ISO 5832-12 Second edition 2007-05-01

Standard Organization:

ISO 5832-12 Second edition 2007-05-01
Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy [Including: Technical Corrigedum 1 (2008)]

Recognition Date2014-01-30
Recognition List034
Recognition Number8-351
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Materials
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Rationale:

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

Scope:

This part of ISO 5832 covers the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire.

NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.

NOTE 2 The high carbon content of this alloy produces a structure containing a significant carbide distribution. This can be adjusted either in the production of the bar or in subsequent thermomechanical processing to produce the final device. Carbide distribution in the final device is not included as part of this document.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
Metallic components of all implantables
No product code information listed for §888.3XXX, Metallic components of all implantables
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
§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
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3645 Implant, Subperiosteal Class 2 ELE

FDA Guidance:

There is no relevant guidance developed at this time.

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