Medical Electrical Equipment - Regulation and Standards

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IET Birmingham: Austin Court


B1 2NP

United Kingdom

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Event description


Nearly all of the medical devices tested against IEC/EN 60601-1, 3rd Edition, fail at least some tests. This can lead to delayed product launch, lost revenues and increased development costs. It can also be avoided.

In 2005, the third edition of IEC 60601-1 was published. It was the result of a comprehensive review of the second edition (dating from 1988). Some key changes are: the outline and the numbering scheme of the clauses and subclauses were changed, risk management was made much more relevant and the concept of essential performance was added. IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 3rd edition series.

What You Will Learn

Upon completion of this seminar, participants will understand:

Risk management process

· Risk analysis

· Risk assessment

· Risk/benefit assessment

· Risk monitoring

· Software

Medical devices safety

· Essential requirements

· Fault conditions

· Safety concept

Application safety

· Usability

· Clinical assessment

· Biocompatibility

· Hygiene

Interference with the environment

· Environmental conditions

· Electric installation

· Electrostatic discharges

· Interference by magnetic fields

· Interference by radiofrequency electromagnetic fields

Impact on the environment

· Electromagnetic Emissions

· Fire and explosion protection

· Ecological safety

Biological aspects

· Body resistance

· Cellular excitation

· Effects of electric currents

· Electric current density

Limitation of Voltages

· Safety voltages

· Patient environment

Leakage currents

· Touch current

· Patient leakage current

· Patient auxiliary current

· Earth leakage currents

Safety classes

· Safety class 1 (protective earthing)

· Safety class 11 (protective insulation)

· Safety class battery devices

General safety requirements

· Device classification

· Alarms

· Safety testing

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IET Birmingham: Austin Court


B1 2NP

United Kingdom

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