F04.12 - Metallurgical Materials

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants, and may be furnished as descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or cold drawn. The alloy shall be multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals. Heat analysis shall conform to the chemical composition requirements prescribed for aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and titanium. The material shall conform to the specified requirements for mechanical properties such as ultimate tensile strength, yield strength, and elongation. A minimum of two tension tests from each lot shall be performed. Special requirements for the microstructure are detailed as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants (1-7).2  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.

ABSTRACT
This specification covers UNS S31673 chromium-nickel-molybdenum wrought annealed stainless steel surgical fixation wires. The wires should conform to the required values of tensile strength and elongation. Wire surfaces should be processed to minimize tool marks, nicks, scratches, cracks, cavities, spurs, and other imperfections that would impair wire serviceability.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought 18chromium-14nickel-2.5molybdenum stainless steel in the form of surgical fixation wire.  
1.2 Units—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 the 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.

ABSTRACT
This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms are addressed. This specification applies to straight length tubing of specified diameters and thickness. Seamless tubing shall be made from bar, hollow bar, rod, or hollow rod raw material forms through a prescribed process. Welded and drawn tubing shall be made from strip or sheet raw material forms that meet the specified chemical requirements. The tubing shall be subject to tensile testing.
SCOPE
1.1 This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F90, F562, F688, F1058 or F1537, Alloy 1. This specification addresses those product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms covered in these specifications.  
1.2 This specification applies to straight length tubing with 6.3 mm [0.250 in.] and smaller nominal outside diameter (OD) and 0.76 mm [0.030 in.] and thinner nominal wall thickness.  
1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification.  
1.4 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 the other, and values from the two systems shall not be combined.  
1.5 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.  
1.6 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.

ABSTRACT
This specification covers the chemical requirements for wrought stainless steels used for the manufacture of surgical instruments. Classes of stainless steels covered here are Class 3 (austenitic stainless steel), Class 4 (martensitic stainless steel), Class 5 (precipitation hardening stainless steel), and Class 6 (ferritic stainless steel). The data contained in this specification, such as typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, are provided for reference only. Mechanical property, heat treatment, hardness, and all other requirements except for chemical composition, are governed by the appropriate material standards as specified or as agreed upon between purchaser and supplier.
SCOPE
1.1 This specification covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical instruments. The data contained in Tables 1-4 of this specification, including typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, is provided for reference only. Mechanical property requirements, heat treating requirements, hardness requirements, and all other requirements except chemistry are governed by the appropriate material standards as referenced below or as agreed upon between the purchaser and supplier.      
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of each other. Combining values from the two systems may result in nonconformance with the standard.  
1.3 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.

SIGNIFICANCE AND USE
3.1 This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on metallic surgical implants.
SCOPE
1.1 This practice is intended as a standard for fluorescent penetrant inspection of metallic surgical implants.  
1.2 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.  
1.3 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.

ABSTRACT
This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants  
1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.

ABSTRACT
This specification covers the requirements for unfinished cobalt-28chromium-6molybdenum (UNS R30075) investment product alloy castings for surgical implant applications, and casting alloys of the same in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings. Both product castings and casting alloys shall conform to specified chemical composition and mechanical requirements including ultimate tensile strength, yield strength, elongation, and reduction of area. Product castings shall additional undergo liquid penetrant, radiographic, metallographic, and hardness examination.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for cobalt-28 chromium-6 molybdenum alloy unfinished investment product castings for surgical implant applications and casting alloy in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.

ABSTRACT
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.
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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy bars, rods, wires, sheets, and strips (except surgical fixation wires) for use in surgical implants. All alloys shall be furnished to the purchaser's specifications, in the annealed or cold-worked condition. Then, bars and wires shall be finished bright annealed, cold drawn, pickled, ground, or ground and polished, as specified by the purchaser. While, sheets shall be furnished bright annealed, pickled, cold-rolled, or polished, as specified by the purchaser. The alloys shall adhere to specified values of ultimate tensile strength, yield strength, elongation, and microcleanliness.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy used for surgical implants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixation wire (see Specification F1091).  
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 may not be exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the 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.

SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for two types of metal injection molded (MIM) titanium-6aluminum-4vanadium components to be used in the manufacture of surgical implants.  
1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post sinter processing.  
1.3 Units—The values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independent of the other. Combining values from the two systems may result in nonconformance with the specification.  
1.4 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.  
1.5 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.

ABSTRACT
This specification covers the requirements for wrought titanium-6aluminum-4vanadium alloy for use in surgical implant applications. The material shall be manufactured by multiple melting in plasma arc and electron beam furnaces into strip, sheet, plate, bar, forging bar, or wire. The material shall be available in the annealed or cold-worked condition, with the surface mechanically descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or a combination of these. Heat and product analyses as well as tension and bend (for sheet, strip, and plate) tests shall be performed and shall conform to the requirements specified. In addition, the material shall have a microstructure consisting of a fine dispersion of alpha and beta phases as a result of processing in the alpha plus beta field, with no continuous alpha network at prior beta grain boundaries and no coarse, elongated alpha platelets.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium alloy (UNS R56400) to be used in the manufacture of surgical implants.  
1.2 Units—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 the other, and values from the two systems shall not be combined.  
1.3 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.

ABSTRACT
This specification covers the requirements for wrought seamless or welded and drawn 18chromium-14nickel-2.5molybdenum stainless steel small diameter tubing for surgical implants. Manufacturing method shall be seamless or welded and drawn process. Tubing shall conform to chemical composition, dimensions, and mechanical properties of this specification. Mechanical properties include ultimate tensile strength, yield strength, and elongation. Outside and inside diameter, wall thickness, length and straightness shall conform to the permissible limits of this specification.
SCOPE
1.1 This specification covers the requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specification F138 (for seamless) or Specification F139 (for welded and drawn). This specification addresses those product variables that differentiate small-diameter medical grade tubing from the bar, wire, sheet, and strip product forms covered in these specifications.  
1.2 This specification applies to cold finished straight length tubing with 3 mm [0.125 in.] and smaller nominal outside diameter (OD) and 0.5 mm [0.020 in.] and thinner nominal wall thickness.  
1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. Inch-pound units are shown in brackets. 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 the other and values from the two systems shall not be combined.  
1.5 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.  
1.6 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.

SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip, bar, and wire used in the manufacture of surgical implants.  
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other and values from the two systems shall not be combined.  
1.3 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.

ABSTRACT
This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work-strengthening, and work-strengthening and aging to attain a variety of combinations of strength and ductility. Materials shall be tested and the individual grades shall conform to chemical requirements such as chemical composition and their tolerances, and mechanical properties such as tensile strength, yield strength, elongation, and area reduction.
SCOPE
1.1 This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work strengthening and aging to attain a variety of combinations of strength and ductility.  
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 may not be exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. The mill product shall be furnished as descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished. Conditions for annealing, cold-working and stress relieving, and surface cleanliness are specified. Heat analysis shall conform to the chemical composition requirements prescribed for: nitrogen, carbon, hydrogen, iron, oxygen, aluminum, vanadium, yttrium, and titanium. The material shall conform to the mechanical property requirements specified for: ultimate tensile strength, yield strength, and elongation. Requirements for tension testing, microstructure, ultrasonic testing, and longitudinal and transverse notch machining are specified as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. See Section 4 for size limitations.  
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 may not be exact equivalents; therefore, each system shall be used independently of the 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-13niobium-13zirconium alloy (UNS R58130) bars and wires to be used in the manufacture of surgical implants. The mill products may be supplied as specified by the purchaser with a descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished finish. Materials shall be furnished in the unannealed, solution-treated, or capability-aged condition. The mechanical properties to which the alloys shall conform are tensile strength, yield strength, elongation, and reduction of area.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-13niobium-13zirconium alloy to be used in the manufacture of surgical implants  (1).2  
1.2 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.  
1.3 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.

ABSTRACT
This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for coating of orthopedic implants. This specification covers powder requirements only and does not address coating properties. Materials may be manufactured by rotating electrode process, inert gas atomization, or other methods that meet the powder requirements of this specification. The powder shall conform to chemical composition, sieve analysis, and cleanliness requirements of this specification.
SCOPE
1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating cobalt-28chromium-6molybdenum alloy medical devices.  
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques, or in metal injection molding or additive manufacturing.  
1.3 This specification covers powder requirements only. It does not address properties of the coatings or components formed from them.  
1.4 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 the other, and values from the two systems shall not be combined.  
1.5 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.  
1.6 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.

ABSTRACT
This specification establishes the chemical, mechanical, and metallurgical requirements for wrought molybdenum-47.5 rhenium alloy to be used in the manufacture of surgical implants. The alloy consists of nominal 47.5 mass percent rhenium balance molybdenum of approximately 99.79% purity and residual plus trace elements. This specification applies to round bars and flats from 1.00 mm (0.0394 in.) to 101.60 mm (4.00 in.) in diameter or thickness (other sizes and shapes by special order), any sheet under 4.76 mm (0.1875 in.) in thickness and 610 mm (24 in.) or more in width, and other forms and shapes as may be agreed upon by the purchaser and supplier. The product may be furnished to the implant manufacturer as mechanically or chemically descaled by pickling, abrasively blasting, chemically milled, ground, machined, peeled, polished, combinations of these operations, or as specified by the purchaser. On billets, bars, plates, and forgings, minor surface imperfections may be removed by grinding or machining if the resultant area meets the dimensional and surface finish requirements of this specification.
Also covered by this specification are ordering information, ultrasonic inspection, significance of numerical limits, certification, and quality program requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought molybdenum-47.5 rhenium alloy to be used in the manufacture of surgical implants.  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants.  
1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independent of the other. Combining values from the two systems may result in nonconformance with the specification.  
1.4 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.  
1.5 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.

ABSTRACT
This specification establishes the chemical, physical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-2.5vanadium alloy (R56320) to be used in the manufacture of surgical implants. It covers various titanium mill products that are normally formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants. The alloy is usually multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-3aluminum-2.5vanadium alloy (R56320) to be used in the manufacture of surgical implants.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values of the two systems may result in nonconformance within the standard.  
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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for cast titanium-6aluminum-4vanadium alloy (UNS R56406). Castings conforming to this specification shall be produced by vacuum investment casting. Castings covered by this specification shall be in the annealed and hot isostatically pressed condition. Product castings shall conform to the requirements prescribed. Material supplied under this specification shall conform to the mechanical property requirements prescribed. Chemical analysis, product analysis, tension tests, fluorescent penetrant examination, and radiographic examination shall be performed to meet the specified requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for cast titanium-6aluminum-4vanadium alloy (UNS R56406).  
1.2 Units—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 the 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.

ABSTRACT
This specification covers the chemical composition, mechanical, and metallurgical requirements for wrought nitrogen strengthened 21chromium-10nickel-3manganese-2.5molybdenum stainless steel alloy bars for use in surgical implants. The alloy bars shall be furnished in the annealed, medium hard, or hard condition, and shall be finished cold-drawn, pickled, ground, ground and polished, or as specified by the purchaser.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 21chromium-10nickel-3manganese-2.5molybdenum stainless steel alloy bar for surgical implants.  
1.2 The values stated in either inch-pound units or SI units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.3 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12 molybdenum- 6 zirconium-2 iron alloy for surgical implants to be used in the manufacture of surgical implants. The heat analysis shall conform to the chemical composition requirements prescribed. Ingot analysis may be used for reporting all chemical requirements, except hydrogen. The wrought titanium-12 molybdenum-6 zirconium-2 iron alloy are classified as bar, forging bar and wire. The ultimate tensile strength, yield strength, elongation, and area reduction of the material shall be tested to meet the requirements prescribed.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12molybdenum-6zirconium-2iron alloy mill products to be used in the manufacture of surgical implants.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 the other, and values from the two systems shall not be combined.  
1.3 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.

