Recognized standard
10993-17 First edition 2002-12-01 10993-17:2002/(R)2012
FDA recognition 2-237 · ISO · Biocompatibility
Key facts
| Recognition number | 2-237 |
|---|---|
| Designation | 10993-17 First edition 2002-12-01 10993-17:2002/(R)2012 |
| Title | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified… |
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: