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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 It is important to note that this standard has been superseded by the updated version, EN 60601-2-47:2012.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.
Contributor(s):
MAR - Data Entry Person
Primary Item Type:
British Standard
Identifiers:
ISBN 0580246779
ICS 11.040.55 Diagnostic equipment
Language:
English
Subject Keywords:
Electrical equipment; Clearance distances; Instructions for use; Pressure testing; Cardiology; Leakage currents; Electronic equipment and components; Marking; Performance testing; Electrical safety; Safety measures; Medical equipment; Electrical medical equipment; Clinical investigation instruments; Transducers; Safety; Leakage paths; Safety engineering; Testing conditions; Watertightness tests; Protected electrical equipment; Defibrillators; Circuits; Sphygmomanometers; Drop tests; Blood pressure; Patient monitors; Accuracy
First presented to the public:
5/26/2023
Original Publication Date:
11/15/1995
Previously Published By:
British Standards Institution
Place Of Publication:
London, United Kingdom
Citation:
Extents:
Number of Pages - 30
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2023-05-26 08:57:30.744
Submitter:
Muhamad Azmil Ramli

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BS EN 60601-2-34:1995 Medical electrical equipment. Part 2. Particular requirements for safety - Section 2.34 Specification for direct blood-pressure monitoring equipment1 2023-05-26 08:57:30.744
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