SIGNIFICANCE AND USE
3.1 The objective of surface treatments as documented in this practice is to improve the corrosion resistance of metallic surgical implants including, but not limited to, those manufactured from iron, cobalt, nickel, titanium, and tantalum base materials.  
3.2 Iron particles, ceramic media, and other foreign particles may become smeared over or embedded into the surface of implants during processing operations such as forming, machining, tumbling, media blasting, marking, and so forth. These particles should be removed to minimize localized corrosion and superficial blemishes.  
3.3 The various chemical and electrochemical surface treatments specified by this practice are used to remove objectionable surface contaminants and to restore maximum corrosion resistance to, or promote the creation of, an inert or passive surface, such as a metal oxide film, as is applicable to the specific material. Some of these treatments are referred to as passivation treatments. The preferred surface treatment for a given application varies depending on the implant material and the nature of the surface contaminants.  
3.4 Depending on the implant, its material, and the type of marking method and procedure, the marking may be applied before or after a chemical or electrochemical surface treatment. When marking is performed after the surface treatment, the localized implant surface shall be evaluated to determine if there is a need for additional surface treatment.
Note 1: The need for additional surface treatment is likely for stainless steel with all marking methods, and for nonferrous alloys when the marking method involves direct or second-hand contact with iron-based or other material that would be considered an objectionable surface contaminant.  
3.5 The selection of procedures to be applied to the implants, and additional requirements which are not covered by this practice, may be included in the implant production specification.
SCOPE
1.1 This practice provides descriptions of surface characteristics, surface preparation, and marking for metallic surgical implants, with the purpose of improving the corrosion resistance of the implant surfaces and markings.  
1.2 Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.4).  
1.3 Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.5 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.  
1.6 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.

SCOPE
1.1 This terminology is a compilation of definitions of terms used in ASTM documents relating to nickel-titanium shape memory alloys used for medical devices. This terminology includes only those terms for which ASTM either has standards or which are used in ASTM standards for nickel-titanium shape memory alloys. It is not intended to be an all-inclusive list of terms related to shape memory alloys.  
1.2 Definitions that are similar to those published by another standards body are identified with abbreviations of the name of that organization; for example, ICTAC is the International Confederation for Thermal Analysis and Calorimetry.  
1.3 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.

SIGNIFICANCE AND USE
5.1 The metallurgical properties of materials used to manufacture absorbable metallic implants can influence biological reactions and mechanical interaction with soft and hard tissue in the body. This standard guide describes a suggested material characterization scheme for absorbable metallic materials to ensure reproducibility of properties prior to their manufacture into medical implants.
SCOPE
1.1 This guidance document provides metallurgical characterization information that may be beneficial in the evaluation of absorbable metallic materials intended for medical implant applications. This guide is primarily intended for absorbable metallic materials that undergo further processing into a fabricated final device. Therefore, this standard does not require assessments that are more appropriately conducted on the final device, such as biological evaluation. However, a few relevant standards for finished implant devices are included for information purposes.  
1.2 The purpose of this guide is to identify appropriate test methods and relevant medical product standards that can be used to develop future standards for new or modified absorbable metallic materials.  
1.3 This guide is not intended to cover other major classes of absorbable materials such as polymers, ceramics, composites, and tissue-engineered materials.  
1.4 This standard guide is focused on the chemical, physical, microstructural, and mechanical properties plus inspection guidelines for metallic materials that are used for medical implants designed to be absorbed in the body over a period of time. This guide focuses on material characterizations and does not address device specific mechanical testing that may be necessary to determine safety and functionality of the implant.  
1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required.  
1.6 Since surface modifications of medical implants are generally applied in the latter stages of manufacturing, this standard guide does not cover the characterization of either absorbable or non-absorbable surface coatings that are metallic in origin such as oxides or from the addition of other materials such as ceramics or polymers. However, this standard does apply to absorbable metallic materials, regardless of the presence or absence of a coating.  
1.7 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.  
1.8 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought, nitrogen strengthened manganese-chromium-molybdenum low-nickel stainless steel alloy bars and wires used for surgical implants. All bars and wires should be furnished as specified in either annealed or cold-worked condition and in cold-drawn, pickled, ground and polished, ground, or any other specified finish. The products should conform to the required chemical composition, microcleanliness, purity, surface finish, tensile properties, and hardness and should pass the intergranular corrosion susceptibility test. Both wires and bars must have a homogenous microstructure and with grain sizes within the specified range.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 23manganese-21chromium-1molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.  
1.2 Units—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 the 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.

