Safe steel for body jewelry?

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:

Neither are surgical implant materials. These are engineering specifications.
*AISI and SAE do not establish standards for biocompatibility.

me+.lMore 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.

The 2013 update that my ASTM F04.12 committee just voted to approve for the most common steel alloy for surgical implant is also most the commonly used for body jewelry, F138.

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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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Researchers Develop Off-Grid Sterilization with Solar Steam

Original article: Researchers Develop Off-Grid Sterilization with Solar Steam.

Copyright 2013 by Virgo Publishing https://www.infectioncontroltoday.com/
Posted on: 07/22/2013

Rice University graduate student Oara Neumann, left, and scientist Naomi Halas are co-authors of a new study about a highly efficient method of turning sunlight into heat. They expect their technology to have an initial impact as an ultra-small-scale system to treat human waste in developing nations without sewer systems or electricity. Photo by Jeff Fitlow/Rice University.

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Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes

Read the full textEffects of Non Condensable Gases on Sterilization

Summary:

A gravity displacement (class N) steam sterilization process can not reliably remove gases from hollow or porous items, resulting in areas that do not get sterilized, and the failure of the load. They should not be used for body jewelry, needles, tattoo tubes or textiles.

REVIEW

395 CENTRAL SERVICE Volume 13 2005

ZENTRAL STERILISATION

Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes

U. Kaiser

Keywords

  • steam sterilisation process
  • non-condensable gases (NCGs)
  • process challenge device (PCD)

Introduction

The dangers posed by non-condensable gases (NCGs) in steam sterilisation processes have long been underestimated. Biological indicators, or the best chemical indicators on the market, do not signal the presence of a NCG content of up to 10% in a sterilisation process so long as there is mixing of steam and NCGs in the sterilisation chamber.

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Titanium body jewelry

Titanium!

What Titanium materials are best for body jewelry? My articles at https://jewelry.piercing.org/ and https://brnskll.com/shares/titanium-standards-why-not-g23/ explain that the two most effective Titanium standards are alloyed ASTM F136 and pure ASTM F67, the most common being the former as it is stronger, harder and easier to polish. Both are used for permanent surgical implants.

Statim misconceptions

Did you read confusing STATIM information in the old APP Procedure Manual? (prior to 2013 edition)

STATIM in the old APP Procedure Manual

Get the 2013 APP procedure manual
Get the 2013 APP procedure manual

In the current 2013 edition of the APP Procedure Manual, I helped correct the previously confusing references to Statim autoclaves.

The current 2013 version of the guidelines refer to the Statim and the acceptable use of unwrapped sterilization methods.

Quotes from the 2013 APP procedure manual:

Sterilization Methods:

Benchtop Sterilization

 

Aseptic Field

The actual procedure surface is referred to as an “aseptic field,” and is a sterilized surface that becomes exposed to air contact only at the beginning of the piercing procedure. The aseptic field used by most piercers is the sterile inside surface of a freshly opened large autoclave or sterile glove package, Statim cassette, rigid sterilization container, or sterilized tray. Once the package is opened, sterile tools, needles, jewelry, and disposables can be dropped onto the inside surface for use. The exterior of sterilized packages such as those containing the jewelry should not touch the aseptic field; the contents should be carefully dispensed onto it.

DISPOSABLE SUPPLIES

To minimize the risk of cross-contamination and to ensure that piercing room procedures are as clean as possible, many components of the tray setup must be disposable. Unless supplies are purchased presterilized* or will be sterilized in an autoclave immediately prior to the procedure, all disposables must be individually packaged in autoclave bags, sterilized, and remain intact in their pouches stored in enclosed, nonporous drawers or containers until use. Disposable materials that must be sterilized include: marking implements, piercing needles, corks or synthetic stoppers, elastic bands, swabs, and gauze.

* This includes only FDA-cleared items that are commercially sterilized according to accepted medical standards. The supplier must make documentation of appropriate sterilization available.

The following is to clarify the inconsistencies in the previous editions: 

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Anodizing Titanium and Niobium Body Jewelry

Sign up for the workshop with Brian Skellie

APP ConferenceOnline Anodizing is Awesome!”

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”.

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Nonconforming Imported Titanium

Ti: what can slip by undetected

Ti: what can slip by undetected*En Español*

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.

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