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SRPS EN 60601-1-2:2009

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Oct 28, 2009
95.99 Withdrawal of Standard   Aug 27, 2012

General information

95.99     Aug 27, 2012

ISS

N062

European Norm

33.100.10     11.040.01     33.100.20  

English  

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Scope

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005.

Related directives

Directives related to this standard.

93/42/EEC

Medical devices

Harmonized
2004/108/EC

Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC

2014/30/EU

Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)

Life cycle

NOW

WITHDRAWN
SRPS EN 60601-1-2:2009
95.99 Withdrawal of Standard
Aug 27, 2012

REVISED BY

WITHDRAWN
SRPS EN 60601-1-2:2012

Related project

Adopted from EN 60601-1-2:2007

Regulation

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