This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO
DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT. This part of IEC 61326 applies to the BASIC SAFETY
and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to
electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
Note 1: performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
Note 2: IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE
Registration number (WIID)
79626
Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO
DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT. This part of IEC 61326 applies to the BASIC SAFETY
and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to
electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
Note 1: performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
Note 2: IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE
