Testing Intervals for Medical and Cosmetic Devices: The Complete Overview
All device types, legal bases, testing types, and intervals at a glance
Why a testing intervals overview?
Operators of cosmetic studios, medical practices, care facilities, and clinics face the challenge of complying with various testing obligations from different legal bases. Depending on the device type, the MPBetreibV, DGUV Vorschrift 3, the NiSV, and the Occupational Health and Safety Act may apply simultaneously — with different intervals, testing types, and tester qualifications.
This overview brings order to the topic and shows for each device type which tests are due and when.
The comprehensive testing intervals table
Medical devices — Annex 1 MPBetreibV (STK-mandatory)
| Device type | Test type(s) | Legal basis | Interval | Tester qualification |
|---|---|---|---|---|
| Defibrillator (AED, manual) | STK + DGUV V3 | §12 MPBetreibV, DGUV V3 | STK: 2 years, DGUV: 12 mo. | §5 MPBetreibV + qualified electrician |
| Infusion pump / syringe pump | STK + MTK + DGUV V3 | §12, §15 MPBetreibV, DGUV V3 | STK: 2 years, MTK: 2 years, DGUV: 12 mo. | §5 MPBetreibV |
| HF surgery device | STK + DGUV V3 | §12 MPBetreibV, DGUV V3 | STK: 2 years, DGUV: 12 mo. | §5 MPBetreibV |
| Ventilator (CPAP, BiPAP) | STK + DGUV V3 | §12 MPBetreibV, DGUV V3 | STK: 2 years, DGUV: 12 mo. | §5 MPBetreibV |
| Infant incubator | STK + DGUV V3 | §12 MPBetreibV, DGUV V3 | STK: 2 years, DGUV: 12 mo. | §5 MPBetreibV |
| Medical laser (class 3B/4) | STK + DGUV V3 | §12 MPBetreibV, DGUV V3 | STK: 2 years, DGUV: 12 mo. | §5 MPBetreibV |
Medical devices — other (not Annex 1)
| Device type | Test type(s) | Legal basis | Interval | Tester qualification |
|---|---|---|---|---|
| ECG device | DIN EN 62353 | DGUV V3, MPBetreibV §7 | 12–24 months | §5 MPBetreibV / qualified electrician |
| Ultrasound device (diagnostic) | DIN EN 62353 | DGUV V3, MPBetreibV §7 | 12–24 months | §5 MPBetreibV / qualified electrician |
| Hospital bed (electrically adjustable) | DIN EN 62353 | DGUV V3, MPBetreibV §7 | 12–24 months | §5 MPBetreibV / qualified electrician |
| Patient lift | DIN EN 62353 | DGUV V3, MPBetreibV §7 | 12–24 months | §5 MPBetreibV / qualified electrician |
| Blood pressure monitor (electric) | DIN EN 62353 + MTK | DGUV V3, §15 MPBetreibV | 24 months | §5 MPBetreibV |
| Sterilizer / autoclave | DIN EN 62353 | DGUV V3, MPBetreibV §7 | 12–24 months | §5 MPBetreibV / qualified electrician |
Annex XVI products (MDR) — Cosmetic devices with medical device status
| Device type | Test type(s) | Legal basis | Interval | Tester qualification |
|---|---|---|---|---|
| IPL device (cosmetic) | DGUV V3 + NiSV §3 | DGUV V3, NiSV, MDR Annex XVI | 12 months + daily | Qualified electrician / §5 MPBetreibV |
| Cosmetic laser (diode, Nd:YAG etc.) | DGUV V3 + NiSV §3 | DGUV V3, NiSV, MDR Annex XVI | 12 months + daily | Qualified electrician / §5 MPBetreibV |
| HIFU device | DGUV V3 + NiSV §3 | DGUV V3, NiSV, MDR Annex XVI | 12 months + daily | Qualified electrician / §5 MPBetreibV |
Note: The exact testing requirements under MDR Annex XVI are still partially being implemented. More on this in our article MDR Annex XVI explained.
