Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

059

Date of Entry 12/19/2022

FR Recognition Number

8-595

Standard

ISO 5832-5 Fourth Edition 2022-03
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel

Scope/Abstract

This document specifies the characteristics of, and corresponding test methods for, wrought cobaltchromium-tungsten-nickel alloy for use in the manufacture of surgical implants.

NOTE The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

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)*

Regulation Number	Device Name	Device Class	Product Code
§872.3645	Implant, Subperiosteal	Class 2	ELE
§872.3940	Joint, Temporomandibular, Implant	Class 3	LZD
§872.3950	Glenoid Fossa Prosthesis	Class 3	MPI
§872.3960	Mandibular Condyle Prosthesis	Class 3	MPL
§872.4600	Lock, Wire, And Ligature, Intraoral	Class 2	DYX
§872.4760	Plate, Bone	Class 2	JEY
§872.4760	Implant, Transmandibular	Class 2	MDL
§872.4760	External Mandibular Fixator And/Or Distractor	Class 2	MQN
§872.4880	Screw, Fixation, Intraosseous	Class 2	DZL
21 CFR 888.3XXX Metallic components of all implantables

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

John Goode

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

301-796-6407

john.goode@fda.hhs.gov

Michael J. Ryan

FDA/OC/CDRH/OPEQ/ORP/

301-796-6283

michael.ryan@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization