IEC 60601-1 standard is the safety standard of Electrical Medical Devices. According to developing world in technology and science, we always keep ourselves up to date and ready for new requirements. In addition to providing test services to our customers with our experienced and dynamic staff in general standards and product-based standards of electrical medical devices, R&D opportunities and trainings are our other activities. As LVT Test Laboratories, it is our primary goal to provide an efficient, fast, and reliable service in every project.
The IEC 60601-1 standard does not only consist of tests and inspections. The documentation and component selections prepared by the manufacturers have an important place in the content of the standard.
-Detailed drawings of the products
-Software validations prepared according to EN / IEC 62304 standard
- User manuals & technical instructions that will contain detailed and necessary information.
-Components list & certificates
-Isolation diagrams
-Label sample including marking required
-Biocompatibility analysis
-MSDS forms for plastic materials
-Usability reports prepared in accordance with the IEC 60601-1-6 standard
-Alarm reports (audio & visual) prepared in accordance with IEC 60601-1-8 standard
- The risk analysis must be submitted to the laboratory with the product by the manufacturer.
Determination of which tests to be performed, essential performance control, insulation verifications, single fault tests are carried out based on this documentation.
Document control is especially important in determining conditioning times, performing leakage current and dielectric tests, mechanical applications and component competence.