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
I strongly disagree with the opinion which the author in that linked blog post stated:
“While we refer to steel as implant grade, it is important to address the reality that basic body piercings are not implants. Implants are completely contained in the skin. If steel that passes the ASTM F-138 standard is considered implant-safe steel, then 316L and 316LVM steel should be considered more than adequate for body piercing.”
- This syllogism could be a misunderstanding or misdirection. Socrates was a man, but all men are not Socrates. Many types of surgical devices that are implanted are not “completely contained” in the body.
Implants and Prosthetics
Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues.
Some implants are made from skin, bone or other body tissues. Others are made from metal, plastic, ceramic or other materials.
Implants can be placed permanently or they can be removed once they are no longer needed. For example, stents or hip implants are intended to be permanent. But chemotherapy ports or screws to repair broken bones can be removed when they no longer needed.
Body jewelry does not qualify as a medical device, but can meet similar safety standards as those designated for the biocompatibility of surgical implants.
- ASTM standard specifications for surgical implant materials are scientifically rigorous and well documented recipes to best ensure successful results. This does not compare to the opinion of feeling that other less refined base materials would be adequate for exposure to the same conditions that qualify for an implant. Damaged wound tissue must heal in contact with the item, therefore the item can be proven through scientific validation to be safe in contact with both healing and intact tissue.
- Opinions such as “more than adequate” and “try it yourself” are not valid arguments versus using a validated surgical implant material specification.
In addition, these arguments seem to regard only the chemical heat analysis, and ignore that the metallurgical and mechanical properties are also equally important in the surgical implant standards. A similar chemistry could still have inclusions of carbon and other irritant materials, or a delta ferrite microstructure that would prevent complete passivation and allow for corrosion.
It seems to be no more than an excuse for selling items that are not validated for safety.
The bit about how it is impossible to test every piece is untrue :
“Every reputable supplier will be able to produce a mill cert, but the mill cert is only as valid as the supplier’s reputation. It is impossible to test every piece of jewelry a supplier carries. The mill cert is only relevant to the batch that was tested.”
Reputation does not absolve a manufacturer of responsibility. The raw material is tested prior to making jewelry, and certified on the contract from the material source to the specifications demanded by the manufacturer. You only have to test random samples after that, provided that only that certified source material is used.
The certification from those sample tests would not be from the mill/supplier but should be from an independent third party.
To keep track of jewelry that is used for initial piercing, the brand, invoice number and jewelry description should be recorded along with the client information. The invoice should clearly show that the jewelry is made from materials validated to meet or exceed ASTM and or ISO biocompatibility standards, with certificates of tests available from the manufacturer.
This way, if a piercer installs brand X jewelry, and the client has problems wearing brand Y, the issues can be disassociated and kept distinct. Visual inspection under magnification should be sufficient to determine if the jewelry matches an example of the same item in question from brand X.
This is also untrue and misleading:
“In truth, the best (and only) way to find out if a supplier’s body jewelry is up to par is to try it out. Consistency speaks more volume in our industry than any lab test or mill certification document”
It is not difficult to for the manufacturer to simply purchase validated safe materials to begin with. If the material in question is not already tested extensively for biocompatibility, the clients become the test subjects without the ethical controls of a clinical trial.
If I want to make jewelry for initial piercing or long term wear, then I should purchase and use only materials that are proven safe for surgical implant and that are tested and certified to a validated surgical implant standard (ASTM or ISO ), and use good manufacturing practices that do not damage the material or render it unsuitable for use, such as by overheating or fatigue.
As a manufacturer, I could then rest assured that my jewelry material was safe, and provide the certificate of tests for the raw materials to all of my customers.
This is how it is done with standard quality body jewelry, and has for over a decade.
If I was to choose to use a material that was not already tested and specified for surgical implantation, then I am ethically obligated to have the raw material tested for biocompatibility before I started to make jewelry out of it.