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SRPS EN 60601-1-4:2010

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

Dec 30, 2009
Dec 30, 2009
95.99   Withdrawal of Standard   Aug 27, 2012

General information

95.99     Aug 27, 2012

ISS

N062

European Norm

11.040     11.040.01  

Serbian  

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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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS IEC 60601-1-4:1999

NOW

WITHDRAWN
SRPS EN 60601-1-4:2010
95.99 Withdrawal of Standard
Aug 27, 2012

Related project

Adopted from EN 60601-1-4:1996/A1:1999

Adopted from EN 60601-1-4:1996

National regulations and standards

"Сл. гласник РС" бр. 92/2020 Правилник о боверавању мерних уређаја који су саставни део неонаталних и педијатријских инкубатора и реанимационих топлих столова