Current problems in standardization of electrical safety requirements for medical devices

AbstractThe purpose of the paper is to present the issues of ensuring the safety of machinery and equipment in accordance with the requirements of the Machinery Directive 2006/42/EC of May 17, 2006 on the essential requirements for machines, with regard to the sphere of their import and distribution. This issue is related to the dynamically developing trade in cheaper new machines, mainly from countries outside the EEA (including China) and is a priority for ensuring safety and protecting the health and life of users of this type of equipment in accordance with EU regulations. The use of a variety of machines in industry, in addition to general safety requirements, which may also include quality criteria, care for the environment and industry-specific safety management requirements (e.g. food, automotive, medical devices).

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Why Should We Have a Periodic Safety and Performance Program for Medical Devices

Journal of Biomedical Physics and Engineering ◽

10.31661/jbpe.v0i0.761 ◽

2018 ◽

Author(s):

A Tavakoli Golpaygani

Keyword(s):

Quality Control ◽

High Risk ◽

Medical Devices ◽

Medical Equipment ◽

Control Program ◽

Electrical Safety ◽

Leakage Currents ◽

Quality Control Program ◽

Periodic Safety ◽

And Performance

Nowadays, more than 10,000 different types of medical devices can be found in hospitals.These devices used in medical centers and hospitals for monitoring and treatment of patients require periodic safety and performance checking in order to have confidence in their functioning and operation. Physicians need better accurate medical measurements in order to better diagnose diseases, monitor patients and deliver treatments, in this way failure to ensure appropriate measurements will certainly have diverse effects. Safety and performance testing of medical devices in the medical sector is a one of the key factor in improving public health. Acquiring results of some investigations indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in highrisks instruments.The metrological reliability of four high risk medical devices, Electrosurgical unit, Defibrillator, Syringe pump and Infant incubator in use some hospitals (privates and publics) in one of the province of Iran according to international and national standards was evaluated. Quantitative analysis of Some parameters that impact the safety and performance showed the amount of the obtained results in some equipment are in critical range and have higher values than standard limitations. General electrical safety evaluations for measuring the patient leakage currents and patient auxiliary currents carried out for all of groups,in some cases the amount of leakage currents were over the standard limitations.Acquiring results indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in high risk instruments. It is also necessary provide training courses for operating staff in the field of meterology in medicine and what’s the critical parameters and how they can get good accuracy results equipment.

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