Considerations for Biocompatibility Evaluation

by | May 20, 2021 | Biocompatibility, FDA, Gene and Cell Therapies, Medical Devices, Pharmaceuticals, Regulatory, Testing

Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their product development process. ISO 10993-5 and ISO 10993-10 are FDA-recognized standards for biocompatibility. Whether you perform these studies in-house or send out samples to a third-party lab the protocol for biocompatibility assessment must be conducted in accordance with ISO 10993.

13 types of biological effects must be tested depending on the body contacting device:1

  • Cytotoxicity
  • Sensitization
  • Irritation
  • Material-Mediated Pyrogenicity
  • Subacute/Subchronic Toxicity
  • Genotoxicity
  • Implantation
  • Hemocompatibility
  • Chronic Toxicity
  • Carcinogenicity
  • Reproductive/Developmental Toxicity
  • Degradation

When deciding which type of biological effect needs to be tested the following factors must be considered:1

  • Nature of body contact of the product, which depends on the category of the product and the body contacting surface, such as
    • Surface devices that could have contact with intact skin, mucosal membrane, breached or compromised surface.
    • External communicating devices that could have contact with blood path, tissue, bone, dentin, or circulating blood and
    • Implantable devices that could have contact with tissue, bone, or blood.
  • Contact duration of the device with the surfaces mentioned above. The contact duration as per ISO 10993 is defined as limited duration which is ≤24 hours, prolonged duration which is >24 hours to 30 days, and devices that are permanently in contact with the body surface which is > 30 days.

Whether you are in the product development stage or conducting these tests for a pre-market submission, determining which tests to conduct can always seem confusing, but EMMA International is always there to assist you in all of your product development and regulatory needs.

Call us today at 248-987-4497 or email us at info@emmainternational.com to learn more.


1FDA (Sept 2020) Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” retrieved on 05/18/2021 from https://www.fda.gov/media/85865/download

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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