Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
Update: 30 October, 2023
This standard specifies the general requirements for the basic safety and essential performance of medical electrical equipment, including terms and definitions, general requirements, general requirements for the test of ME equipment, classification of ME equipment and ME systems, ME equipment identification, marking and documentation, ME equipment protection against electric shock hazard, ME equipment and ME systems protection against mechanical hazards, protection against unnecessary or excessive radiation hazards (sources), protection against overheating and other hazards (sources), protection of accuracy and hazardous output of controllers and instruments, dangerous states and fault conditions of ME equipment, programmable medical electrical systems (PEMS), ME equipment structure, ME systems, and ME equipment and ME systems electromagnetic compatibility.
File format: PDF
Size: -
MD5 Checksum: 2691132AFB24ABDC0B2AC825BF7FF5E6
Publication date: 30 October, 2023
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Medical electrical equipment—Part 1: General requirements for basic safety and essential performance PDF