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  • BSI
    BS ISO 13779-2:2018 Implants for surgery. Hydroxyapatite - Thermally sprayed coatings of hydroxyapatite
    Edition: 2018
    $313.97
    / user per year

Description of BS ISO 13779-2:2018 2018

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 single-layer 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
StatusUnder Review
Publication Date2018-12-07
ReplacesBS ISO 13779-2:2008
Identical National Standard OfISO 13779-2:2018
DescriptorsHydroxides, Ceramics, Surgery, Non-metallic coatings, Implants (surgical), Orthopaedics, Special ceramics, Calcium inorganic compounds, Orthopaedic equipment, Chemical composition, Surgical equipment, Coatings
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/1
ISBN978 0 580 86938 9
PublisherBSI
Pages20

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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