Modification 2 a la Publication 601-2-1 (1981) Safety of Medical Electrical Equipment Part 2: Particular Requirements for Medical Electron Accelerators in the Range 1 MeV to 50 MeV Section One: General Section Two: Radiation Safety for Equipment
|Publication Date:||1 February 1990|
The test procedures described in this amendment are classified in three grades:
Inspection of the analysis of equipment design provided by the manufacturer as related to the specified safety provisions.
Visual inspection, functional test or measurement on the equipment. The test procedures are specified by this amendment to the Particular Standard. The test procedures are based only on operating states (including fault condition states) achievable without interference with the circuitry or construction of the equipment.
Functional test or measurement on the equipment. The test procedure shall be specified by the manufacturer in the ACCOMPANYING DOCUMENTS in accordance with the principle stated in this amendment to the Particular Standard. The test procedure may involve operating states which require interference with the circuity or construction of the equipment. In such cases of interference, the work should be personnel or under the direct supervision or approval of the manufacture's personnel.
Test procedures specified by the manufacturer shall include instructions on how to reset the equipment into the primary condition after the execution of the tests, and how this condition shall be verified.
Test Procedures specified by the manufacturer shall include the test condition (e.g. GANTRY angular Position, NOMINAL ENERGY, RADIATION TYPE).
Test procedures specified by the manufactures shall either:
a) Generate the described fault condition or, if not practicable
b) As near as practicable to the source of the signal that would be produced in a fault condition, simulate this signal.
The manufacture shall demonstrate in the ACCOMPANYING DOCUMENTS by results of design analysis or experiment that the test signal accurately simulates the signal that would be produced in the fault condition.
Note. - In special cases, one test signal may simulate more than one fault condition.