Safety checks and electrical safety testing of medical devices

What this covers

The focus is on devices that apply energy to people. That is precisely where the permitted leakage currents are lowest, and precisely those devices that many testing services leave alone. We regularly test:

Light and lasers

• Diode lasers for hair removal, in all common wavelengths
• Alexandrite and Nd:YAG lasers
• Er:YAG and CO2 lasers for ablative treatments
• IPL and flash lamp systems
• LED and light therapy devices

Radio frequency, ultrasound and cold

• High frequency and radio frequency devices
• Focused ultrasound (HIFU)
• Ultrasound and cavitation devices
• Cryolipolysis devices

Current and mechanics applied to people

• EMS and muscle stimulation devices
• Electrotherapy and stimulation current devices
• Microneedling and RF needling devices
• Plasma pens
• Microdermabrasion and suction devices

To that comes whatever stands in the same rooms and has to be tested alongside: motorised treatment couches, extraction systems, sterilisers, autoclaves, compressors and the ordinary equipment.

Whether an individual device is to be treated as a medical device or as electrical work equipment is determined by the manufacturer intended purpose. The test procedure follows from that, and so do the limit values. We record this during the survey and classify every device traceably before anything is measured.

What we do not do: metrological checks

The metrological check under Section 14 MPBetreibV is expressly not part of what we offer. It is a separate procedure with its own requirements and concerns the devices in Annex 2 of the operator ordinance, among others:

• non-invasive blood pressure monitors
• eye tonometers
• therapy and diagnostic dosimeters
• bicycle ergometers
• devices for determining hearing thresholds

If such devices are in your stock, we tell you so at the survey and name them in the schedule of due dates. You will need to have them checked by a different body. The electrical safety of these devices we do cover; that falls under the recurring test.

What gets tested

The electrical safety test to DIN EN 62353 differs from testing ordinary equipment above all in its limit values: on devices with applied parts in contact with the patient, permitted leakage currents are set considerably lower.

• Inspecting: housing, applied parts, leads, labelling, accessories, installation conditions.
• Measuring: protective conductor resistance, equipment leakage current, patient leakage current, insulation resistance. Where required, the substitute leakage current method.
• Functional testing: controls, alarms, safety cut-outs.
• Recording reference values: the measured values from the first test serve as the basis for comparison for all that follow.

For Annex 1 devices the safety check is added. Its scope is set out in the instructions for use and differs from device to device. We work through it and document it exactly as the manufacturer specifies.

Who it is for

Beauty and cosmetic studios with laser, IPL and RF technology, dermatological and aesthetic practices, physiotherapy, podiatry, occupational therapy, plus medical and dental practices with energy-applying devices. Everywhere energy is applied to people and the limit values are therefore tighter than for a kettle.

The practical advantage

In many practices two separate schedules run side by side: one for the medical devices, one for the rest of the electrical equipment. We bring the two together. One appointment, one contact, one overview showing when each device is next due.