Biocompatibility is a measurement of how compatible a device or material is with a biological system. The ISO 10993-1: 2018 standard defines biocompatibility as the ability of a medical device or material to perform with an appropriate host response in a specific application".
The term "biocompatibility" describes how a medical device interacts with a patient's tissues and physiological systems while being used to treat them. One aspect of a device's overall safety evaluation is an assessment of biocompatibility. Analytical chemistry, in vitro tests, and animal models are used to investigate the biocompatibility of devices. A device's biocompatibility is influenced by a number of factors, including:
- the physical and chemical composition of its constituent parts
- the time span of that exposure
- patient tissue types that will be exposed to the device
The purpose of performing biocompatibility testing is to determine the fitness of a device for human use and to see whether the use of the device can have any potentially harmful physiological effects. The goal of device designers is to minimize risk while maximizing benefit to patients.
Biocompatibility testing can be divided into three steps: planning, conducting the test, and analyzing the results. Those three steps to demonstrate biocompatibility are stated below:
- Create a Biological Evaluation Plan (BEP). Data on the materials used to make the device should be gathered early in the planning process. The type of testing that is necessary will be determined by a biological evaluation plan (BEP). This examines your device and its materials, identifies potential risks, and suggests possible evaluations or testing to address those risks. The BEP can serve as your initial risk assessment, and you can also share it with the FDA during a free pre-submission discussion.
- Evaluation and testing of devices. This entails performing the tests identified in your BEP. These are typically a combination of in vivo or in vitro biological tests, chemistry tests, and toxicological risk assessments, as well as written assessments based on scientific literature.
- Create a Biological Assessment Report (BER). The results of all tests and evaluations are summarized here. This, along with the test results, is submitted to the manufacturer.
- APPLICABLE STANDARD -
As stated by the International Organization of Standards (ISO 10993-1:2018), “The primary aim of this part of ISO 10993 is the protection of humans from potential risks arising from the use of medical devices. Before performing biocompatibility testing, it is important for the manufacturer to gain a better understanding of the device materials, device manufacturing, sterilization, and other processes. The ISO 10993-1:2018 standard emphasizes chemical characterization before proceeding to in vitro and in vivo biocompatibility testing.
EN ISO 10993-1:2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
If a medical device does not have direct or indirect contact with the patient, then ISO 10993-1 does not apply.
ISO 10993 consists of the following parts, under the general title biological evaluation of medical devices:
⎯ Part 1: Evaluation and testing within a risk management process
⎯ Part 2: Animal welfare requirements
⎯ Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
⎯ Part 4: Selection of tests for interactions with blood
⎯ Part 5: Tests for in vitro cytotoxicity
⎯ Part 6: Tests for local effects after implantation
⎯ Part 7: Ethylene oxide sterilization residuals
⎯ Part 9:Framework for identification and quantification of potential degradation products
⎯ Part 10: Tests for irritation and skin sensitization
⎯ Part 11: Tests for systemic toxicity
⎯ Part 12: Sample preparation and reference materials
⎯ Part 13: Identification and quantification of degradation products from polymeric medical devices
⎯ Part 14: Identification and quantification of degradation products from ceramics
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