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Ul 60601-1 Medical Electrical Equipment General Requirements

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Example text

Sparks may be caused where electrical circuits are opened or closed by operation of switches, connectors, fuses or OVER-CURRENT RELEASES and the like. In HIGH VOLTAGE parts sparks may be caused by corona. Static discharges may cause sparks. The probability of ignition of such anaesthetic mixtures depends on their concentration, the appropriate minimum ignition energy, the presence of high surface temperatures and the energy of sparking. The hazard caused by an ignition depends on the location and on the relative quantity of the mixture.

If contact is incidental to the functioning of the EQUIPMENT, the part is categorized according to whether contact results from deliberate action by the PATIENT or by the OPERATOR. Where contact is incidental and results from action by the PATIENT, the PATIENT is in most respects no more at risk than any other person, so the requirements for ENCLOSURES are sufficient. In order to assess which parts are APPLIED process is employed in the order shown: PARTS, PATIENT CONNECTIONS and PATIENT CIRCUITS, the following a) Determine whether the EQUIPMENT has an APPLIED PART and if it has, identify the extent of the APPLIED PART (these decisions being based on non-electrical considerations).

Safety precautions are considered acceptable if they provide adequate protection without an undesirable restriction of normal function. Generally it is presumed that EQUIPMENT is operated under the jurisdiction of qualified or licensed persons, that the OPERATOR has the skill required for a particular medical application and that he acts according to the instructions for use. The total safety of EQUIPMENT may consist of: – Protective precautions incorporated in the EQUIPMENT (unconditional safety).

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