ABSTRACT
This specification covers the requirements for three compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Materials shall be tested and shall conform to chemical composition, metallurgical requirements, and mechanical properties. Materials and manufacture are also detailed.
SCOPE
1.1 This specification covers the requirements for five compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specification F138, F1314, F1586, F2229, or F2581. This specification addresses those product variables that differentiate wrought seamless tubing from the bar and wire product forms covered in these specifications.  
1.2 This specification applies to cold finished, straight length tubing from 3 to 34 mm [0.125 to 1.315 in.] nominal outside diameter (OD) and 0.5 mm [0.020 in.] and greater nominal wall thickness.  
1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. Inch-pound units are shown in brackets. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other and values from the two systems shall not be combined.  
1.5 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.  
1.6 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for three wrought cobalt-28chromium-6molybdenum alloys used for surgical implants. The properties specified apply specifically to wrought bar, rod, and wire. The alloys shall conform to the prescribed chemical requirements. Two tension and two bend tests shall be performed on each sample lot to determine tensile properties. Bar, rod, and wire conforming to this specification shall have a homogeneous microstructure with an average grain size of ASTM No. 5 or finer when measured.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three wrought cobalt-28chromium-6molybdenum alloys used for surgical implants. The properties specified apply specifically to wrought bar, rod, and wire.  
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 the other, and values from the two systems shall not be combined.  
1.3 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.

SIGNIFICANCE AND USE
4.1 The requirements in this practice are intended to control the quality of the radiographic image of cast metallic surgical implants and related weldments.
SCOPE
1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments.  
1.2 Units—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 the 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.

ABSTRACT
This specification covers alpha plus beta titanium alloy forgings for use in surgical implants such as orthopaedic medical devices. The products should be forged by hammering, pressing, extruding, or upsetting bars or wires and should be free of splits, scales, cracks, flaws, and other imperfections. After hot forging, each product should be subjected to annealing treatment consisting of heating the parts to an appropriate temperature and followed by cooling. Samples should be tested according to the specified procedure and should conform to the required values for chemical composition, tensile strength, hardness, elongation, and area reduction.
SCOPE
1.1 This specification covers the requirements for titanium alloy forgings for surgical implants, in the alpha plus beta condition, when the material forged conforms to Specifications F136 (UNS R56401), F1295 (UNS R56700), F1472 (UNS R56400), or F2066 (UNS R58150).  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.

ABSTRACT
This specification covers the chemical composition and mechanical requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) forgings for use in surgical implants. The material covered here shall be in the form of bars, plates, sheets, or wires manufactured in the solution-annealed condition with a finish suitable for forging by hammering, pressing, rolling, extruding, or upsetting.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of forgings, used for the manufacture of surgical implants.  
1.2 Units—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 the 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.

SIGNIFICANCE AND USE
4.1 The requirements expressed in this practice are intended to control the quality of the digital radiographic image of cast metallic surgical implants.
SCOPE
1.1 This practice covers the procedure for digital radiographic testing of cast metallic surgical implants and related weldments.  
1.2 Digital X-ray is an alternative method for radiography of cast metallic surgical implants and related weldments (see Practice F629).  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.4 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.  
1.5 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.

ABSTRACT
This specification covers the requirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel surgical fixation wire. The starting material, dimensions, and tolerances shall conform to the requirements specified. The surgical fixation wire is usually furnished in the bright-annealed condition. Mechanical properties of the surgical fixation wire such as tensile strength and elongation shall be determined.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel surgical fixation wire.  
1.2 Units—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 the 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.

ABSTRACT
This specification covers the requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants. Bar and wire shall be furnished, as specified, in the hot-worked, annealed, cold -worked, or extra hard condition. Fine wire shall be furnished, as specified, in the cold-drawn condition. Types of finish available for bar and wire products are cold-drawn, pickled, ground, and ground and polished. On the other hand, types of finish available for fine wire products are cold-drawn, ground, and ground and polished. The heat analysis shall conform to the requirements as to chemical composition specified and the material shall contain no delta ferrite, chi, or sigma phases when it is examined by metallography. Different tests shall be performed in order to determine the following mechanical properties of the wire and bar: ultimate tensile strength, yield strength, elongation, and Brinell hardness.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel sheet and strip used for the manufacture of surgical implants. Sheet and strip shall be furnished as specified, in the annealed or cold-worked condition. Types of finish available in sheet and strip are dull cold rolled, bright cold rolled, intermediate polished, general-purpose polished, dull satin-finished, high luster finish, and mirror finish. Tensile test, hardness test, and intergranular corrosion susceptibility test shall be performed in accordance with specified requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel sheet and strip used for the manufacture of surgical implants.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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.

