Recognized standard
10993-7 Second edition 2008-10-15
FDA recognition 2-275 · ISO · Biocompatibility
Key facts
| Recognition number | 2-275 |
|---|---|
| Designation | 10993-7 Second edition 2008-10-15 |
| Title | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background… |
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: