- ISO 10993
- USP Class III & IV
Nelson Labs offers a full trifecta of services to meet the requirements of ISO 10993 for Extractables & Leachables, Biocompatibility and Toxicological Assessments of medical devices. Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with a unique set of testing requirements, the biocompatibility testing experience can be intimidating. Even after a device has been categorized, a myriad of decisions for each test remains.
Generally we recommend customers perform the following for new products:
- Biological Evaluation Plan (BEP)
- Product Tests – Biocompatibility (in vivo, in vitro) and Chemistry – Extractables & Leachables (E&L)
- Toxicological Assessment – Data summary and qualified safety assessment
The biocompatibility team at Nelson Labs will work with you to develop a comprehensive testing plan that’s right for your product. We will also partner with you throughout the testing process, helping you to eliminate time- and resource-draining surprises.
Our Technical Consulting group can provide a full service experience. If you are familiar with ISO 10993 and its requirements, you may also select services you need below.
Every medical device must be subjected to three common biocompatibility tests (often referred to as the Big Three): cytotoxicity, sensitization and irritation tests. Each test screens for the presence of toxic, leachable materials. Based on the category of the device, as many as five additional testing categories may be required (see test matrix).