ABSTRACT
This specification covers the chemical, mechanical, and dimensional requirements for wrought seamless nickel-titanium shape memory alloy tubes used for the manufacture of medical devices and surgical implants. Tubes shall be furnished in the superelastic condition, and the outer surface shall have a pickled, ground, or mechanically polished finish, or as agreed upon between purchaser and supplier. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms. This specification applies precisely to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness. The mechanical properties to which the tubes shall conform are ultimate tensile strength (UTS), uniform elongation, upper plateau strength, lower plateau strength, and residual elongation.
SCOPE
1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F2063.  
1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness.  
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses (inch-pound units) are for information only.  
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.

ABSTRACT
This specification covers the material requirements for low-carbon (UNS R31537), high-carbon (UNS R31538), and dispersion-strengthened (UNS R31539) cobalt-28chromium-6molybdenum alloy high-strength forgings used for the manufacture of surgical implants. The properties specified here specifically apply to finished or semifinished parts that receive no subsequent thermomechanical processing. The materials shall be in the form of bars, rods, or wires suitable for forging by hammering, pressing, rolling, extruding, or upsetting. The forgings shall adhere to chemical composition, ultimate tensile strength, yield strength, elongation, reduction of area, and hardness requirements.
SCOPE
1.1 This specification covers requirements of cobalt-28 chromium-6 molybdenum alloy (UNS R31537, R31538, R31539) high-strength forgings for the manufacture of surgical implants. The properties specified in this document specifically apply to finished or semifinished parts that receive no subsequent thermomechanical processing.  
1.2 Wrought material to be used as forging stock in the manufacture of forgings conforming to this specification, typically hot worked and unannealed with a surface finish suitable for forging, shall be fabricated and supplied in accordance with Specification F1537.  
1.3 Units—The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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.

ABSTRACT
This specification covers the requirements for wrought cobalt-35nickel-20chromium-10molybdenum alloy for use in the manufacture of surgical implants. The alloy shall be manufactured into plates, sheets, and foils in the annealed, cold-worked, or cold-worked and capability-aged condition. The plates may be available in ground or dull finish, while the sheet and foil may be of dull cold-rolled, bright cold-rolled, intermediate polished, general-purpose polished, dull satin finished, high luster finish, or mirror finish. In addition, plate edges may be of rolled edge or approximate square edge, while for sheet and foil, edges may be approximate square edge or an edge produced by slitting or shearing. Heat and product analyses as well as tests for ultimate tensile strength, yield strength, elongation, hardness, and average grain size shall be performed and shall conform to the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of plate, sheet, and foil to be used in the manufacture of surgical implants.  
1.2 Units—The SI units in this standard are the primary units. The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with this standard.  
1.3 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.

ABSTRACT
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.
SCOPE
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 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.6 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.

ABSTRACT
This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions. The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or cold finished and annealed or heat treated. Surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished. Major elements shall be analyzed by direct current plasma spectrometry, atomic absorption, inductively coupled plasma spectrometry, X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method. Carbon shall be measured by combustion and hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured by inert gas fusion. The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method must be used to assure the alloy formulation in terms of transformation temperature. Mechanical properties of the samples such as tensile strength and elongation shall be determined after annealing.
SCOPE
1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubes containing nominally 54.5- to 57.0-weight percent nickel and used for the manufacture of medical devices and surgical implants.  
1.2 Requirements are for mill product, measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components. Finished NiTi cold-worked tube should be considered under Specification F2633.  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22chromium-13nickel-5manganese-2.5molybdenum stainless steel alloy bar and wire for surgical implants (UNS S20910). Materials shall be tested and shall conform to chemical requirements such as chemical composition, and product analysis; metallurgical requirements such as inclusion; and mechanical requirements such as dimension, tensile strength, yield strength, elongation, and Brinell hardness.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22 chromium – 13 nickel – 5 manganese – 2.5 molybdenum stainless steel alloy bar and wire for surgical implants.  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of each other. Combining values form the two systems may result in non-conformance with the standard.  
1.3 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum (UNS S29225) low-nickel stainless steel alloy bars and wires for surgical implants. The alloys shall be furnished in the annealed or cold-worked condition, and finished cold-drawn, pickled, ground, ground and polished, or as specified by the purchaser. Mechanical properties to which the alloys shall conform are ultimate tensile strength, yield strength, elongation, and reduction of area.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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 and health 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.

