Biological Compatibility in Medical Device Development: A Look at the ISO 10993 Standard Series
Authors: Myriam Gueye | Last updated: October 2023
Overview
Developing medical devices requires careful management of biocompatibility risks. The ISO 10993 series provides a framework for Biological Evaluation Planning (BEP) to reduce animal testing through in vitro methods and detailed material analysis. It is crucial to assess every device component for its intended use, contact duration, and potential biological hazards.
To ensure the biological compatibility of a medical device, it is crucial to follow an evidence-based approach that relies on scientific confidence and a risk management process. When evaluating biological risks, it is recommended to use a risk assessment approach that considers the complete ISO 10993 series, providing a broader view.
Download this article to ensure that your medical device development aligns with the latest biocompatibility standards and risk management practices related to ISO 10993.
- Document type: Article
- Page count: 6
- Read time: 10 minutes
Key Takeaways
- Navigate ISO 10993 with confidence and ensure your medical devices meet stringent biocompatibility standards
- Overcome material safety challenges, from chemical characterization to cytotoxicity testing
- Stay informed of regulatory changes affecting gene and cell therapy delivery systems
- Implement robust risk management strategies to mitigate biological risks in device development
- Find out how Sartorius solutions can support your biocompatibility testing and streamline compliance with industry standards
This Resource is Designed for:
- Lab Researchers
- Lab Technicians
- Scientists
- Engineers
- Lab Post Doc
- Medical Devices Manufacturers
- In Vitro Diagnostics (IVD) Researchers
- Quality Control (QC) Scientists
Applications Supported:
- Medical Devices
- In Vitro Diagnostics (IVD)
- In Vitro Cytotoxicity
- ISO 10993 Standard Series
- Sample Preparation
- Cubis® II High-Capacity Lab Balances
- Arium® Pro Ultrapure Lab Water Systems
- Picus® Electronic Pipettes
- Safetyspace® Filter Tips
- Claristep® Filtration System
- Sartorius Incucyte® Live-Cell Analysis System
- Extractables & Leachables (E&L)
- Chemical Characterization of Materials
Figure 1. Cover of Article.