Pure cosmetic devices (not a medical device)
| Device type | Test type(s) | Legal basis | Interval | Tester qualification |
|---|---|---|---|---|
| Facial steamer / vapozone | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 12–24 months | Qualified electrician |
| UV nail lamp | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 12–24 months | Qualified electrician |
| Wax heater / paraffin bath | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 12–24 months | Qualified electrician |
| Microdermabrasion | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 12–24 months | Qualified electrician |
| LED light therapy | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 12–24 months | Qualified electrician |
| RF / high-frequency device (cosmetic) | DIN VDE 0701-0702 + NiSV §3 | DGUV V3, NiSV | 12 months + daily | Qualified electrician |
| EMS device (cosmetic) | DIN VDE 0701-0702 + NiSV §3 | DGUV V3, NiSV | 12 months + daily | Qualified electrician |
General electrical devices
| Device type | Test type | Legal basis | Interval | Tester qualification |
|---|---|---|---|---|
| Power strips, extension cords | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 12 months | Qualified electrician |
| Computer, printer, monitor | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 24 months | Qualified electrician |
| Hair dryer, air conditioner (mobile) | DIN VDE 0701-0702 | DGUV V3, BetrSichV | 12–24 months | Qualified electrician |
| Fixed electrical installations | DIN VDE 0105-100 | DGUV V3, BetrSichV | 48 months | Qualified electrician |
What happens when testing intervals are exceeded?
The consequences of exceeding an interval vary in severity depending on the device type and legal basis:
Liability
In the event of damage caused by a device that was not tested on time, the operator is personally liable. The burden of proof is reversed: the operator must demonstrate that the damage would have occurred even with proper testing. In practice, this is virtually impossible to prove.
Insurance coverage
Business liability and professional liability insurance may reduce or deny benefits if the damage was caused by an untested device. The statutory accident insurance (Berufsgenossenschaft) can also seek recourse against the operator.
Fines
- ✓ DGUV V3: Fines up to 10,000 EUR from the professional association
- ✓ MPBetreibV: Fines for violations of §12 (STK) or §15 (MTK)
- ✓ NiSV: Fines up to 50,000 EUR per violation
- ✓ BetrSichV: Fines up to 25,000 EUR for violations of testing obligations
Prohibition of operation
For STK-mandatory medical devices (Annex 1), the device may no longer be used after the deadline expires until the STK has been completed. Under DGUV V3, the professional association or trade supervisory authority can prohibit use.
Tip: The risk assessment determines the intervals
The intervals listed in the tables are guideline values and maximum intervals. The specific testing intervals for your operation result from the risk assessment per §3 BetrSichV. The following factors play a role:
- ✓ Frequency of use: Devices used daily are subject to greater stress
- ✓ Environmental conditions: Humidity, dust, temperature
- ✓ Type of use: Devices with skin contact carry a higher risk
- ✓ Manufacturer specifications: Always take precedence over general guideline values
- ✓ Previous test results: Frequent defects may justify shorter intervals
- ✓ Age of the device: Older devices may require shorter intervals
Interval management made easy
Do you have many devices with different testing intervals? Elektrotechnik Driller offers a device management service: We record all your devices, manage the testing intervals, and remind you in time of the next appointment. So you never miss a deadline.
Special case: Testing after repair or maintenance
Regardless of regular testing intervals: After every repair, maintenance, or modification of a device, a new test must be performed before recommissioning. This applies to:
- ✓ Medical devices: §7 MPBetreibV — testing after maintenance
- ✓ General devices: DIN EN 50678 (formerly DIN VDE 0701) — testing after repair
- ✓ Replacement of wear parts (e.g. IPL lamp) also counts as maintenance
Have your testing intervals checked now
Unsure which intervals apply to your devices? We are happy to advise you and take over interval management: