Biocompatibility - Toxicity Testing Procedure | ISO 13485 | FDA QSR Compliant
SKU: SOP 7-034
The ISO 13485 Biocompatibility Procedure governs the biological evaluation of medical devices. The Biocompatibility Procedure is aligned with ISO 10993 and FDA Guidance.
- ISO 10993 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
The ISO 13485 Biocompatibility Procedure establishes a process for assuring the biocompatibility of medical device materials address the ISO 10993 requirements for the intended use of the medical device.
Biocompatibility Procedure Overview
The ISO 13485 Biocompatibility Procedure applies to the biocompatibility evaluation of medical device materials, components and finished medical devices. The ISO 13485 Biocompatibility Procedure includes a sample protocol and final report that provides guidance on overall structure and required content of a protocol and final report.
The risk assessment should evaluate the medical device in its final finished form. The risk assessment should evaluate not only the materials used in the device, but also the processing of the materials, the manufacturing methods (including the sterilization process), and any residuals from manufacturing aids used during the process.
Identification of potential risks
An assessment of potential biocompatibility risk should include not only chemical toxicity, but also physical characteristics that might contribute to an unwanted tissue response. These characteristics can include surface properties, forces on surrounding tissue (e.g., mechanical, thermal, electromagnetic), geometry, and presence of particulates, among others. In addition, changes in manufacturing and processing parameters can also have an impact on biocompatibility.
Biocompatibility Testing Considerations
Final finished form. When biocompatibility testing is necessary, test the medical devices in the condition that they will be used, whenever possible. This could include final, packaged devices, or as sterilized by an end user, if appropriate.
In Situ polymerizing and / or absorbable materials. For devices made from in situ polymerizing and/or absorbable materials, the test article preparation should be representative of the device in its final finished form.
Inclusion of multiple components or material in a single test article. For devices that include components with different lengths of contact (e.g., categorized as limited, prolonged, or permanent), extract-based biocompatibility testing should be conducted separately.
Biocompatibility Procedure Compliance
The ISO 13485 Biocompatibility Procedure is ISO 10993, FDA 21 CFR Part 820 and ISO 13485:2016 compliant.
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