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Scope (English)

This standard provides the necessary basics of safety and performance for respiratory gas monitors. Indicate the requirement for anesthesia gas monitor, carbon dioxide monitor, and oxygen gas monitor. This standard defines the introduction, scope, purpose and related standards, reference documents, definitions, general requirements, general requirements for testing medical appliances, types of medical appliances and electrical systems, identification of markings and documentation of medical electrical appliances, protection against electrical hazards from medical electrical appliances, protection against mechanical hazards of medical electrical appliances and electrical systems, protection against unwanted or excessive radiation, protection against over-temperature and other hazards, the precision of control and operating procedures and protection, hazardous and faulty conditions of medical electrical appliances, medical electrical program, medical electrical appliance structure, medical electrical appliance, electromagnetic compatibility of medical electrical appliance and electrical appliance system, gas or vapor effect, gas leakage, connection port for respiratory monitor conversion, minimal sampling flow, respiratory contamination, functional connection, air disturbance electromagnet – requirements and tests, functionality, general requirements, tests and recommendations for alarm systems in medical appliances and electrical appliance systems, requirements for electrical appliances and electrical appliance systems for use in supervision home, and environmentally conscious design requirements