Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
|Publication Date:||1 September 2020|
|ICS Code (Immunity):||33.100.20|
|ICS Code (Emission):||33.100.10|
|ICS Code (Medical equipment in general):||11.040.01|
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.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.