Recognized standard
13175-3 First edition 2012-10-01
FDA recognition 8-457 · ISO · Materials
Key facts
| Recognition number | 8-457 |
|---|---|
| Designation | 13175-3 First edition 2012-10-01 |
| Title | Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 13175 specifies requirements for monophasic hydroxyapatite bone substitutes, monophasic β-tricalcium phosphate bone substitutes and biphasic hydroxyapatite/β-tricalcium phosphate bone substitutes in the form of blocks or granules. This part of ISO 13175 is not applicable to… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: