EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC 601-1 testing. This standard is a standard that contains the rules and requirements related to the basic safety and necessary performance of electrical medical equipment and electrical medical systems.
This standard electrical medical device has criteria against wear and abrasion 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.
This standard presents 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 this standard product; user manual etc. specifies requirements regarding the content of documents.
This standard provides requirements and criteria according to the class of electrical medical device. Grounding of the electrical medical device, insulation, leakage current levels and other requirements are within the scope of the standard.
This standard provides requirements for medical devices with software for design and use. There are references to the IEC 62304 standard in these matters.
This standard states that the electrical medical device should not create a dangerous situation for the operator and the patient when the use specified and foreseen by the manufacturer is provided. There are test protocols and criteria in these matters.
EUROLAB assists manufacturers with IEC 601-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
