BS EN 60601-2-34:1995 Medical electrical equipment. Part 2. Particular requirements for safety - Section 2.34 Specification for direct blood-pressure monitoring equipment
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BS EN 60601-2-34:1995 is a European standard that specifies the safety requirements and testing methods for ambulatory electrocardiographs. These are medical devices used to measure and record the electrical activity of the heart of patients while they go about their daily activities, typically to diagnose or monitor cardiac disorders.
The standard covers several aspects of safety, including electrical safety, mechanical safety, and fire safety. It also specifies requirements for electromagnetic compatibility, user safety, and accuracy of measurements. The standard provides guidance on the testing procedures for these safety requirements.
In addition, the standard specifies requirements for the labeling and documentation of ambulatory electrocardiographs, including information on their safety features and operating instructions.
It is important to note that this standard has been superseded by the updated version, EN 60601-2-47:2012. This newer version includes additional safety requirements and updated testing procedures to reflect advances in technology and changes in industry practices.
This clause of the General Standard applies except as follows:
Addition:
This Particular Standard applies to DIRECT BLOOD-PRESSURE MONITORING EQUIPMENT as defined in 2.101, hereinafter referred to as EQUIPMENT.
This Particular Standard does not apply to catheter tubing, catheter needles, Luer locks, taps and taptables, etc.
This Particular Standard also does not apply to indirect blood-pressure monitoring equipment.
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of DIRECT BLOOD-PRESSURE MONITORING EQUIPMENT and the electrical safety requirements for CATHETER TIP TRANSDUCERS as defined in 2.103.
BS EN 60601-2-34:1995 Medical electrical equipment. Part 2. Particular requirements for safety - Section 2.34 Specification for direct blood-pressure monitoring equipment