{"id":225,"date":"2026-08-24T00:00:00","date_gmt":"2026-08-23T16:00:00","guid":{"rendered":"https:\/\/hapresearch.com\/blog\/?p=225"},"modified":"2026-08-12T18:46:59","modified_gmt":"2026-08-12T10:46:59","slug":"meets-iso-13779-the-standard-says-it-does-not-apply-to-powder","status":"publish","type":"post","link":"https:\/\/hapresearch.com\/blog\/meets-iso-13779-the-standard-says-it-does-not-apply-to-powder\/","title":{"rendered":"\u201cMeets ISO 13779.\u201d The Standard Says It Does Not Apply to Powder."},"content":{"rendered":"<p>The certificate of analysis runs to a single page. Assay, appearance, loss on drying, heavy metals, a Ca\/P figure \u2014 and then, near the bottom, the line that ends most procurement conversations before they start: <em>conforms to ISO 13779<\/em>.<\/p>\n<p>It is a reassuring line. ISO 13779 is the international standard for hydroxyapatite in surgical implants, and a supplier willing to name it is a supplier submitting to an external rule. So the sensible next step is the one almost nobody takes: open the standard and read the first clause.<\/p>\n<h2>Clause 1<\/h2>\n<p>ISO 13779-1:2008, <em>Implants for surgery \u2014 Hydroxyapatite \u2014 Part 1: Ceramic hydroxyapatite<\/em>, opens its scope like this: \u201cThis part of ISO 13779 applies to hydroxyapatite blocks.\u201d<\/p>\n<p>Then it says what it does not apply to: \u201chydroxyapatite coatings, hydroxyapatite powder or nanoparticle-type and calcium phosphate ceramics which are not mainly composed of crystalline hydroxyapatite.\u201d In case the point is missed, a separate sentence repeats it: \u201cThis part of ISO 13779 does not apply to nanoparticle-type materials.\u201d<\/p>\n<p>Powder is excluded by name. Nanoparticles are excluded twice.<\/p>\n<p>None of which makes the supplier dishonest. Part 2 of the standard covers thermally sprayed coatings, Part 3 covers the chemical analysis and characterisation methods, Part 4 covers coating adhesion. A powder house may well run its material against the Part 3 methods and get good numbers. But \u201cconforms to ISO 13779\u201d on a powder certificate is a claim against a document whose own scope clause excludes the product it is printed on.<\/p>\n<h2>What the standard actually demands<\/h2>\n<p>Here is the part that reframes the whole exercise. Suppose the standard did apply. What would passing it prove?<\/p>\n<p>Clause 4.3 sets the crystalline phase composition: \u201chydroxyapatite shall be 50 % mass fraction or greater\u201d, while \u03b1-tricalcium phosphate, \u03b2-tricalcium phosphate, tetracalcium phosphate and calcium oxide \u201cshall each be equal to or less than 5 % mass fraction.\u201d The definition backs this up \u2014 \u201cceramic hydroxyapatite\u201d is defined in the standard as material containing \u201cmore than 50 % mass fraction of crystalline hydroxyapatite.\u201d<\/p>\n<p>Fifty per cent. A material can be half something else and still be ceramic hydroxyapatite under ISO 13779-1.<\/p>\n<p>The remaining requirements are tighter and more useful. The calcium-to-phosphorus atomic ratio must fall between 1.65 and 1.82. The hydroxyapatite phase must show a crystallinity value not less than 95 % of the fully crystalline reference. And Table 1 sets hard trace-element ceilings in mg\/kg: arsenic 3, cadmium 5, mercury 5, lead 30 \u2014 with a further rule that \u201cthe maximum allowable limit for metals having adverse biological reactions shall be a total of 50 mg\/kg.\u201d<\/p>\n<p>Those are the numbers worth having on a certificate. They are also the numbers most powder certificates summarise into two words: <em>heavy metals<\/em>, followed by a single pooled figure that tells you nothing about which metal.<\/p>\n<h2>The question that replaces the line<\/h2>\n<p>So the reassuring line turns out to be the least informative thing on the page \u2014 a standard cited for its authority rather than its content, against a product it excludes, with a purity floor of 50 % that no one intends you to notice.<\/p>\n<p>The replacement is not a longer certificate. It is four specific asks: the four trace elements reported individually against those ceilings, the Ca\/P ratio as a measured number, the crystallinity value, and the phase breakdown with each secondary phase named and quantified. A supplier who can produce those every lot is telling you what their process does. A supplier who answers with a standard\u2019s name is telling you what their marketing does.<\/p>\n<h2>Sources<\/h2>\n<p>ISO 13779-1:2008(E), <em>Implants for surgery \u2014 Hydroxyapatite \u2014 Part 1: Ceramic hydroxyapatite<\/em>, second edition 2008-10-01, ISO\/TC 150\/SC 1 \u2014 scope (clause 1), definitions (3.1), and requirements (4.1\u20134.4, Table 1). Standard catalogue entry: <a href=\"https:\/\/www.iso.org\/standard\/43826.html\">iso.org\/standard\/43826.html<\/a>. The related parts are ISO 13779-2 (thermally sprayed coatings), ISO 13779-3 (chemical analysis and characterisation of crystallinity ratio and phase purity) and ISO 13779-4 (coating adhesion strength). ASTM F1185, <em>Standard Specification for Composition of Hydroxylapatite for Surgical Implants<\/em>, is listed in the standard\u2019s own bibliography.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A certificate of analysis arrives for a hydroxyapatite powder, and near the bottom sits the line that closes the deal: conforms to ISO 13779. Clause 1 of that standard says something the certificate does not.<\/p>\n","protected":false},"author":1,"featured_media":234,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_yoast_wpseo_meta-robots-noindex":"","_yoast_wpseo_meta-robots-nofollow":"","_yoast_wpseo_bctitle":"","_yoast_wpseo_canonical":"","_yoast_wpseo_opengraph-title":"","_yoast_wpseo_opengraph-description":"","_yoast_wpseo_opengraph-image":"","_yoast_wpseo_opengraph-image-id":0,"_yoast_wpseo_twitter-title":"","_yoast_wpseo_twitter-description":"","_yoast_wpseo_twitter-image":"","_yoast_wpseo_twitter-image-id":0,"footnotes":""},"categories":[4],"tags":[59,60,41,46,61],"class_list":["post-225","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-research-science","tag-iso-13779","tag-medical-grade","tag-procurement","tag-specification","tag-trace-elements"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u201cMeets ISO 13779.\u201d The Standard Says It Does Not Apply to Powder. - HAP Research<\/title>\n<meta name=\"description\" content=\"ISO 13779-1 applies to hydroxyapatite blocks and excludes powder and nanoparticles by name. 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