Recognized standard
7153-1 Second edition 1991-04-01
FDA recognition 8-344 · ISO · Materials
Key facts
| Recognition number | 8-344 |
|---|---|
| Designation | 7153-1 Second edition 1991-04-01 |
| Title | Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This part of ISO 7153 contains a survey and a selection of stainless steels available for use in the manufacture of surgical, dental and specific instruments for orthopaedic surgery. |
At a glance
- 10–99 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: