Recognized standard
E1262-88 (Reapproved 2018)
FDA recognition 2-136 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-136 |
|---|---|
| Designation | E1262-88 (Reapproved 2018) |
| Title | Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | 1.1 This guide highlights some of the more relevant biological concepts as they are currently understood, and summarizes the critical technical aspects for acceptable bioassay performances as they currently are perceived and practiced. The Chinese hamster ovary cell/hypoxanthine guanine… |
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: