IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission.
IEC 60601-1-2: 2007 and IEC 60601-1-2: 2014 are the standards relating to Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
EMC Bayswater is NATA accredited to the EMC Safety standard IEC 60601-1-2.
EMC Bayswater is also NATA accredited to IEC 61326-1 and IEC 61326-2-6 and EN 61326-2-6.
Croydon South EMC testing for medical devices can be more complicated than other products with respect to documentation and manufacturer’s input such as providing Risk assessments for deviations in performance. Examples of Risk assessment could be an ESD discharge causing an infusion pump to administer drugs at a higher rate than programmed by the medical practitioner, this would be an unacceptable risk to the patient, whilst if it only caused a momentary flicker on a LED indicator this may be deemed an acceptable patient risk.
Testing medical devices for Australia
The ACMA’s Electromagnetic Compatibility (EMC) regulatory arrangement imposes an obligation on suppliers (i.e. importers, manufacturers and agents) to ensure that the relevant emissions standards are complied with prior to market delivery. Not all medical devices are subject to the ACMA regulatory arrangement directly as they maybe regulated by the Therapeutic Goods Administration (TGA). The TGA specifies performance and safety characteristics for these devices; this includes EMC testing of the devices. Medical devices regulated by the TGA are exempt from the ACMA’s EMC requirements because they are required to meet the TGA’s EMC requirements, however other testing maybe required, an example would be medical devices incorporating other technologies such as telecommunications products and radio communications transmitters.
Testing medical devices for the CE mark
As per all CE mark testing there is a standards framework in place that is used for the compliance of medical devices. The official journal of the European Union (OJEU) lists the harmonised standards for medical devices can be found here, in addition comprehensive medical device guidelines can be found online.