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.
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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 F 138 (for seamless) or Specification F 139 (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 inch-pound or SI units are to be regarded separately as standard. Inch-pound units are shown in parentheses. 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
ISO9001 Quality Management Systems--Requirements
ASMEY14.5.1M Mathematical Definition of Dimensioning and Tolerancing Principles
metals (for surgical implant); small diameter; stainless steel; surgical applications tubing; surgical implants; tubing; Chromium surgical implant applications--specifications; Orthopaedic medical devices--specifications (Cr alloy); Small diameter surgical tubing; Stainless steel surgical applications--specifications ;
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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Citing ASTM Standards
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