No. | Test Item | Test Standards | Test Method |
1 | Marking | 1. General Matter The marking of laser equipment must comply with IEC 825-1, Clauses 5.5, 5.6, 5.8, 5.9, 5.10 and 5.11. 2. Outlet Marking Laser equipment must attach outlet labels on each laser outlet. (exclusive of hand piece) | IEC 60601-2-22:1995 Clause 6 |
2 | Laser Beam | Laser equipment must comply with the following requirements for the protection of patients, operators and other people in the surrounding. 1. Remote Interlock Connector (IEC 825-1 Clause 4.4) 2. Key Controlled (IEC 825-1 Clause 4.5) 3. Optical Device for Observing (Clause IEC 825-1 Clause 4.9) 4. Laser Emission Ready Indicator 5. Laser Outlet Warning Device 6. Target Indicator Device | IEC 60601-2-22:1995 Clause 32 |
3 | Stoppage of Power Supply | Class 4 laser products must be equipped with the manual reset function that can restart the emission of the laser radiation after the interruption of emission due to the use of remote interlock and the interruption of emission for longer than 1 second due to unforeseen power outage. | IEC 60601-2-22:1995 Clause 49.2 |
4 | Accuracy of Output Data | 1. Laser equipment for irradiating human body must be able to display a means for presetting the output of radiated beam. 2. Such display should be expressed in SI units. 3. The actual output value of the measured laser beam must not be ±20%. | IEC 60601-2-22:1995 Clause 50.2 |
5 | Emergency Laser Stop Device | Emergency Laser Stop Device must interrupt the emission of laser output as quickly as possible in order to prevent any harm upon human. Emergency laser Stop Device must be designed independently. The switch must be red and push button type, and must be clearly visible and positioned so that it is quickly and easily reached by the operator during operation. Chart DI, symbol 101, ‘Laser Stop’ or such symbols must be indicated either on the push button switch or near the push button switch. | IEC 60601-2-22:1995 Clause 51.101 |
6 | Cord Attached Tree Branch Type Controller & Pedal Controller | 1. Mechanical Intensity: Pedal switch must satisfy the following requirements. – Foot-operated, exposed control switch must be covered to prevent unintended operation. The strength necessary for operating the switch must be above 10N but below 50N from any location of the pedal surface that is 625mm2 in area. | IEC 60601-2-22:1995 Clause 56.11 |
7 | Stand-by / Ready Device | Laser equipment must have the ‘Stand-by and Ready’ Device. This device must be equipped with the function for interrupting radiation beam. | IEC 60601-2-22:1995 Clause 56.101 |
