ASTM F2181-02a - 10.11.2002
 
1. Scope

1.1 This specification covers the requirements for three 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, or F 1586. 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 0.125 to 1.315 in. (3.18 to 33.4 mm) nominal outside diameter (OD) and 0.018 in. (0.46 mm) and greater nominal wall thickness.

1.3 The values stated in inch-pound units are to be regarded as the standard. The SI units in parentheses are approximate.

1.4 The specifications in will be referred to as the ASTM material standard(s) in the remainder of this specification.

 
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