BS ISO 6474-2:2019 Implants for surgery. Ceramic materials. Composite materials based on a high-purity alumina matrix with zirconia reinforcement

BS ISO 6474-2:2019

Implants for surgery. Ceramic materials. Composite materials based on a high-purity alumina matrix with zirconia reinforcement

Status : Current   Published : March 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies the characteristics of, and corresponding test methods for bio-stable ceramicbone-substitute material based on a zirconia-reinforced, high-purity alumina matrix composite for use as bone spacers, bone replacements and components in orthopaedic joint prostheses.

This document is intended for composite materials which are based on an alumina matrix, i.e. alumina as the dominating phase in the composite with a mass fraction of >60 %, similar to the material described in ISO 6474-1, but extended by means of a certain amount of zirconia and other defined ingredients.

NOTE The required properties in this document differ from those in ISO 6474-1 with respect to strength and fracture toughness. Furthermore, there are requirements specifically applicable for zirconia-containing materials (see ISO 13356).

In the material composition as defined in this document, additional additives are listed. Typical additives for alumina or zirconia ceramics are Mg, Y, Ce and others. Such additives can be useful in order to improve the mechanical properties and/or the chemical stability of the alumina-zirconia composite material.

This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is produced within the framework of this document.




Standard NumberBS ISO 6474-2:2019
TitleImplants for surgery. Ceramic materials. Composite materials based on a high-purity alumina matrix with zirconia reinforcement
StatusCurrent
Publication Date14 March 2019
Normative References(Required to achieve compliance to this standard)CEN/TS 14425-5, ASTM C1198, ISO 18754, ISO 22214, ISO 14243-1, ISO 14242-1, ISO 17561, ISO 15732, ASTM C1499, EN 623-2, ISO 13383-1, EN 843-2, EN 843-5, ISO 20501, EN 843-4, ASTM C1239, ASTM C1327, ISO 23146, ISO 13356, ISO 14704, EN 843-1, ISO 16428, ISO 14705, ISO 12677, EN 623-3, ASTM C1259, ASTM C1161, ASTM C1421, ASTM C1331, ISO 18756
Informative References(Provided for Information)ISO 6474-1, ISO 10993-1, ASTM E112
ReplacesBS ISO 6474-2:2012
International RelationshipsISO 6474-2:2019
Draft Superseded By17/30361518 DC
DescriptorsStrength of materials, Non-metals, Bend testing, Surgical equipment, Bulk density, Microscopic analysis, Grain size, Special ceramics, Wear tests, Chemical composition, Aluminium oxide, Ceramics, Test equipment, Wear resistance, Specimen preparation, Classification systems, Testing conditions, Implants (surgical), Prosthetic devices, Orthopaedics, Bones, Orthopaedic equipment, Compression testing, Bending, Crystal microstructure, Prosthesis
ICS11.040.40
Title in FrenchImplants chirurgicaux. Produits céramiques Matériaux composites à matrice alumine de haute pureté renforcée par des grains de zircone
CommitteeCH/150
ISBN978 0 580 98761 8
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size794 KB
Price£130.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


BSOL

The faster, easier way to work with standards


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version