19 October 2020 | Cranage EMC & Safety Ltd

Cranage EMC and Safety- Medical Device Testing

Medical devices are, understandably, tightly regulated due to the potentially fatal impact of an EMC or safety failure.

The term ‘medical device’ covers a huge range of items, from simple digital thermometers to highly sophisticated implanted devices intended to sustain life.

Within the EU, medical devices must comply with the Medical Device Regulations 2017/745 (MDR). This recently introduced legislation replaces the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMD). Although manufacturers have until 26th May 2021 to comply, it is recommended there is not complacency around the changes that are made.

Medical devices are classified by their risk, and in Europe this is as follows•

Class I- low risk items, such as wheelchairs
Class IIa- usually low to medium risk and not used for long periods of time, for example tracheotomy tubes
Class IIb- medium to high risk and may be used for longer than 30 days, such as ventilators
Class III- these are the highest risk, an example being pacemakers.

All medical devices, with the exception of most in Class I, must be assessed by a Notified Body. Manufacturers must produce a Technical File, which includes details on the design and manufacture of the item, before they can consider a CE mark.

Medical devices must be tested for the relevant product safety and EMC standards to ensure they are safe to use. The most common standards are IEC/EN 60601-1 and IEC/EN 60601-1-2, covering the basic safety and essential performance of medical electrical equipment.

Cranage EMC and Safety is a UKAS accredited test laboratory for these standards and our team of experienced engineers can test a vast range of medical devices, with our previous tests including hospital beds, prosthetic limbs, blood pressure monitors, ultrasound devices and pulse oximetry.

Our UKAS accreditation shows we are regularly assessed for our technical competence, something which is particularly important for this field of testing. We have been UKAS accredited for 15 years, giving our customers assurance of our competence and impartiality.

Get in touch with our team to discuss how we can help you with your medical device testing.

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