Recognized standard
/TS 10993-20 First edition 2006-08-01 TIR 10993-20:2006
FDA recognition 2-240 · ISO · Biocompatibility
Key facts
| Recognition number | 2-240 |
|---|---|
| Designation | /TS 10993-20 First edition 2006-08-01 TIR 10993-20:2006 |
| Title | Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices. This part of ISO 10993 is based on several publications… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: