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Medical Device Testing - Biocompatibility (ISO 10993 )

Biocompatibility testing is required for most sterile and non-sterile medical devices that come into direct or indirect contact with the human body. US FDA or CE Notified body does not approve or recommend any lab for biocompatibility testing, but an accredited lab is preferred for CE Marking. The Medical device manufacturer can choose any lab but the test must be performed as per approved protocol.

Points to Consider in Biocompatibility Tests

  • Intended use of the device
  • The risk assessment should evaluate the final finished device
  • Tests required (cytotoxicity, sensitization, irritation, systemic toxicity, etc.)
  • Testing must be done on final finished device (if possible)
  • Test article - dimensions, manufacturing conditions, sterilization, etc...
  • Extraction conditions - duration, temperature, extraction ratio, etc...
  • Test both polar and nonpolar solvents (if applicable )

A complete test reports must be inculded in FDA 510k submission and CE Marking technical file, the report should included

  • Complete test protocol with deviations, if any
  • Description about the test specimen
  • Summary of the method used
  • Extraction method
  • Test parameters
  • Acceptance criteria
  • Analysis of Results
  • Test Conclusions

LMG will assist you to find out a testing lab where your medical device testing can be performed at a reasonable cost. We can help you with below tests

  • Cytotoxicity
  • Sensitization - Guinea Pig Maximization Test
  • Irritation or Intracutaneous Reactivity
  • Acute Systemic Toxicity
  • Material-Mediated Pyrogenicity
  • Subacute/Subchronic Toxicity
  • Hemocompatibility