IEC/EN 60601-1 Requirements for Equipment, Basic Safety and Required Performance of Medical Electrical Devices

The IEC EN 60601-1 standard is a standard that contains the rules and requirements for the basic safety and necessary performance of electrical medical equipment and electrical medical systems. The IEC EN 60601-1 standard, which addresses most of the risks associated with electronic medical devices, has become a de facto requirement by most institutions and organizations for electro-medical products.

The IEC EN 60601-1 standard provides requirements for the risk management file prepared for the device in order to identify and control the risks that may arise from the use of the electrical medical device. There are references to the EN ISO 14971 standard in these matters.

IEC EN 60601-1 standard has criteria against wear and abrasion of the electrical medical device during the specified lifetime of the device. Medical devices with moving parts are available in the IEC EN 60601-1 standard with the necessary criteria for the operator, patient and environment.

The IEC EN 60601-1 standard provides the requirements for the labels, signs and symbols on the electrical medical device. The test for erasure, wear and deformation of these marks and symbols is defined in the protocols.

For example, the documents given with the IEC EN 60601-1 standard product; user manual etc. specifies requirements regarding the content of documents.

The IEC EN 60601-1 standard provides requirements and criteria according to the class of the electrical medical device. Grounding of the electrical medical device, insulation, leakage current levels and other requirements are within the scope of the standard.

The IEC EN 60601-1 standard provides requirements for medical devices that contain software for design and use. There are references to the IEC 62304 standard in these matters.

The IEC EN 60601-1 standard states that the electrical medical device should not create a dangerous situation for the operator and the patient when provided for the use specified and foreseen by the manufacturer. In these matters, there are test protocols and criteria in the IEC EN 60601-1 standard.

Among the numerous test, measurement, analysis and evaluation studies, our organization, with its trained and expert staff and advanced technological equipment, within the framework of national and international standards, offers IEC / EN 60601-1 for Equipment, Basic Safety and Required Performance of Electrical Medical Devices to the requesting enterprises. Requirements provides testing services.