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One of the most commonly used materials for body jewelry, the ASTM F136 – Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) has been revised to F136-13 developed by Committee F04.12, ASTM BOS Volume13.01.
The new version changes are in section 9. Special Requirements
A forum participant asked:
please discuss 316l and implant grade 316lvm grade stainless steel
They added a link to an essay titled
“Body Jewelry Materials. Understanding Implant Grade Surgical Steel“
The easy answer:
*AISI and SAE do not establish standards for biocompatibility.
More detail: ASTM ? ANSI ? ISO
One thing to know is that ISO and ASTM are both international organizations for standards, but ISO is restricted to members of national standards bodies such as ANSI. Individuals or companies cannot become ISO members.
ASTM members are comprised of representatives of both government and stakeholders in related business, such as me. I joined ASTM in the mid 1990’s to represent the needs and learn more about the responsibilities of the body piercing business, and have been able to attend conferences, contribute my research based evaluations and vote for standards that affect us as body artists.
ISO voting is done for the US by ANSI. ASTM makes recommendations to ANSI. ANSI has typically voted in accordance with the recommendations of the ASTM.
ASTM F138-13a specifies chemical, mechanical and metallurgical refinements for 316 series steel alloys for surgical implant. It doesn’t really matter if the material is 316L, 316LVM, etc. The material is only acceptable for body jewelry when specified for human surgical implant and validated for this purpose to a peer reviewed scientific standard such as ASTM or ISO provides. AISI/SAE
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Previously Presented at BMXnet, UKAPP, APP, LBP, 2º Congresso Educativo para Perfuradores Corporais da América do Sul – ATPB 2013
1) What is Anodizing?
Anodizing is a process where a coating is built up on the surface of certain metals (titanium, niobium, tantalum, aluminum, magnesium and zinc) by heating, with chemicals, or by electricity. In the case of titanium, the coating that is built up is a layer of titanium dioxide.
Some of my colleagues have already learned of this from my biomaterials presentations at APP 2010 and BMXnet conferences. This reflects upon imported jewelry, and the situations that can arise when quality controls are not normalized. So far, most of the response I get from US distributors of medical titanium alloys is for ELI material they only use domestic melts.
I’ve been talking with fellow ASTM committee members about international sourcing for F136 Ti in particular. They all only use domestic melts for ELI material from Perryman, ATI and Fort Wayne Metals for example . Therefore when companies in China or elsewhere want to make jewelry from F136 they either have to buy from a US or EU source that has a distributor in their area, eg Taiwan, or buy from an local mill melt, that quite possibly won’t meet FDA, BSI, ISO etc.