active medical devices
Active Medical Devices
Any medical device operation of which depends on a source of electrical energy or any source of power other than directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to active medical devices.
Services of the Department "Active Medical Devices":
- Performing of all conformity assessment processes for all active medical products pursuant to the MDD; AIMD, IVDD Directives among others:
- Performing of laboratory tests (electrical safety, mechanical safety, performance tests), also as an extended workbench for manufacturers
- Certificates and approval marks referring to specific product features
- Assessment of safety related issues and assessment of solution models
- Assessment of the functional safety of active medical devices(safety of hardware and software)
- Assessment of the usability of active medical devices
- CB procedures for international approval of tests according to IEC 60601-1, IEC 60601-1-1 and selected 2 standards (IEDC 60601-2-X)
- Compatibility examinations for products in the field of infusion and dialysis
- Assessment of the data security of software in hospitals
- Certification of quality assurance systems of dialysis clinics and dialysis units in hospitals (Good Dialysis Practice)
