Recognized Consensus Standards

Recognition List Number: 018 Publication Date: 09/12/2007

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-67: ISO 7153-1:1991/Amd. 1:1999, Surgical instruments -- Metallic materials -- Part 1: Stainless steel. (Materials)

Date of Standard: 1999.

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), PMA, IDE, PDP, HDE, Design Controls

Type of Standard:

Horizontal, Material Specifications, International

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 document 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 fatigue 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
Unclassified	Accessories, Fixation, Spinal Intervertebral Body	Class U	LYQ
Unclassified	Guide, Drill, Ligament	Class U	LXI
§888.3050	Accessories, Fixation, Spinal Interlaminal	Class 2	LYP
§888.4540	Bone Mill	Class 1	LYS

Regulation Number	Device Name	Device Class	Product Code
§888.4300	Gauge, Depth	Class 1	HTJ

Regulation Number	Device Name	Device Class	Product Code
§888.4540	Applier, Cerclage	Class 1	HXN
§888.4540	Awl	Class 1	HWJ
§888.4540	Bender	Class 1	HXW
§888.4540	Bit, Drill	Class 1	HTW
§888.4540	Brace, Drill	Class 1	HXY
§888.4540	Broach	Class 1	HTQ
§888.4540	Burr, Orthopedic	Class 1	HTT
§888.4540	Corkscrew	Class 1	HWI
§888.4540	Countersink	Class 1	HWW
§888.4540	Crimper, Pin	Class 1	HXQ
§888.4540	Cutter, Wire	Class 1	HXZ
§888.4540	Driver, Prosthesis	Class 1	HWR
§888.4540	Extractor	Class 1	HWB
§888.4540	File	Class 1	HTP
§888.4540	Holder, Needle; Orthopedic	Class 1	HXK
§888.4540	Impactor	Class 1	HWA
§888.4540	Instrument, Bending Or Contouring	Class 1	HXP
§888.4540	Instrument, Compression	Class 1	HWN
§888.4540	Knife, Orthopedic	Class 1	HTS
§888.4540	Orthopedic Manual Surgical Instrument	Class 1	LXH
§888.4540	Passer	Class 1	HWQ
§888.4540	Passer, Wire, Orthopedic	Class 1	HXI
§888.4540	Positioner, Socket	Class 1	KIL
§888.4540	Probe	Class 1	HXB
§888.4540	Punch, Femoral Neck	Class 1	HWP
§888.4540	Pusher, Socket	Class 1	HXO
§888.4540	Reamer	Class 1	HTO
§888.4540	Rongeur	Class 1	HTX
§888.4540	Scissors, Orthopedic, Surgical	Class 1	HRR
§888.4540	Screwdriver	Class 1	HXX
§888.4540	Set, Hollow Mill	Class 1	HWL
§888.4540	Skid, Bone	Class 1	HWO
§888.4540	Staple Driver	Class 1	HXJ
§888.4540	Starter, Bone Screw	Class 1	HWD
§888.4540	Stripper, Surgical	Class 1	HRT
§888.4540	Tamp	Class 1	HXG
§888.4540	Tap, Bone	Class 1	HWX
§888.4540	Trephine	Class 1	HWK
§888.4540	Twister, Wire	Class 1	HXS
§888.4540	Wrench	Class 1	HXC

Regulation Number	Device Name	Device Class	Product Code
§888.4800	Template	Class 1	HWT