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