ASTM F1357-23 + Redline

ASTM F1357-23 + Redline

Standard Specification for Articulating Total Wrist Implants

Availability: In stock

€65.00

Details

1.1 This specification describes total wrist implants used to provide functioning articulation by employing radial and carpal components.

1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants (with or without grommets), and those devices used for custom applications.

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

1.4 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.

1.5 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.


Rationale:

This specification covers total wrist implants that provide articulation function through radial carpal components. However, this specification does not include implants with ceramic coated or porous coated surfaces, one-piece elastomeric implants, and those used for custom applications. Implants covered by this specification are of the constrained, partially constrained, or unconstrained joint prosthesis type. The implants shall be manufactured from biocompatible materials made of unalloyed titanium, cobalt-28chromium-6molybdenum alloy, wrought cobalt-20chromium-15tungsten-10nickel alloy, wrought titanium-6aluminum-4vanadium extra low interstitial alloy, wrought 35cobalt-35nickel-20chromium-10molybdenum alloy, wrought cobalt-20nickel-20chromium-3.5molybdenum-3.5tungsten-5iron alloy, cobalt-28chromium-6molybdenum alloy, titanium-6aluminum-4vanadium alloy, or wrought cobalt-28chromium-6molybdenum alloy with dimensions in conformity to the requirements specified. Tests for polymeric creep (cold flow), wear, and range of motion of the device as well as in vitro laboratory testing shall be performed and shall conform to the requirements specified. Per service requirement, metallic implants shall undergo fluorescent penetrant inspection, while cast metallic implants shall undergo radiography.

Additional Info

Author American Society for Testing and Materials (ASTM International)
Committee F04.22 - Committee F04 on Medical and Surgical Materials and Devices
Published by ASTM
Document type Standard
Theme ,Implants for surgery, prothetics and orthotics
ICS 11.040.40 : Implants for surgery, prosthetics and orthotics
Number of pages 6
Replace ASTM F1357-14(2019) + Redline
Set ASTM Volume 13.01 - Multi-User - Single-Site Online
Keyword F1357

You may also be interested in the following product(s)