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EN 60601-1-4:1996

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

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Dec 31, 2018

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040   Medical equipment

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Scope

Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk.This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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Life cycle

NOW

WITHDRAWN
EN 60601-1-4:1996
99.60 Withdrawal effective
Dec 31, 2018

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 60601-1-4:1996/A1:1999

REVISED BY

PUBLISHED
EN 60601-1:2006