Recognized Consensus Standards

Recognition List Number: 025 Publication Date: 10/04/2010

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-194: ISO 6474-1 First edition 2010-02-15, Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina. (Materials)

Date of Standard: 2010.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Implantable Medical Devices

Processes Affected:

510(K), IDE, PMA, PDP, HDE, Design Controls

Type of Standard:

Material Standards, International, Horizontal

Extent of Recognition:

Complete Standard with additional comments outlined below:

This standard is a material specification for alumina ceramic stratified into either a type A or type B classification - ceramic materials of type A are intended for implants for high load applications (e.g. bearing surfaces of joint replacements); ceramic materials of type B are intended for implants for low load applications (e.g. maxillofacial and middle-ear implants).

Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data may be needed to document resistance to wear and abrasion. The wear behavior of implants is a system property and not only a material property. The wear test chosen should be conducted taking into consideration the intended use of the ceramic component. The test should refer to realistic application conditions of the articulating components.

Additional information must be provided to document the rationale for the selection, preparation, evaluation, and number of samples chosen for the microstructural analysis described in clause 5.3.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented	Class 3	LPF
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Class 3	MRA
§888.3353	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class 2	LZO