EVS-EN 60601-1-2:2015+A1:2021

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + IEC 60601-1-2:2014/A1:2020)

General information
Valid from 01.04.2021
Base Documents
EN 60601-1-2:2015; IEC 60601-1-2:2014; EN 60601-1-2:2015/A1:2021; IEC 60601-1-2:2014/A1:2020
Directives or regulations

Standard history

Main + amendment
EN 60601-1-2 (IEC 60601-1-2) applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems (ME equipment and ME systems).

Medical electrical equipemnt and medical electrical systems are expected to provide their basic safety and essential performance without interfering with other equipment and systems in the electromagnetic environments in which they are intended by their manufacturer to be used.

EN 60601-1-2 applies to basic safety and essential performance with regard to electromagnetic disturbances of ME equipment and ME systems. Applicability of this collateral standard includes ME equipment and ME systems that have been found to have no essential performance.

Since the publication of IEC 60601-1-2:2014, the IEC subcommittee has been collecting issues from a variety of sources including comments from national committees. The high priority issues that need to be considered in an amendment and should not wait until the next edition can be found in this consolidated version.

The main text and the consolidated version which consists of main text and the amendment can be found from the standard’s history.

The text of IEC 60601-1-2:2014 has been approved in Europe as EN 60601-1-2:2015 without any modification and it supersedes EN 60601-1-2:2007.
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