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.
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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 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E8/E8M Test Methods for Tension Testing of Metallic Materials
E10 Test Method for Brinell Hardness of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
E140 Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness, Superficial Hardness, Knoop Hardness, and Scleroscope Hardness
E345 Test Methods of Tension Testing of Metallic Foil
E384 Test Method for Knoop and Vickers Hardness of Materials
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
SI10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
ISO9001 Quality Management Systems--Requirements Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
cobalt alloys (for surgical implants); cobalt-nickel alloy; metals (for surgical implants)cobalt alloys; Chromium surgical implant applications--specifications; Cobalt alloys (for surgical implants)--specifications; Cobalt-nickel surgical implant alloy; Metallic surgical implant materials--specifications; Molybdenum (surgical implants)--specifications; Nickel surgical implant applications--specifications; UNS R30035 (Co-Ni-Cr-Mo alloy, MP-35-N);
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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