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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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Dr. Benjamin Weber
Head of Laboratory

Additional test standards

IEC / DIN EN 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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IEC / DIN EN 61010-1

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements.

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