BS ISO 13779-2:2018 Implants for surgery. Hydroxyapatite. Thermally sprayed coatings of hydroxyapatite

BS ISO 13779-2:2018

Implants for surgery. Hydroxyapatite. Thermally sprayed coatings of hydroxyapatite

Status : Current   Published : December 2018



What is this standard about?

This document specifies requirements for single layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants.

These requirements are intended to describe properties of the materials and to communicate these between organizations. These requirements are not written with the objective of replacing a company’s internal operational and assessment requirements although they could be used as such.

NOTE 1 For thin coatings with a thickness of less than 50 µm, some of the test methods described in this document might be difficult to apply without modification.

NOTE 2 The requirements of the hydroxyapatite layer of dual-layer coatings (consisting of a lower layer of metallic coating and an upper layer of hydroxyapatite coating) can follow this document; however, testing methods referred to in this document cannot be applied to dual layer coatings. If this document is taken in reference for the requirements of the hydroxyapatite layer of dual layer coatings, a rationale on how the singlelayer tested coupons are representative of the dual-layer coated implant might be considered necessary. This document does not cover coatings made from glasses, glass ceramics, alpha- and beta-tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate.

NOTE 3 While the requirements in this document are intended to be used as specifications of a thermally sprayed coating of hydroxyapatite, it might be necessary to establish routine control procedures specifying control tests and their time intervals to make sure the characteristics of the coating stay within specified limits.

NOTE 4 This document was developed with a focus on plasma sprayed coating of hydroxyapatite. It might also be used to characterize other thermally sprayed coatings of hydroxyapatite. However, thermally sprayed coatings that do not have a history of clinical use might present different risks and might need additional characterizations beyond those identified in this document.

Standard NumberBS ISO 13779-2:2018
TitleImplants for surgery. Hydroxyapatite. Thermally sprayed coatings of hydroxyapatite
Publication Date07 December 2018
Normative References(Required to achieve compliance to this standard)ISO 13779-4, ASTM F1854, ISO 13779-6, ISO 4288, ASTM F1044, ISO 13779-3, ISO 10993-1
Informative References(Provided for Information)ASTM F1926, ASTM F1160 - 14
ReplacesBS ISO 13779-2:2008
International RelationshipsISO 13779-2:2018
Draft Superseded By17/30302767 DC
DescriptorsCoatings, Surgical equipment, Chemical composition, Orthopaedic equipment, Calcium inorganic compounds, Special ceramics, Orthopaedics, Implants (surgical), Non-metallic coatings, Surgery, Ceramics, Hydroxides
Title in FrenchImplants chirurgicaux. Hydroxyapatite Revêtements à base d'hydroxyapatite, obtenus par projection thermique
ISBN978 0 580 86938 9
File Size903 KB

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