The EN 60601-1 standard, developed by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of 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 Electrical medical equipment - Part 1: General rules for basic safety and required performance.
Manufacturers who produce medical electrical equipment and want to enter the European market must comply with the medical device directives in force. The mentioned medical device directives cover basic requirements that must comply with harmonized standards. This legal regulation obliges all companies producing electrical medical equipment to understand and meet the requirements of the EN 60601 standard.
The EN 60601 set of standards is a set of standards covering the safety, basic performance and electromagnetic compatibility of electrical medical equipment and systems. It is technically equivalent to the international IEC 60601 standard and consists of over seventy standards.
The EN 60601-1 standard includes basic safety and basic performance criteria for all electrical medical equipment. The EN 60601-2 standard is special standards and includes requirements for certain product groups. The EN 60601-1 standard applies to all electrical medical equipment and systems.
This standard covers a wide variety of medical equipment. High frequency surgical equipment, cardiac defibrillators, patient monitors, treatment and diagnostic ultrasound devices, medical lasers, patient ventilators, and pediatric incubators and warmers are covered by this standard. Tests demonstrating compliance with this standard require a detailed understanding of the requirements together with special test equipment.
Our organization also provides businesses with basic safety and performance testing services for electrical medical equipment in accordance with EN 60601-1, as part of our laboratory services .
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