Savasto Catheter Bonding Machine is designed to comply with the safety requirements recommended by the laser manufacturer and by regulatory agencies such as CDRH, ANSI, and OSHA. According to the product classifications described below, Savasto Catheter Bonding Machine is a Class I laser system since it is a fully enclosed system and the laser beam is not accessible by the operator during normal operation. The laser unit used in Savasto Catheter Bonding Machine complies with the following regulations:
- 21CFR 1040.10 and 1040.11, CDRH (Center for Devices and Radiological Health).
- 47 CFR Part 18, FCC (Federal Communication Commission).
- EU Directive 89/336/EEC, EMC Directive
- EN60825-1, Laser Safety
- EN55011, Radiated, Class A, Group 2
- EN50082-1, Generic Immunity
- IEC801-2, Electrostatic discharge
- IEC801-3, RF Radiated
- IEC801-4, Fast Transients
