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Biocompatibility Testing

Biocompatibility testing determines how compatible a medical device is with the human body and whether its use causes any harmful effects. Material characterization is first conducted to analyze device components. In vitro testing of device extracts is then performed, followed by in vivo animal tests ranging from skin irritation to implantation, depending on the intended use. Biocompatibility testing can take 3 weeks to several months depending on the specific tests required. Pacific BioLabs offers various biocompatibility tests according to ISO 10993 standards to support FDA and international regulatory submissions.

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301 views2 pages

Biocompatibility Testing

Biocompatibility testing determines how compatible a medical device is with the human body and whether its use causes any harmful effects. Material characterization is first conducted to analyze device components. In vitro testing of device extracts is then performed, followed by in vivo animal tests ranging from skin irritation to implantation, depending on the intended use. Biocompatibility testing can take 3 weeks to several months depending on the specific tests required. Pacific BioLabs offers various biocompatibility tests according to ISO 10993 standards to support FDA and international regulatory submissions.

Uploaded by

Aprillia Anggasari
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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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 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)

Typically, material characterization and analysis of a devices components are conducted prior to any biological testing. This involves extracting leachable materials from the device or components at an elevated temperature, and analyzing the leachab extracts for potentially harmful chemicals or cytotoxicity.

Once in vitro testing has been completed, in vivo biological testing can be done based upon the devices intended use. This testing can range from skin irritation testing to hemocompatibility and implantation testing. Turnaround time for tests can rang from three weeks to greater than several months, depending on the specific test data needed. Subchronic or chronic implanta testing can last even longer.

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

Available Biocompatibility Tests

Cytotoxicity o Agarose Overlay o MEM Elution o Direct Contact o MTT Assay (quantitative) Hemocompatibility o JP Hemolysis Test o ASTM Hemolysis Implantation Testing o USP Intramuscular Implantation o ISO Subcutaneous Implantation o ISO Intramuscular Implantation Irritation / Intracutaneous Reactivity o USP / ISO Intracutaneous Reactivity o ISO Mucosal Irritation (vaginal, rectal, oral) o ISO / FSHA / OECD Ocular Irritation o Intraocular Irritation o ISO / EPA / OECD Dermal Irritation Sensitization o ISO / EPA Closed Patch (Beuhler) Dermal Irritation o ISO Maximization Test o ASTM, NIH LLNA Systemic Toxicity - ISO Acute Systemic Toxicity

Pyrogenicity

o USP / CFR Pyrogen Test o ISO Rabbit Pyrogen - Material Mediated o JP Rabbit Pyrogen Test USP Plastics (USP Class VI) o USP I-VI o USP Systemic Injection Test o USP Intracutaneous Test o USP Implant Test o USP Safety Test

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