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biocompatibility testing
 

MEDICAL DEVICE BIOCOMPATIBILITY TESTING

Biocompatibility is, by definition, a measurement of how compatible a device is with a biological system. The purpose of performing biocompatibility testing is to determine the fitness of a device for human use, and to see whether use of the device can have any potentially harmful physiological effects. As stated by the International Organization of Standards (ISO):

“The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices.” (ISO 10993-1:2009)

Device Leachables and Extractables and In Vitro Biocompatibility

Typically, material characterization and analysis of a device’s components, also known as device leachables and extractables testing, is conducted prior to any biological testing. This involves extracting leachable materials from the device or components at an elevated temperature, and analyzing the leachable extracts for potentially harmful chemicals or cytotoxicity. This aspect of biocompatibility has become increasing important over the last several years.

In Vivo Biocompatibility Testing

Once in vitro testing has been completed, in vivo biological testing is performed, with the extent of type of testing to be performed based upon the device’s intended use. This testing can range from skin irritation testing, to hemocompatibility/hemolysis testing, and implantation testing. Turnaround time for tests can range from three weeks to greater than several months, depending on the specific test data needed. Subchronic or chronic implantation testing can last even longer.

For an in-depth exploration of biocompatibility, methods, and related tests, visit our Learning Center section on Assessing Biocompatibility.

Available Biocompatibility Testing Services

  • Material/Chemical Characterization (ISO 10993-18)
  • Cytotoxicity
    • Agarose Overlay
    • MEM Elution
    • Direct Contact
    • MTT Assay (quantitative)
  • Hemocompatibility
    • JP Hemolysis Test
    • ASTM Hemolysis
  • Implantation Testing
    • USP Intramuscular Implantation
    • ISO Subcutaneous Implantation
    • ISO Intramuscular Implantation
  • Irritation / Intracutaneous Reactivity
    • USP / ISO Intracutaneous Reactivity
    • ISO Mucosal Irritation (vaginal, rectal, oral)
    • ISO / FSHA / OECD Ocular Irritation
    • Intraocular Irritation
    • ISO / EPA / OECD Dermal Irritation
  • Sensitization
    • ISO / EPA CLosed Patch (Buehler) Dermal Irritation
    • ISO Maximization Test
    • ASTM, NIH LLNA
  • Systemic Toxicity - ISO Acute Systemic Toxicity
  • Pyrogenicity
    • USP / CFR Pyrogen Test
    • ISO Rabbit Pyrogen - Material Mediated
    • JP Rabbit Pyrogen Test
  • USP Plastics (USP Class VI)
    • USP I-VI
    • USP Systemic Injection Test
    • USP Intracutaneous Test
    • USP Implant Test
    • USP Safety Test

Pacific BioLabs is a preclinical CRO that has been assisting medical device companies with FDA IDE and 510k, as well as international regulatory submissions for many years. We offer testing performed according to ISO 10993, compliant with major regulatory bodies. Our animal programs are AAALAC accredited, and we carry ISO 9001:2008 and ISO 13485:2003 certifications.

 
 
 
Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.
   
   

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