ASTM-F2181 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

ASTM-F2181 - 2020 EDITION - CURRENT
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This specification covers the requirements for three compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Materials shall be tested and shall conform to chemical composition, metallurgical requirements, and mechanical properties. Materials and manufacture are also detailed.

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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 Specification F138, F1314, F1586, F2229, or F2581. 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 SI units or inch-pound units are to be regarded separately as standard. Inch-pound units are shown in brackets. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other and values from the two systems shall not be combined.

1.5 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.

1.6 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.

Keywords

metals (for surgical implant); seamless tubing; stainless steel; surgical applications tubing; surgical implants;

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F2181-20

Revision Level

2020 EDITION

Status

Current

Modification Type

Revision

Publication Date

July 21, 2020

Document Type

Specification

Page Count

5 pages

Committee Number

F04.12