ISO 13779-3:2018

Name: ISO 13779-3:2018 — Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity
SKU: ISO 13779-3:2018
Price: 57600 RUB
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Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity

Название (английский):

ISO 13779-3:2018

Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 32
Дата публикации:: 7 декабря 2018 г.
Издание:: ISO IS 13779 edition 2 version 1
ICS:: 11.040.40

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Срок поставки:6 раб. дн. (перевод)

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Описание (английский):

This document specifies methods of test for the chemical analysis, assessment of crystallinity ratio and phase composition of hydroxyapatite-based materials such as powders, coating or bulk products. NOTE These tests are intended to describe properties of the material and to communicate these between organizations. These tests are not written with the objective of replacing a company's internal operational and assessment tests although they could be used as such.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 13779-3:2018 - Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity - specifies standardized test methods to characterise hydroxyapatite (HA)‑based materials (powders, coatings, bulk products). The standard focuses on chemical composition, phase composition and the crystallinity ratio, enabling consistent communication of material properties between organizations without replacing internal operational tests.

Key topics and technical requirements

Scope and sample types: Methods apply to HA powders, coatings and bulk implant materials; includes guidance on sample preparation (e.g., scraping coatings to avoid substrate contamination).

Chemical analysis: Procedures, required apparatus and reagents, result expression and uncertainty reporting for elemental composition and contaminants (including heavy metals and CaO).

X‑ray diffraction (XRD): Detailed XRD procedures for phase identification and quantification, pattern collection, peak height/integrated intensity definitions, background handling and signal:noise considerations.

Crystallinity ratio: Defined as the ratio of summed integrated intensities of selected HA peaks in the sample to those after calcination at 1 000 °C for 15 h; two procedures (A and B) and an alternative method are provided with guidance on uncertainty.

Calibration and limits: Requirements for calibration specimens and calibration curves to convert integrated intensities into mass fractions of foreign phases; establishment of detection limit (DL) and quantification limit (QL) and associated uncertainty calculations.

Quantitative Phase Analysis (QPA): Rietveld refinement is introduced as an alternative quantitative method to determine foreign phase content from XRD data.

Reporting and traceability: Required test report elements and normative/informative annexes (reference material preparation, contamination notes, examples of XRD patterns, uncertainty calculations).

Practical applications and users

Who benefits:

Medical device manufacturers (orthopaedic, dental implants)

Quality control and analytical laboratories

Materials scientists and R&D teams developing HA coatings and bulk implants

Regulatory bodies and notified bodies assessing implant material data

Suppliers and contract manufacturers exchanging material specifications

Use cases:

Routine quality control of hydroxyapatite coatings and powders

Pre‑clinical material characterization for biocompatibility and resorption assessment

Supplier qualification and contract testing with reproducible phase‑purity metrics

Supporting regulatory submissions by documenting Ca:P ratio, foreign phase content and crystallinity measures

Related standards

ISO 13779 series (other parts cover physical properties, solubility, coatings)

ISO 3310-1 and ISO 3696 are referenced for sieving and laboratory water quality where applicable

Keywords: ISO 13779-3:2018, hydroxyapatite, implants for surgery, chemical analysis, crystallinity ratio, phase purity, X‑ray diffraction, Ca:P ratio, Rietveld, quantitative phase analysis.

ISO 13779-3:2018

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

BS ISO 13779-2:2018-TC

Tracked Changes. Implants for surgery. Hydroxyapatite. Thermally sprayed coatings of hydroxyapatite.

ISO 3310-1:2016

Test sieves — Technical requirements and testing — Part 1: Test sieves of metal wire cloth

ISO 3696:1987

Water for analytical laboratory use — Specification and test methods