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Reference project
Equipment evaluation of a new blood glucose meter
A customer intends to provide proof of the environmental compatibility and usability of blood glucose meter while ensuring, at the same time, that the warranted equipment properties are met.
Implementation
Electrical and mechanical testing for conformity assessments regarding equipment safety, type testing for conformity assessments of components, equipment and equipment systems:
Medical electrical equipment as per DIN EN 60601-1
- Equipment for measurement, control, and laboratory use as per DIN EN 61010-1
- Electrical equipment of machines as per DIN EN 60204-1
- IVD products as per DIN EN 61010-2-101
- ME equipment systems as per DIN EN 60601-1-1
- Information technology equipment as per DIN EN 60950-1
- Usability as per DIN EN 60601-1-6
- Evaluation and logging
We perform zero-tolerance verification
Customer benefit
Safe products thanks to functional tests regarding:
- Electromagnetic compatibility (EMC)
- Electrostatic discharge (ESD)
- Thermals loads
- Mechanical loads and environmental impact
Client
Manufacturer of medical devices and diagnostic equipment, Germany