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BS ISO 13779-6:2015

BS ISO 13779-6:2015

Current

Current

The latest, up-to-date edition.

Implants for surgery. Hydroxyapatite Powders

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-13-2018

Publisher

British Standards Institution

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.

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.

Committee
CH/150/1
DevelopmentNote
Supersedes 14/30267655 DC. (01/2015)
DocumentType
Standard
ISBN
9780539017564
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

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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