The medical devices industry constantly produces high quality, high technology and high performance products in order to increase patient safety. The electronic devices used for medical purposes seek to ensure safety and compliance with critical care equipment, while at the same time trying to meet important safety and performance requirements to reduce unacceptable risks for patients.
In short, medical device regulations cause manufacturers to face a number of compatibility issues. In this respect, electrical medical device tests performed in advanced laboratories ensure electrical product safety by complying with standards such as ISO 60601 and ISO 14708, and ensuring electromagnetic compatibility (EMC) and RFID (radio frequency identification technology) sensitivity.
There are three main legal regulations in force in the European Union countries: the Medical Devices Directive 93 / 42 / EEC, the Active Implantable Medical Devices Directive 90 / EEC and the 385 / 98 / EC External Diagnostic Medical Devices Directive.
Product safety requirements for electrical medical devices are documented and harmonized internationally under the ISO 60601 standard family, which forms the basis of the approval procedure for medical electrical equipment worldwide. This standard specifies various test conditions for protection against potential electrical hazards.
In addition, the standards developed by the International Electrotechnical Commission (IEC) for in-service and post-repair testing of electromedical devices set new requirements.
The following are a few standards that are based on electrical medical device testing by competent authorities:
TS EN 60601-1 Electrical and medical equipment - Part 1: General requirements for basic safety and performance
ISO 14708 Implants for surgery - Active implantable medical devices
TS EN 62353 Electrical medical equipment - Retest and test after repair of electrical medical equipment
The application is received, the contract and then the product, vehicle and vehicles for which, what kind of service is determined exactly.
The necessary laboratory environment is prepared and the products, tools and instruments requested by the organization are tested by experts with the reference of the existing standards and measurements are made.
The data obtained as a result of meticulously completed tests, measurements and analyzes are evaluated and accredited approved reports are submitted by expert engineers.
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