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ASTM F2066-23

Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

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NORMA vydána dne 1.4.2023

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Informace o normě:

Označení normy: ASTM F2066-23
Datum vydání normy: 1.4.2023
Kód zboží: NS-1138656
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Kategorie - podobné normy:

Chirurgické nástroje a materiály

Anotace textu normy ASTM F2066-23 :

This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; bar; or wire. The heat analysis shall conform to the chemical composition prescribed. Material shall be furnished in the beta annealed condition. Bend tests and tension tests shall be performed to conform to the specified requirements.

Keywords:
metals (for surgical implants), orthopaedic medical devices, titanium alloys, titanium alloys (for surgical implants),, ICS Number Code 11.040.30 (Surgical instruments and materials)

Doplňující informace

1. Scope

1.1?This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).2

1.2?The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of each other, and values from the two systems shall not be combined.

1.3?This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

E1409-13(2021)	Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
E539-19	Standard Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
E290-22	Standard Test Methods for Bend Testing of Material for Ductility
E112-13(2021)	Standard Test Methods for Determining Average Grain Size
E29-22	Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E8/E8M-24	Standard Test Methods for Tension Testing of Metallic Materials
E1447-22	Standard Test Method for Determination of Hydrogen in Reactive Metals and Reactive Metal Alloys by Inert Gas Fusion with Detection by Thermal Conductivity or Infrared Spectrometry
IEEE/ASTM SI 10	American National Standard for Use of the International System of Units (SI): The Modern Metric System
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F1408-20a	Standard Practice for Subcutaneous Screening Test for Implant Materials (Includes all amendments and changes 9/1/2020).
E1941-10(2016)	Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E2371-21a	Standard Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma Atomic Emission Spectrometry (Performance-Based Test Methodology) (Includes all amendments and changes 1/6/2022).
F67-13(2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

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