SGS Helps Emergency Medical Equipment Manufacturers Understand IEC 60601-1-12

GENEVA - Aug. 14, 2019 - PRLog -- Released in 2014, IEC 60601-1-12 has been adopted for the IECEE CB Scheme, an international system for mutual acceptance of test reports and certificates dealing with safety in electrical and electronic components, equipment and products. It has also been included on the US Food and Drug Administration's (FDA) "List of Recognized Consensus Standards", and is also expected to be implemented by the European Commission, probably when it transitions to the new Medical Devices Directive (MDR) in 2020.

IEC 60601-1-12 matches the requirements in EN 1789 and EN 13718-1. It amalgamates the requirements from different applications into a single standard. Manufacturers of a wide variety of medical devices can therefore look on IEC 60601-1-12 as the decisive standard for active medical equipment used in and around ambulances and at locations where emergency medical services are needed, e.g. accident or crash sites.

The key constructional requirements are:

·         Equipment is classified as Class II, meaning protection must not rely upon an earth or the equipment should use an internal battery power supply

·         Must be able to withstand an AC Mains voltage supply tolerance from 85% to 110% of nominal voltage range

·         Equipment intended to be supplied by DC voltage (e.g. by car battery) must maintain its function under the following circumstances:

o   30 s dip from 12V to 10V for 12Vdc rating and fluctuations between 12.4 V to 15.1 V

o   30 s dip from 24V to 20V for 24Vdc rating and fluctuations between 24.8 V to 30.3 V

·         Medical equipment intended for operation in aircraft must be capable working with following supplies:

o   14, 28, and 270 Vdc; and

o   115/230 V at 400 Hz

·         Must operate for a minimum of 20 minutes in the following environmental conditions:

o   Temperature range of -20 to + 50 °C

o   Atmospheric pressure range of 620 hPa to 1060 hPa

o   Relative humidity of between 15 and 90%

The standard also requires that the instructions for setting up and controlling the unit, and analyzing the results, must be readily accessible and visible between an illuminance level from 10 to 10,000 lx – twilight to full daylight.

With IEC 60601-1-12 gaining acceptance with authorities around the world, SGS is advising manufacturers of emergency medical equipment to now check their products comply with its requirements.

SGS offers a cost-effective testing and certification service to help these manufacturers efficiently bring their emergency medical equipment products to the marketplace.

For more information, please contact:

Andreas Michel

Tel: +49 89 787475 425

Email: crs.media@sgs.com

Website: www.sgs.com/ee