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Safety testing according to IEC 60601-1

Safety standard for active medical devices

IEC 60601-1 is the basic safety standard for active medical devices. In addition to many laboratory tests carried out directly on the tested device, it also includes the review of referenced tests and also the review of technical documentation.

The test reports listed below must – if applicable – be submitted at the end of the IEC 60601-1 test or commissioned at the same time:


Test reports

  • DIN EN 60529 IP protection
  • ISO 10993 Biocompatibility
  • IEC 60601-1-2 Collateral standard for EMC
  • IEC 60601-1-6 Collateral standard on suitability for use
  • IEC 60601-1-8 Collateral standard on alarm systems
  • IEC 60601-1-10 Collateral standard on physiologically closed loops
  • IEC 60601-1-11 Collateral standard for medical equipment in a domestic environment
  • IEC 60601-1-12 Collateral standard for medical systems in emergency medical services


Other documents to be checked

  • Instructions for use
  • Risk management file according to ISO 14971
  • Software documentation according to IEC 62304
  • Test reports of components such as power supply units or critical components

The specific documents that must be available for the test will be agreed individually within the scope of the order clarification.

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Additional test standards

IEC / DIN EN 61010-1

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

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IEC / DIN EN 61010-2-101

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

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