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Rules - IVDD

Product Requirements

The "Essential Requirements" for the products can be divided into five general and a large number of more specific requirements:

The general requirements:

  • High level of safety

  • Inherently safe design and construction

  • Suitability

  • Performance stability

  • Transport safety

The specific requirements:

  • Safe materials

  • Sterilization safety

  • Mechanical safety

  • Electromagnetic compatibility

  • Fire and explosion resistance

  • Accuracy and stability

  • Radiation protection

  • Electrical safety

  • Stricter requirements for devices for self-testing

  • Labeling requirements

  • Requirements for instructions

To assist individual manufacturers special harmonized standards that offer interpretations of acceptable levels to fulfill the "Essential Requirements" have been prepared.




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