Tag: Titanium alloys

New ASTM F2989 covers Unalloyed Titanium Components Used for Surgical Implants

There’s a new ASTM F2989 2013 Edition, “Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications.”  The document covers the chemical, mechanical and metallurgical requirements for three grades of metal injection molded unalloyed titanium components to be used in the manufacture of surgical implants.

The metal injection molded (MIM) titanium in ASTM F2989-13 makes use of 2 types as well as the 3 grades.  The chemical composition matches up to ASTM F67 except for the maximum oxygen level of Grade MIM 3.

The standard provides for both the use of SI (preferred) and inch-pound units without the use of the ASTM F2989/F2989M designator.  This is because ASTM is in the process of implementing a migration path that should culminate with total reliance on SI units by 2018.

Another thing to note in ASTM F2989 is the Appendix X2 on biocompatibility.  It is informational and provides the user with a basis for evaluating the level of biological response to be expected when using this material.  Appendix X1 – Rationale – includes the purpose;  chemistry, process history and mechanical properties; fatigue; binders; and units of measurement.

ASTM F2989 was developed not only for manufacturers and medical device companies, but also to serve as a basis for certification by testing laboratories and as a guideline for regulatory bodies.  It supports the design of new shapes and allows MIM components to be directly compared to parts made by more conventional methods.

The 2013 Edition is an update of the ASTM F2989 2012 Edition.  For the details on the changes, you’ll want to purchase the redline edition.  This comes with a clean copy of the 2013 revision plus a copy of the 2012 document with the changes marked clearly for your review.

You can order ASTM Standards in both paper and pdf format from Document Center at our web store, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are your Standards Experts and we’re here to help you keep your conformance documentation complete and current.

New ASTM B600 2011 Edition released on Standard Guide for Descaling and Cleaning Titanium and Titanium Alloy Surfaces

ASTM B600-11 Edition, “Standard Guide for Descaling and Cleaning Titanium and Titanium Alloy Surfaces,” has just been released.  This new 2011 edition replaces the ASTM B600-09 which is now obsolete.

The guide covers a cleaning and descaling procedure useful to producers, users, and fabricators of titanium and titanium alloys for the removal of ordinary shop soils, oxides, and scales resulting from heat treatment operations and foreign substances present as surface contaminants.

ASTM B600 is not intended to be mandatory for removal of any of the indicated soils but rather serve as a guide when titanium and titanium alloys are being processed in the wrought, cast, or fabricated form.

It is recommended that the materials shall be subjected to soil removal prior to heat treatment or application of acid treatment. Mechanical descaling methods such as sandblasting, shot blasting, and vapor blasting may be used to remove hot work scales and lubricants from titanium surfaces.

Recommended post treatment of shot or abrasive blasted titanium surfaces may include acid pickling to ensure complete removal of surface contaminants. For chemically milled materials, salt bath conditioning may be required to remove the oxygen-contaminated layer. Acid etching treatment may be required following mechanical abrading or chemical conditioning of materials to completely clean the surface.

This new ASTM guide and all ASTM standards are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our staff is available from 8 am to 5 pm, Monday through Friday, California time.  We have an extensive collection of obsolete ASTM revisions as well.