Recognized Consensus Standards

Recognition List Number: 020 Publication Date: 09/09/2008

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-58: ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. (Materials)

Date of Standard: 1996.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF DEVICE EVALUATION (ODE)

(2)	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Metallic Implants

Processes Affected:

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

Type of Standard:

International, Horizontal

Extent of Recognition:

This standard includes requirements for chemical composition, metallurgical characteristics, and mechanical properties in various conditions. Although this material has a long history of successful use for implants, the standard has no specific requirements regarding biologic response. Refer to the appropriate biocompatibility standards for specific biocompatibility requirements. Additional information must be provided to documenet that the design of the product will provide adequate mechanical properties for the particular application. Depending on the device application, additional material property data (such as fatgue life, wear and abrasion resistance, pitting or crevice corrosion resistance, and magnetic susceptibility) may be required beyond what is addressed by this standard.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§872.3640	Implant, Endosseous, Root-Form	Class 2	DZE

Regulation Number	Device Name	Device Class	Product Code
§872.3645	Implant, Subperiosteal	Class 2	ELE

Regulation Number	Device Name	Device Class	Product Code
§872.3890	Splint, Endodontic Stabilizing	Class 2	ELS

Regulation Number	Device Name	Device Class	Product Code
§872.3940	Joint, Temporomandibular, Implant	Class 3	LZD

Regulation Number	Device Name	Device Class	Product Code
§872.3950	Glenoid Fossa Prosthesis	Class 3	MPI

Regulation Number	Device Name	Device Class	Product Code
§872.3960	Mandibular Condyle Prosthesis	Class 3	MPL

Regulation Number	Device Name	Device Class	Product Code
§872.4600	Lock, Wire, And Ligature, Intraoral	Class 2	DYX

Regulation Number	Device Name	Device Class	Product Code
§872.4760	External Mandibular Fixator And/Or Distractor	Class 2	MQN
§872.4760	Implant, Transmandibular	Class 2	MDL
§872.4760	Plate, Bone	Class 2	JEY

Regulation Number	Device Name	Device Class	Product Code
§872.4880	Screw, Fixation, Intraosseous	Class 2	DZL

No Product Code information listed for §888.3XXX, Metallic components of all implantables