Biocompatibility Testing Resources
Here are some resources that can help you understand the requirements for biocompatibility testing that were used to form this website and other tools .
| Organization | Description |
|---|---|
| FDA_USA | The FDA is the Food and Drug Administration, a federal agency of the United States Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. They provided a document that contains the requirements for biocompatibility testing based on the ISO 10993-1:2018 documents in a way it is easier to understand. |
| TÜV SÜD | TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions. Over the last 150 years, they have added tangible value to their partners and customers through a comprehensive portfolio of testing, certification, auditing and advisory services. They provided a document that contains the requirements for biocompatibility testing based on the ISO 10993-1:2018 documents in a way it is easier to understand. |
| ISO 10993-1:2018 documents | ISO 10993-1:2018 specifies: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of medical devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyze the biological safety of the medical device; the assessment of the biological safety of the medical device. They provided a document that contains the requirements for biocompatibility testing based on the ISO 10993-1:2018 documents in a way it is easier to understand. |
Pacific Biolabs
Pacific Biolabs is a biocompatibility testing company that provides services for various industries.
They have a biocompatibility testing learning center that provides a lot of information about the tests and their requirements.
Visit the Pacific Biolabs website to learn more about their services.