What is ISO 6474-1 about?
ISO 6474 discusses ceramic materials for surgical implants. ISO 6474-1 is an international standard that provides for ceramic materials based on high purity alumina for surgical implants.
ISO 6474-1 is the first part of a multi-part series that outlines the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements, and components of orthopedic joint prostheses.
Note: ISO 6474-1 does not cover biocompatibility. It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of ISO 6474-1 .
Who is ISO 6474-1 for?
ISO 6474-1 on ceramic materials based on high purity alumina for surgical implants is useful for:
Surgical implants manufacturers
Test centers for surgical implants
Regulatory authorities
Why should you use ISO 6474-1 ?
No known surgical implant material ha...
BS ISO 6474-1:2019 history
2019BS ISO 6474-1:2019 Implants for surgery. Ceramic materials. Ceramic materials based on high purity alumina
2010BS ISO 6474-1:2010 Implants for surgery - Ceramic materials - Ceramic materials based on high purity alumina
1997BS 7253-2:1997 Non-metallic materials for surgical implants - Specification for ceramic materials based on high purity alumina