Testing of Medical Devices

Testing of Medical Devices

Medical devices that come into contact with the human body are required by the regulatory authorities to be tested on possible interactions and potential unwanted side effects. Therefore, medical devices are assigned to different categories dependent on the kind of contact and the contact time to the human body.

Different ISO 10993 standard tests for Medical devices are,

  • ISO 10993-3:????Genotoxicity, carcinogenicity and? reproductive toxicity
  • ISO 10993-4:????Selection of tests for interaction with blood
  • ISO 10993-5:????Tests for in vitro cytotoxicity
  • ISO 10993-6:????Tests for local effects after implantation
  • ISO 10993-10:?? Tests for irritation and skin sensitization
  • ISO 10993-11:?? Tests for systemic toxicity

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