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.
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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 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.
SI10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
cobalt alloy; small diameter, metals (for surgical implant); surgical applications, tubing; surgical implants; tubing; Cobalt alloys (for surgical implants)--specifications; Surgical implants--specifications; Tubing; UNS R30003; UNS R30008; UNS R30035 (Co-Ni-Cr-Mo alloy, MP-35-N); UNS R30605 (Co-Cr-Ni-W alloy, L-605); UNS R31537 (Co-Cr-Mo alloy);
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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