An opportunity to share ideas with my colleagues hosted by Ryan Ouellette from Precision Body Arts.
Listen for free on itunes apple podcasts, google podcasts, or stream from the link below.Ryan Ouellette: November 9 at 6:34pm · Nashua, NH, United States ·
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
The easy answer:
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 USA by ANSI. ASTM makes recommendations to ANSI. ANSI has typically voted in accordance with the recommendations of the ASTM.
ASTM F04 and ISO TC 150 have merged to facilitate the flow of information.
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
As an aside: I don’t personally use steel alloy jewelry for initial piercings. I prefer pure unalloyed metals or simpler alloys with a greater margin of safety and less reactivity in the body.
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Previously Presented at BMXnet, UKAPP, APP, LBP, 2º Congresso Educativo para Perfuradores Corporais da América do Sul – ATPB 2013 & more events
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. Titanium dioxide, which is also known as titanium oxide, occurs naturally on the surface of titanium. Anodizing the surface of titanium can be done by the use of heat but the results are not easily controlled. The most common method is to form an oxide layer on the surface with the use of electricity. The way that this is done is with a variable power supply in which an electrode is connected to the positive side (anode), and one to the negative side (cathode). Both are then submerged into a mildly conductive solution, thus completing the electrical circuit. The piece that is to be anodized is connected to the positive side, and that is why the process is called “anodizing”.
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.