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BSI BS EN 60601-1-2:2015+A1:2021

Medical electrical equipment -- General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
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BSI BS EN 60601-1-2:2015+A1:2021

Medical electrical equipment -- General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests

PUBLISH DATE 2021
PAGES 116
BSI BS EN 60601-1-2:2015+A1:2021

This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems.

This collateral standard applies to the basic safety and essential performance of me equipment and me systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems.

Basic safety with regard to electromagnetic disturbances is applicable to all me equipment and me systems.

1.2 Object

The object of this collateral standard is to specify general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of me equipment and me systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards.

1.3 Related standards

1.3.1 IEC 60601‑1

For me equipment and me systems, this collateral standard complements IEC 60601‑1.

When referring to IEC 60601‑1 or to this collateral standard, either individually or in combination, the following conventions are used:

  • 'the general standard' designates IEC 60601‑1 alone, including any amendments;

  • 'this collateral standard' designates IEC 60601‑1‑2 alone, including any amendments; A1_end

  • 'this standard' designates the combination of the general standard and this collateral standard.

1.3.2 Particular standards

A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.

SDO BSI: British Standards Institution
Document Number EN 60601-1-2
Publication Date March 24, 2021
Language en - English
Page Count 116
Revision Level 1
Supercedes
Committee CH/62/1
Publish Date Document Id Type View
Oct. 31, 2015 BS EN 60601-1-2:2015 Revision
Sept. 28, 2007 BS EN 60601-1-2:2007 Revision
Oct. 31, 2006 BS EN 60601-1-2:2002 Revision
Aug. 15, 1993 BS EN 60601-1-2:1993 Revision
March 24, 2021 BS EN 60601-1-2:2015+A1:2021 Consolidated
July 31, 2010 BS EN 60601-1-2:2007 Consolidated