This specification covers the chemical, particle size, and cleanliness requirements for unalloyed titanium and titanium-6aluminum-4vanadium alloy powders for use as coatings, formed by sintering or thermal spraying techniques, onto titanium alloy surgical implants. The powders may be manufactured by the plasma rotating electrode, inert gas atomization, or hydride-dehydride process, or other method capable of producing powder meeting the requirements of this specification. This specification addresses only the powder requirements, and not the properties of the coatings formed from them.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
1.1 This specification covers the requirements for unalloyed titanium and Ti-6Al-4V alloy powders for use in fabricating coatings on titanium alloy implants.
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.
1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.
1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate guidelines.
1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
B214 Test Method for Sieve Analysis of Metal Powders
B215 Practices for Sampling Metal Powders
B299 Specification for Titanium Sponge
E11 Specification for Woven Wire Test Sieve Cloth and Test Sieves
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
ISO 9001 Quality Management System Requirements
Aerospace Material Specifications
AMS 4998 Powder, 6Al-4V
coatings; metallic; metals (for surgical implants titanium alloys); orthopaedic medical devices (titanium/titanium alloys); powder; porous coatings; titanium/titanium alloys (for surgical implants); Metallic coatings; Metallic surgical implant materials--specifications; Metal powders--specifications; Metals (for surgical implants)--titanium alloys; Orthopaedic medical devices--specifications (Ti/Ti alloy); Porous coatings--specifications; Powder coatings; Powders; Titanium (Ti) (for surgical implants)--specifications; Surgical implants--specifications
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 77.120.50 (Titanium and titanium alloys)
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