Titanium remains one of the most appropriate metals for use in surgical implants, having a low likelihood of negative reaction. ISO 13179-1 provides you with guidance on using plasma-sprayed unalloyed titanium in these applications. Titled “Implants for surgery – Plasma-sprayed unalloyed titanium coatings on metallic surgical implants – Part 1: General requirements,” the standard has just been released.
The 12-page document is a primer on the topic. It is narrowly focused on unalloyed titanium coatings applied by plasma spraying in air and in vacuum. You’ll be provided with the requirements for the chemical composition of the titanium. Various ASTM standards are referenced for the powder used for plasma spraying, determining the iron content, and so on. Specific ISO standards are cited for biocompatibility, audit control, sampling, etc.
Details are provided for the information you’ll need to include in any test reports. There’s 15 requirements which set the floor for your reporting system. Additional information can also be included, at your discretion.
Eleven standards comprise the referenced documents (normative references) section of ISO 13179-1. And an additional nine make up the bibliography.
Even though this is the Part 1 of the series, there are no additional documents in the works for it. None-the-less, it is the tool you’ll want to use for the process of plasma-spraying titanium coatings on surgical implants and medical device components.
To purchase your copy of this new publication, head to the Document Center webstore at www.document-center.com. There you can search for and order the standards you need. Or consider getting in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com. We have been working with customers like you since 1982. Make us your Standards Experts!
