ASTM International - ASTM F2759-19

Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices

active
Buy Now
Organization: ASTM International
Publication Date: 1 December 2019
Status: active
Page Count: 6
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
significance And Use:

4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal... View More

scope:

1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.

1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.

1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal devices.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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.

Document History

ASTM F2759-19
December 1, 2019
Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
4.1 This guide aims to provide guidance for a range of assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices...
April 15, 2011
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
This guide aims to provide guidance for a range of various assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal...
February 1, 2009
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable...
Advertisement