:1997

AS/NZS 3200.1.4:1997

$37.70

Approval and test specification – Medical electrical equipment – General requirements for safety – Collateral Standard: Programmable electrical medical systems

Published By Publication Date Number of Pages
AS 1997-07-05 35
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Specifies requirements for the process by which a programmable electrical medical system is designed. This Standard is supplementary to AS 3200.1.0-1990, and is identical with and reproduced from IEC 60601-1-4:1996.

Scope

This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).

NOTE – Some systems which incorporate software and are used for medical purposes fall outside the scope of this Collateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not the system satisfies the definition of MEDICA L ELECTRIC AL EQUIPMENT in 2.2.15 of IEC 601-1 or the definition of MEDICA L ELECTRIC AL SYSTEM In 2.203 of IEC 601-1-1.

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AS/NZS 3200.1.4:1997
$37.70