Developed by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), the EN 60601-1-6 standard describes the general characteristics and test methods for basic safety and performance for electrical medical equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-1-6 Electrical medical equipment - Part 1-6: General rules for basic safety and required performance - Auxiliary standard: Ease of use.
This standard, which does not complement the EN 60601-1 standard, provides an improved process for a manufacturer to determine, design and verify the usability regarding the basic safety and basic performance of medical electrical equipment. This standard evaluates and aims to reduce the risks arising from the problems regarding the correct use and usage errors of electrical medical equipment. If this standard is followed, it is assumed that the risks defined in the ISO 14971 standard are acceptable if the usability engineering process is followed and the acceptance criteria included in the standard in the usability verification plan are met (TS EN ISO 14971 Medical devices - Application of risk management to medical devices).
The purpose of the EN 60601-1-6 standard is to specify general requirements in addition to general standards and to provide a basis for specific standards. This standard has been revised to be compatible with the usability engineering process in the IEC 62366 standard.
Our organization also provides basic safety and performance testing services for EN 60601-1-6 electrical medical equipment within the scope of laboratory services to enterprises.
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