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ASTM F2527-05e1

(Specification)

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)

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)

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 F 90, F 562, F 688, F 1058 or F 1537, 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 0.250 in. (6.3 mm) and smaller nominal outside diameter (OD) and 0.030 in. (0.76 mm) and thinner nominal wall thickness.
1.3 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.

General Information

Status
Historical
Publication Date
30-Sep-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 F2527-05 - 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-Oct-2005
Replaced By
ASTM F2527-10 - 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-Dec-2010

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ASTM F2527-05e1 - 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)ASTM F2527-05e1 - 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)
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ASTM F2527-05e1 - 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)
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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
´1
Designation: F2527 – 05
Standard Specification for
Wrought Seamless and Welded and Drawn Cobalt Alloy
Small Diameter Tubing for Surgical Implants (UNS R30003,
1
UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
This standard is issued under the fixed designation F2527; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Section references in Section 5 were editorially changed in April 2006.
1. Scope F1058 Specification for Wrought 40Cobalt-20Chromium-
16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for
1.1 This specification covers the requirements for wrought
Surgical Implant Applications (UNS R30003 and UNS
seamless and welded and drawn cobalt alloy small diameter
R30008)
tubing used for the manufacture of surgical implants. Material
F1537 Specification for Wrought Cobalt-28Chromium-
shall conform to the applicable requirements of Specifications
6MolybdenumAlloys for Surgical Implants (UNS R31537,
F90, F562, F688, F1058 or F1537, Alloy 1. This specification
UNS R31538, and UNS R31539)
addresses those product variables that differentiate small diam-
2.2 ASTM Standards:
eter medical tubing from the bar, wire, sheet and strip product
A632 Specification for Seamless and Welded Austenitic
forms covered in these specifications.
Stainless Steel Tubing (Small-Diameter) for General Ser-
1.2 This specification applies to straight length tubing with
vice
0.250 in. (6.3 mm) and smaller nominal outside diameter (OD)
E8 Test Methods for Tension Testing of Metallic Materials
and 0.030 in. (0.76 mm) and thinner nominal wall thickness.
E45 Test Methods for Determining the Inclusion Content of
1.3 The values stated in inch-pound units are to be regarded
Steel
as standard. The values given in parentheses are mathematical
E112 Test Methods for Determining Average Grain Size
conversions to SI units that are provided for information only
3
2.3 ISO Standards:
and are not considered standard.
ISO 5832- 5 Implants for Surgery—Metallic Materials Part
2. Referenced Documents
5: Wrought Cobalt, Chromium, Tungsten, Nickel Alloy
2
ISO 5832- 6 Implants for Surgery—Metallic Materials Part
2.1 ASTM Material Standards:
6: Wrought Cobalt, Nickel, Chromium, Molybdenum
F90 Specification for Wrought Cobalt-20Chromium-
Alloy
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
ISO 5832- 7 Implants for Surgery—Metallic Materials Part
tions (UNS R30605)
7: Wrought Cobalt, Chromium, Molybdenum Alloy
F562 Specification for Wrought 35Cobalt-35Nickel-
ISO 5832- 8 Implants for Surgery—Metallic Materials Part
20Chromium-10Molybdenum Alloy for Surgical Implant
8: Wrought Cobalt, Nickel, Chromium, Molybdenum,
Applications (UNS R30035)
Tungsten, Iron Alloy
F688 Specification for Wrought Cobalt-35Nickel-
ISO 5832- 12 Implants for Surgery—Metallic Materials
20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil
Part 12: Wrought Cobalt, Chromium, Molybdenum Alloy
for Surgical Implants (UNS R30035)
ISO 6892 Metallic Materials—Tensile Testing
2.4 American Society for Quality Standard:
1
This specification is under the jurisdiction of ASTM Committee F04 on
ASQ C1 Specification of General Requirements for a Qual-
Medical and Surgical Materials and Devices and is the direct responsibility of
4
ity Program
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2005. Published October 2005. DOI: 10.1520/
F2527-05E01.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036.
4
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
´1
F2527 – 05
TABLE 1 Permissible Variation in OD and ID Dimensions
3. Terminology
Permissible Variation
3.1 Definitions of Terms Specific to This Standard:
Nominal OD or ID
A
from Nominal
in. (mm)
3.1.1 average wall thickness—the arithmetic average of the
in. (mm)
minimum wall thickness and the maximum wall thickness
Less than 0.060 (1.54) 60.0005 (0.013)
measured on any one transverse cross section of the tube. 0.060 to 0.250 (1.54 to 6.30) incl. 60.001 (0.025)
A
3.1.2 concentricity—two times the offset between the cen-
Unless otherwise specified, size tolerances are plus and minus as shown in
the tabl
...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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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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1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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Standard Specification and Test Methods for Metallic Medical Bone Screws

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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