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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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 , , , , or . 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 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 nonconformance 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.
ISO StandardsISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes ISO 5832-1 Implants for Surgery--Metallic Materials--Part 1: Wrought Stainless Steel ISO 5832-9 Implants for Surgery--Metallic Materials--Part 9: Wrought High Nitrogen Stainless Steel ISO 9001 Quality Management System--Requirements
ASME StandardASME Y14.5.1M Mathematical Definition of Dimensioning and Tolerancing Principles
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
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ASTM F2181-14, Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants, ASTM International, West Conshohocken, PA, 2014, www.astm.orgBack to Top