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ASTM F688-05

(Specification)

Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

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 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.

General Information

Status
Historical
Publication Date
31-Jul-2005
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.12 - Metallurgical Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F688-00 - Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants(UNS R30035)
Effective Date
01-Aug-2005
Replaced By
ASTM F688-10 - Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
Effective Date
01-Dec-2010
Referred By
ASTM F961-20 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Effective Date
01-Aug-2005
Referred By
ASTM F2527-16 - Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
Effective Date
01-Aug-2005

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ASTM F688-05 - Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)ASTM F688-05 - Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
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ASTM F688-05 - Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F688 – 05
Standard Specification for
Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
ThisstandardisissuedunderthefixeddesignationF688;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* Materials on Muscle and Bone
2.2 American Society for Quality Standard:
1.1 This specification covers the chemical, mechanical, and
ASQ C1 Specification of General Requirements for a Qual-
metallurgical requirements for wrought cobalt-35nickel-
3
ity Program
20chromium-10molybdenum alloy (UNS R30035) in the form
of plate, sheet, and foil to be used in the manufacture of
3. Terminology
surgical implants.
3.1 Descriptions of Terms Specific to This Standard:
1.2 The values stated in inch-pound units are to be regarded
3.1.1 capability—usedtoindicatetheabilityofcoldworked
as the standard. The SI equivalents in parentheses are for
material to attain specific mechanical properties after thermal
information only.
aging treatment.
2. Referenced Documents 3.1.2 foil—material under 0.005 in. (0.127 mm) in thick-
2
ness.
2.1 ASTM Standards:
3.1.3 lot—the total number of mill products produced from
E8 Test Methods for Tension Testing of Metallic Materials
the same melt heat under the same conditions at essentially the
E10 Test Method for Brinell Hardness of Metallic Materials
same time.
E18 Test Methods for Rockwell Hardness of Metallic Ma-
3.1.4 plate—as used in this specification, material 0.1875
terials
in. (4.76 mm) and over in thickness.
E29 Practice for Using Significant Digits in Test Data to
3.1.5 sheet—as used in this specification, material 0.005 in.
Determine Conformance with Specifications
(0.127 mm) to under 0.1875 in. (4.76 mm) in thickness.
E92 Test Method for Vickers Hardness of Metallic Materi-
als
4. Ordering Information
E112 Test Methods for Determining Average Grain Size
4.1 Inquiries and orders for material under this specification
E140 Hardness Conversion Tables for Metals Relationship
shall include the following information:
Among Brinell Hardness, Vickers Hardness, Rockwell
4.1.1 Quantity (weight or number of pieces),
Hardness, Superficial Hardness, Knoop Hardness, and
4.1.2 ASTM Designation,
Scleroscope Hardness
4.1.3 Form (plate, sheet, foil),
E345 Test Methods of Tension Testing of Metallic Foil
4.1.4 Condition (see 5.1),
E384 Test Method for Microindentation Hardness of Mate-
4.1.5 Mechanical properties (if applicable for special con-
rials
ditions),
F562 Specification for Wrought 35Cobalt-35Nickel-
4.1.6 Finish (see 5.2 and 5.3),
20Chromium-10Molybdenum Alloy for Surgical Implant
4.1.7 Edge (see 5.4 and 5.5),
Applications (UNS R30035)
4.1.8 Applicable dimensions, including size, thickness,
F981 Practice forAssessment of Compatibility of Biomate-
width, and length (exact, random, or multiples) or print
rials for Surgical Implants with Respect to Effect of
number, and
4.1.9 Special requirements.
1
This specification is under the jurisdiction of ASTM Committee F04 on
5. Manufacture
Medical and Surgical Materials and Devices and is the direct responsibility of
5.1 Condition—Plate, sheet, and foil shall be furnished as
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Aug. 1, 2005. Published August 2005. Originally specified in the annealed, cold-worked, or cold-worked and
approved in 1980. Last previous editioin approved in 2000 as F688 – 00. DOI:
capability-aged condition.
10.1520/F0688-05.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203.
*A Summary of Changes section appears at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F688 – 05
TABLE 1 Sheet Mechanical Properties
5.2 Finishes for Plate:
5.2.1 Types of finish available for plate are ground finish Ultimate Tensile Yield Strength Elongation, Rockwell
Condition Strength, min, psi (0.2 % offset), min, % in 2 Hardness,
produced by surface grinding or continuous belt sanding and
A A
(MPa) min, psi (MPa) in.or50mm min
dull finish produced by chemical descaling. B
Annealed 115 000 (792) 45 000 (310) 45 87 HRB
5.3 Finishes for Sheet and Foil: 48 % cold worked 197 000 (1357) 195 000 (1343) 3 43 HRC
A
5.3.1 Types of finish available for she
...

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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off