DR 92151被替代
Approval and test specification - Medical electrical equipment Part 2.X: Particular requirements for safety - Transcutaneous partial pressure monitoring equipment
出版：Standards Australia
专家解读视频
Proposes requirements for the electrical safety of a device and associated transducers for the monitoring or recording of partial pressures of gases at the skin surface, or both. It applies to monitors used with adults and neonates but does not include the devices used in foetal monitoring during birth. It does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (e.g. conjunctiva or mucosa). This proposed Standard is one in a series of Approval and Test Specifications to be issued by Standards Australia and Standards New Zealand for individual items of medical electrical equipment. It is to be supplementary to AS 3200.1-1990/NZS 6150-1990 Approval and test specification - Medical electrical equipment, Part 1: General requirements for safety, and technically equivalent to IEC/62D(CO)50.
