Meeting regulations with medical electrical equipment standards
The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities.
If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives.
What is BS EN 60601?
BS EN 60601 series is a group of standards that cover the safety, essential performance, and electromagnetic compatibility of medical electrical equipment and related systems.
It is equivalent to the international standard EN 0601 and comprises over 70 individual standards. These start with BS EN 60601-1 ‘Part One’, which covers basic safety and essential performance for all medical electrical equipment, and then ‘Part Two’ or ‘Particular’ standards, which include the requirements for specific product groups (e.g. BS EN 60601-2-22 Medical electrical equipment. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment).
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Complying with BS EN 60601-1
BS EN 60601-1 applies to all medical electrical equipment and medical electrical systems. Medical electrical equipment is defined in the standard as electrical equipment, which:
has an applied part – the part of the medical electrical equipment that, in normal use, necessarily comes into physical contact with the patient for the medical electrical equipment or system to perform its function
transfers energy to or from the patient or detects such energy transfer to or from the patient.
The medical electrical equipment should be provided with only one connection to a particular mains supply and the intended use, as described by the manufacturer, should be in the diagnosis, treatment, or monitoring of a patient, or to alleviate or compensate for disability, disease or injury.
Examples of devices classed as medical electrical equipment include:
Cardiac defibrillators
High-frequency surgical equipment
Infant incubators and warmers
Medical lasers
Patient monitors
Patient ventilators
Ultrasound equipment – diagnostic and therapeutic
Other Key Medical Electrical Equipment Standards
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration, and haemofiltration equipment
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electroencephalographs
Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement
There is no doubt that using standards can help you comply with the necessary regulations in the manufacturing of your medical equipment, building crucial trust between you and the rest of your supply chain. With a BSI Knowledge subscription, quality, risk management, and compliance are at your fingertips. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module for instant access to over 4,800 documents. Request to learn more.
Ensure your electrical medical device complies with industry regulations by adding these standards to your collection today.