EUROLAB laboratory provides testing and compliance services within the scope of the IEC 62353 standard. IEC 62353 applies to the testing of medical electrical equipment and medical electrical systems, hereinafter referred to as ME equipment and ME systems, or parts of such equipment or systems that comply with IEC 60601-1 and its amendments.
For equipment not made according to IEC 60601-1, these requirements can be used taking into account the safety standards for the design and information in the operating instructions for that equipment. This standard contains tables with allowable values for different versions of IEC 60601-1.
For the purpose of this standard, the application of measurement methods is independent of the version for which the ME equipment or ME system is designed. This standard includes "general requirements" and "special requirements", which include clauses of general interest, other clauses that deal with special types of ME equipment or ME systems and apply in conjunction with "general requirements".
This standard is not suitable for evaluating whether ME equipment or ME systems or any other equipment conforms to the relevant standards for their design. This standard is not applicable to the assembly of ME systems.
All maintenance, inspection, service and repair according to the manufacturer's instructions ensure compliance with the standard used for the design of the equipment. Otherwise, compliance with applicable requirements should be evaluated and verified before tests of this standard are carried out. This standard can also be applied to tests after repair.
EUROLAB assists manufacturers with IEC 62353 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.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
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.
