SGS Expanding its Testing Spectrum for Medical Devices According to AIM 7351731
RFID systems can disrupt medical equipment and trigger dangerous incidents. To prevent this, protected electromagnetic compatibility (EMC) is indispensable. Now, SGS is going to provide this testing services in the field of RFID to manufacturers of medical devices.
Increasing numbers of RFID systems are being used, not just in the field of medical equipment. RFID stands for Radio Frequency Identification. Its use makes the contact-free reading and storage of patient data possible, for example. The problem: RFID systems can disrupt medical equipment – for example, by stopping infusion pumps or dialysis equipment. To rule out such risks in advance, medical equipment must have a high degree of electromagnetic compatibility (EMC) and be absolutely interference-proof. The testing and verification company SGS tests this at its Munich location according to the AIM standard 7351731.
Additional Tests apart from IEC 60601-1-2
The additional international IEC 60601-1-2:2014 standard admittedly specifies what must be borne in mind to ensure electromagnetic medical equipment is secure. However, there is a lack of definitions of specific test procedures and test levels regarding RFID. The AIM 7351731 standard fills precisely this gap. Consequently, the US FDA (Food and Drug Administration) recognized it several years ago. It requires the test according to the AIM standard in addition to qualification according to IEC 60601-1-2 to demonstrate that RFID systems cannot negatively affect medical equipment.
On this basis, medical equipment is exposed to radiation in the frequencies 433 Megahertz (MHz), 860 to 960 MHz and 2.45 Gigahertz (GHz) with field strengths of up to 54 Volt per metre (V/m) in the EMC laboratory of SGS. Tests occur with special Helmholtz coils and magnetic field up to 65 amperes per metre (A/m) in the additional RFID sequences 134.2 Kilohertz (kHz) and 13.56 MHz. Manufacturers can rely on the result: the expert procedures of SGS have been certified by the German Accreditation Body (Deutsche Akkreditierungsstelle, DAkkS).