Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

041

Date of Entry 04/04/2016

FR Recognition Number

8-406

Standard

ISO 5832-11 Second edition 2014-09-15
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy

Scope/Abstract

This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical implants.

NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with those specified in this part of ISO 5832.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

21 CFR 888.3XXX Metallic components of all implantables
21 CFR 872.4XXX Metallic components
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

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Andrew Steen

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6284

Andrew.Steen@fda.hhs.gov

John Goode

FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/

301-796-6407

john.goode@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization