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...

1. Considerations for Biocompatibility Evaluation
By: Nikita Angane
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
o Surface devices that could have contact with intact skin, mucosal
membrane, breached or compromised surface.
o External communicating devices that could have contact with blood path,
tissue, bone, dentin, or circulating blood and
o 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

2. Page 2 of 2
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.
1 FDA (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