ABSTRACT
This specification covers the requirements for stainless steel forgings for surgical implants. Materials for forgings shall be bars or wire and shall be forged by hammering, pressing, rolling, extruding, or upsetting. The material shall comply with the manufacturing procedure, chemical composition, mechanical requirements, and test methods indicated in this specification. Mechanical testing includes tension, tensile, elongation, and hardness tests. Special tests shall also be done such as corrosion tests, grain size, and fluorescent penetrant inspection.
SCOPE
1.1 This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms to Specifications F138 (UNS S31673), F1314 (UNS S21910), F1586 (UNS S31675), F2229 (UNS S29108), or F2581 (UNS R56320).  
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 the other, and values from the two systems shall not be combined.  
1.3 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strips, sheets, plates, bars, billets, forgings, and wires used for the manufacture of surgical implants. The four grades identified here are defined as follows: Grade 1—UNS R50250; Grade 2—UNS R50400; Grade 3—UNS R50550; and Grade 4—UNS R50700. Mill products may be supplied with a descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished finish, or as specified by the purchaser. Materials shall be furnished in the hotworked, cold-worked, forged, annealed, or stress-relieved condition. Mechanical properties to which the titanium materials shall conform are ultimate tensile strength, yield strength, elongation, and reduction of area.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strip, sheet, plate, bar, billet, forging, and wire used for the manufacture of surgical implants.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.3 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.

ABSTRACT
This specification covers the requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel- 7molybdenum alloy in the form of wire and strip used for the manufacture of surgical implants. The heat analysis shall conform to the prescribed chemical composition requirements of grade 1 or 2. The tensile strength, hardness, yield strength, elongation, and microstructure shall be tested to meet the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel-7molybdenum alloy in the form of wire, strip and bar used for the manufacture of surgical implants.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

ABSTRACT
This specification covers the requirements fro wrought zirconium-2.5niobium alloy for use in surgical implant applications. The material shall be manufactured into bars or wires by multiple vacuum melting in arc furnaces, by electron beam melting, or by other melting processes conventionally used for reactive metals. The material shall be in the annealed condition, with the surface descaled or pickled, abrasively blasted, chemically milled, ground, machined, peeled, or polished. Heat and product analyses and tests for tensile strength, yield strength, and elongation shall be performed and shall conform to the requirements specified. In addition, the material shall have a microstructure consisting of a fine dispersion of the alpha and beta phases as a result of processing in the alpha plus beta field, with no coarse, elongated alpha platelets.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought zirconium-2.5niobium 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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the chemical composition requirements specified. Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories in the measurement of chemical content. Tension test and bend test shall be performed to meet the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants.  
1.2 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.  
1.3 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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants, and may be furnished as descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or cold drawn. The alloy shall be multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals. Heat analysis shall conform to the chemical composition requirements prescribed for aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and titanium. The material shall conform to the specified requirements for mechanical properties such as ultimate tensile strength, yield strength, and elongation. A minimum of two tension tests from each lot shall be performed. Special requirements for the microstructure are detailed as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants (1-7).2  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants, and may be furnished as descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or cold drawn. The alloy shall be multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals. Heat analysis shall conform to the chemical composition requirements prescribed for aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and titanium. The material shall conform to the specified requirements for mechanical properties such as ultimate tensile strength, yield strength, and elongation. A minimum of two tension tests from each lot shall be performed. Special requirements for the microstructure are detailed as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants (1-7).2  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.