| ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |
| Recognition Number | Materials |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 8-465 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Materials |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in this document.
| 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 |
| Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued June 2016. |