BS ISO 13779-6:2015
Current
The latest, up-to-date edition.
Implants for surgery. Hydroxyapatite Powders
Hardcopy , PDF
English
13-07-2018
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Manufacturing design requirement
6 Certificate of compliance
Annex A (informative) - Other possible characterization
tests
Bibliography
Describes requirements for hydroxyapatite powders used as a raw material for the manufacturing of surgical implants or coating of surgical implants.
| Committee |
CH/150/1
|
| DevelopmentNote |
Supersedes 14/30267655 DC. (01/2015)
|
| DocumentType |
Standard
|
| ISBN |
9780539017564
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO13779 specifies requirements for hydroxyapatite powders used as a raw material for the manufacturing of surgical implants or coating of surgical implants.
This part of ISO13779 does not apply to hydroxyapatite coatings, ceramic hydroxyapatite, glass ceramics, α- and β-tricalcium phosphate, or other forms of calcium phosphate.
| Standards | Relationship |
| ISO 13779-6:2015 | Identical |
| ISO 23145-1:2007 | Fine ceramics (advanced ceramics, advanced technical ceramics) — Determination of bulk density of ceramic powders — Part 1: Tap density |
| ISO 18549-2:2009 | Metallic powders — Determination of apparent density and flow rate at elevated temperatures — Part 2: Determination of flow rate at elevated temperatures |
| ASTM D 6393 : 2014 : REDLINE | Standard Test Method for Bulk Solids Characterization by Carr Indices |
| ISO 13779-1:2008 | Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite |
| ISO 5961:1994 | Water quality — Determination of cadmium by atomic absorption spectrometry |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 13779-3:2008 | Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity and phase purity |
| ISO 2591-1:1988 | Test sieving — Part 1: Methods using test sieves of woven wire cloth and perforated metal plate |
| ISO 8288:1986 | Water quality — Determination of cobalt, nickel, copper, zinc, cadmium and lead — Flame atomic absorption spectrometric methods |
| ISO 3953:2011 | Metallic powders — Determination of tap density |
| ISO 13779-2:2008 | Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite |
| ISO 13175-3:2012 | Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
| ISO 18757:2003 | Fine ceramics (advanced ceramics, advanced technical ceramics) — Determination of specific surface area of ceramic powders by gas adsorption using the BET method |
| ISO 4490:2014 | Metallic powders — Determination of flow rate by means of a calibrated funnel (Hall flowmeter) |
| ISO 787-11:1981 | General methods of test for pigments and extenders — Part 11: Determination of tamped volume and apparent density after tamping |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 24235:2007 | Fine ceramics (advanced ceramics, advanced technical ceramics) — Determination of particle size distribution of ceramic powders by laser diffraction method |
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