What is ISO 13179-1 about?
ISO 13179-1 is one of a series of documents for coatings on metallic surgical implants that specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants.
Plasma-sprayed titanium as specified in ISO 13179-1 gives wear and corrosion resistance to the metallic surgical implants.
ISO 13179-1 applies to atmospheric plasma spraying and vacuum plasma spraying.
Note: ISO 13179-1 does not apply to coatings made of other materials than titanium or titanium-6 aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying.
Note 2: ISO 13179-1 covers the raw material, coating structures and properties and not finished medical devices, where the design and fabrication of the device can also impact biological response.
Who is ISO 13179-1 for?
ISO 13179-1 on coatings on metallic surgical implants is useful for-
- Manufacturers of implants for surgery
- Medical laboratories
- Companies producing plasma-sprayed coating
Why should you use ISO 13179-1?
Plasma spraying is a method of thermal spraying that produces coatings using a plasma jet on metallic surgical implants. While no known surgical implant material has ever been shown to be completely free of adverse reactions in the human body.
ISO 13179-1 guidelines will help you to meet general requirements, sampling, and procedures for coatings on metallic surgical implants which improves biocompatibility and prevents ion release from the metallic substrate which results in reduced mechanical failure and ensure patient’s health and safety.
While no known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. Material referred to in ISO 13179-1 has shown that an acceptable level of biological response can be expected if the material is used in appropriate applications.
Plasma spray coatings are applied to provide wear and corrosion protection, also give functional properties such as thermal insulation or biocompatibility to the surfaces on which it is sprayed.
What’s changed since the last update?
BS ISO 13179-1:2021 supersedes ISO 13179-1:2014, which has been withdrawn. BS ISO 13179-1:2021 has some technical changes with respect to ISO 13179-1:2014. These include:
- The title and scope of the document were changed to include coatings derived from titanium-6 aluminum-4 vanadium alloy powder
- Two new terms 3.2 and 3.3 were introduced to add a distinction between vacuum plasma spraying and atmospheric plasma spraying
- In 4.2.1, three separate tables were introduced to distinguish the chemical composition limits of different coating addressed by this document
- In 4.4.3, the term shear fatigue maximum strain was corrected to shear fatigue maximum stress