Safety tests according to IEC 61010-2-101
Particular Standard for IVD equipment
In addition to the general requirements of the basic standard IEC 61010-1, the requirements of the Particular Standard IEC 61010-2-101 apply to IVD equipment.
The standard defines more precise requirements, e.g. for:
- Gas and liquid connections
- Installation and commissioning
- Use and operation
- Handling of samples that may be hazardous to health
- IVD devices intended for self-testing by the user
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Additional test standards
IEC / DIN EN 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC / DIN EN 61010-1
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements.