ASTM F2181-09 - 1.2.2009
 
1. Scope

1.1 This specification covers the requirements for five compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F 138, F 1314, F 1586, F 2229, or F 2581. This specification addresses those product variables that differentiate wrought seamless tubing from the bar and wire product forms covered in these specifications.

1.2 This specification applies to cold finished, straight length tubing from 3 to 34 mm (0.125 to 1.315 in.) nominal outside diameter (OD) and 0.5 mm (0.020 in.) and greater 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

ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 9001

Quality Management System--Requirements

ISO 5832-9

Implants for Surgery--Metallic Materials--Part 9: Wrought High Nitrogen Stainless Steel

ISO 5832-1

Implants for Surgery--Metallic Materials--Part 1: Wrought Stainless Steel

IEEE/ASTM SI?10

American National Standard for Use of the International System of Units (SI): The Modern Metric System

ASME Y14.5.1M

Mathematical Definition of Dimensioning and Tolerancing Principles