British Standards Institution

Source:: ISO
Committee:: CH/150/1 - Materials for surgical implants
Categories:: Implants for surgery, prosthetics and orthotics
Number of comments:: 0

Scope

<p>This document specifies the characteristics of, and corresponding test methods for bioinert ceramic material based on monolithic high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. The suitability of the material for other applications is not established within the framework of this document.</p> <p>This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.</p>

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Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

15/12/2025

3. Public Comments

Public Comments start date:

13/02/2026

Public Comments end date:

08/04/2026

Learn more about the standards development process

Standards Development

BS ISO 6474-1 Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina

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