IEC 60601-1-12: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

In September, we successfully extended our scope under the IECEE CB scheme for collateral standard IEC 60601-1-12: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.

This collateral standard is applicable to products used for emergencies outside of professional healthcare facilities where a patient can be given medical care, and basic or advanced life support as well as during professional transport to a professional healthcare facility or between professional healthcare facilities.

Three different types of equipment and usage are covered by the standard:
a) Fixed or permanently installed ambulance equipment and mounting accessories
b) Transportable ME equipment
c) Airborne ME equipment and mounting accessories

There are additional requirements in relation to the general medical standard based on the equipment type and usage.

For EMC, there is an additional requirement in case equipment is intended for aircraft (Equipment shall additionally comply with EUROCAE ED-14G or RTCA DO-160G).

More information:
Janez Vidmar
E-mail: janez.vidmar@siq.si
Tel.: +386 1 4778 178