IEC 80601-2-30 Medical Electrical Equipment - Special Requirements for Basic Safety and Basic Performance of Automatic Non-Invasive Blood Pressure Monitors

IEC 80601-2-30 applies to the basic safety and basic performance of automatic blood pressure monitors used through an inflatable cuff for intermittent indirect measurement of blood pressure without arterial puncture. The measurement of blood pressure without electrically powered intermittent, indirect arterial puncture covers ME equipment with automated methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment.

Requirements for indirect estimation of blood pressure without display arterial puncture ME equipment with an electrically powered pressure transducer or with a stethoscope or other manual methods for determining blood pressure (non-automatic sphygmomanometers) are specified in ISO 81060.

This edition constitutes a major technical revision as well as compliance with the third edition of IEC 60601-1.

Specific technical changes include:

• Identification of baseline performance, where the patient is the operator;
• New clinical accuracy requirements, additional mechanical strength requirements;
• Expanding coverage to include all automatic blood pressure monitors, including banning operator accessible 'Luer' connectors on the pneumatic system.

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