Compliance
In February 2019, Part 5 of the DIN Standard 33961 came into play in Germany. It consists of regulations regarding the use of EMS studio equipment and for the operation of EMS facilities as well as the EMS-Training.
The new regulations provide legal certainty when using the EMS equipment and protect the operators from liability.
The main requirements stipulated in the DIN 33961 Part 5 are as follows:
Requirements for EMS-Training
- The user must be able to reach the operating device in 1 second (distance approximately 120 cm)
- The trainer must be able to reach the operating device in 1 second (distance approximately 120 cm)
- The trainer must be able to reach the user in 1 second (distance approximately 120 cm)
- A trainer must be present throughout every training session.
- The trainer and user must maintain constant eye contact and verbal communication.
- Every user must be given an initial briefing and complete an EMS-specific contraindications form in writing.
- Users must rest for at least four days between training sessions.
- Special requirements apply to the first training session and the first ten weeks of regular training.
- Each trainer must supervise no more than 2 users per training session.
Requirements for EMS Training Equipment
- All EMS training devices must comply with the DIN EN 61000 and DIN EN 60335 (CE declaration of conformity).
- Providers are obliged to use EMS training devices that have been developed and manufactured in accordance to the requirements set out in DIN EN 60601-2-10 (manufacturer’s certificate).
- A holding device (handle or handrail) for the user must be in place.
- The user must not be able to adjust the intensity of the device in rapid steps.
- All control elements that govern intensity must be recognisable and operable immediately and intuitively without switching menus.
- The trainer must be able to see clearly which user is connected to which device.
- All technical equipment must be authorised and approved by the manufacturer.
- Training clothes must have an antimicrobial coating or be machine-washable at 90 °C.
- Electrodes must have an antimicrobial coating or be cleaned and disinfected after every training session.
Requirements for Staff
- Every trainer must have at least a basic qualification in the field of individual fitness training (grade DQR 2 from a recognised or certified educational institute).
- Every trainer must also have an additional qualification in the field of EMS-Training from a certified educational institute and must have at least ten sessions’ worth of proven training experience.