Acteon SATELEC - 10 Regulations and standards; 10.1 Applicable standards and regulations; 10.2 Medical class of the device; 10.3 Symbols

10 Regulations and standards
10.1 Applicable standards and regulations
This medical device complies with the essential requirements of European Directive 93/42/EEC. It was designed and
manufactured in accordance with an EN ISO 13485-certified quality assurance system.
This equipment is designed and developed in compliance with the Electrical Safety standard IEC60601-1 in force.
10.2 Medical class of the device
Class of medical device: IIa according to 93/42/EEC directive
10.3 Symbols
Symbol Meaning
Always wear safety goggles
Always wear protective gloves
Refer to the supporting documentation
Consult the User Manual
The accompanying documentation is available in electronic format
Pressure limit
Temperature limit
Humidity limit
Packaging unit
User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D - Page 21/28