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Medical Device Biocompatibility Testing to ISO 10993

ANSWERED ON THIS PAGE:

  • Does ISO 10993 apply to our medical device?
  • What are the different types of biocompatibility tests?
  • Which tests are required for our device?

For medical devices that directly or indirectly contact patients, biocompatibility testing is required to obtain regulatory approval in most markets. Biocompatibility tests help determine whether a device performs as intended without causing any adverse or harmful effects for patients or users, and mitigate any biological risks posed by the device.

ISO 10993 is the key standard used for medical device biocompatibility testing. The standard has 20 parts, but its most widely recognized component is ISO 10993-1:2009, “Biological evaluation of medical devices. Part 1: Evaluation and testing.”

Some market regulators such as the US FDA require additional biocompatibility evaluation beyond ISO 10993. FDA requirements are explained in the guidance document Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management framework.

Determining suitable biocompatibility testing under ISO 10993

Emergo’s parent company UL has decades of expertise assisting medical device companies with biocompatibility testing. UL offers testing services in accordance with ISO 10993, as well as additional testing requirements from individual market regulators. Identifying and conducting appropriate biocompatibility tests under ISO 10993-1 helps avoid delays in regulatory approvals. Our team can help determine applicable biocompatibility tests based on your device type, intended use, and nature and duration of contact with patients.

Before conducting ISO 10993-1 biocompatibility testing, manufacturers may need to conduct extensive physical and chemical testing according to ISO 10993-18:2005, which we can also support.

We can help you comply with ISO 10993 biocompatibility testing requirements

We support biocompatibility testing based on ISO 10993-1:2009 requirements, and conduct all tests according to Principles of Good Laboratory Practice (GLP). Our comprehensive portfolio of biocompatibility tests includes:

  • Cytotoxicity
  • Genotoxicity
  • Sensitization
  • Implantation
  • Irritation
  • USP biological reactivity
  • Intracutaneous reactivity
  • Hemocompatibility
  • Systemic toxicity
  • Pyrogen

 

For many devices, conducting biocompatibility testing is an essential step in the regulatory approval process. Let us apply our expertise in medical devices to ensure that you meet all applicable requirements and work with the most qualified technicians with experience in your device materials.

Contact us for more information on ISO 10993 and biocompatibility testing support

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