EMC Testing for Medical Devices

Testing of medical devices requires a more rigorous approach than other products due to the type of environment their placed into. High risk electrical and electronic medical devices can be affected by electromagnetic interference (EMI) which can lead to potential malfunctioning causing inconvenience, and even life threating situations.

RN Electronics offer a comprehensive and well equipped testing service to perform such tests, contact us to discuss the applicable EMC test standards and for advice on the requirements for EMC testing of medical devices.

Medical Testing Capabilities

Radiated Emissions
10kHz-170GHz

Radiated Immunity
10kHz-18GHz

Conducted Emissions
30Hz-100MHz

Conducted Immunity
30Hz-400MHz

Magnetic Emissions
30Hz-100kHz

Magnetic Immunity
DC & 16Hz-100kHz

ESD 0.2kV-16.5kV

Surges 0.2kV-4.4kV (1.2/50µs)

Fast Transients
(EFT/B) 0.2kV-4.4kV

Voltage Dips & Interruptions

Harmonics <16A

Flicker <16A

Medical Equipment Testing Standards

We can test to all of the following standards and many others:

EN 60601-1-2
Medical electrical equipment

EN 61326-2-6
In vitro diagnostic medical equipment

EMC Testing of Medical Devices intended for Europe

CE marking is a legal requirement for medical devices intended for sale in Europe, the directives that specifically apply to medical devices manufacturers are:

- The EMC Directive 2014/30/EU / Electromagnetic Compatibility Regulations - sets the requirements for the control of emissions and immunity standards for all electrical and electronic products.

- The Medical Device Regulation (MDR) 2017/745 - applies to all general Medical Devices and Active Implantable Medical Devices not covered by the Vitro Diagnostics Regulation. The MDR supports the evolving technological and scientific progress requirements for medical devices.

- The In Vitro Diagnostics Regulation (IVDR) 2017/746 - is the Regulation for placing on the market, making available and putting into service of in vitro diagnostic medical devices on the European market.

Replacing the previous directives, the Medical Device, Active Implantable and In-Vitro Diagnostic Directives (MDD (93/42/ECC), AIMDD (90/385/EEC), and IVDD (98/79/EC) in a complete overhaul of the legal regulations for medical devices.

MDR
Manufactures of medical devices should check the requirements of the MDR and have a through understanding of the legislation, consulting the reclassification of certain product groups as well as the legislations wider definition of medical devices. More guidance for manufactures can be viewed here.

Timeline

EMC Testing of Medical Devices intended for the UK

RN Electronics are UKAS accredited to the 4th edition of the EMC standard for medical electrical equipment, EN 60601-1-2.

The 4th edition of the standard defines tests and limits according to risk, medical devices are expected to perform according to their intended use and remain safe (essential performance and safety). For example, equipment intended to be used in a professional healthcare facility may have different requirements from that used in a home healthcare environment.

We have many years’ experience of accredited EMC testing of medical electrical equipment to EN 60601-1-2 and can work with manufacturers who are planning to adopt new and wireless technologies.

EU directives are given effect in UK law through The Medical Devices Regulations 2002 (SI 2002 No 618, as amended).

Under the UK MDR and in line with the MHRA guidance, medical devices placed on the market in the UK must be registered with the MHRA. If a manufacturer does not have a registered place of business in the UK, the UK Responsible Person will be responsible for registering the device with the MHRA.

EMC Testing of Medical Devices to meet FDA

In the United States, medical devices must meet Food and Drug Administration (FDA) standards. IEC 60601-1-2 fourth edition has significant changes that impact both testing and risk management related to basic safety and essential performance. On December 31st, 2018, this standard became mandatory for new product submittals to the U.S. Food and Drug Administration.

Guidance on medical electrical equipment can be viewed here.