ISO 5832-3 Fourth edition 2016-10-15

Standard Organization:

ISO 5832-3 Fourth edition 2016-10-15
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

Recognition Date2017-08-21
Recognition List047
Recognition Number8-447
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 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture of surgical implants.

NOTE The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given 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
§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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