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SSH EN 60601-1-4:1996

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

Jul 5, 2004

General information

60.60     Jul 5, 2004

DPS

DPS/KT 316

European Norm

11.040  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

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Life cycle

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PUBLISHED
SSH EN 60601-1-4:1996
60.60 Standard published
Jul 5, 2004

Related project

Adopted from EN 60601-1-4:1996

Adopted from IEC 60601-1-4 Ed. 1.0 b

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