ISO 5832-11 Second edition 2014-09-15

Standard Organization:

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

Recognition Date2016-04-04
Recognition List041
Recognition Number8-406
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 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.

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
Metallic components
No product code information listed for §872.4XXX, Metallic components
§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
§872.3890 Splint, Endodontic Stabilizing Class 2 ELS
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE

FDA Guidance:

There is no relevant guidance developed at this time.

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