Questions you can use to determine if a body jewelry material is tested to relate to an appropriate standard specification
- Is contact information available for the supplier, tester and buyer?
- Is an ASTM or ISO standard specification for human implant clearly indicated?
- Is the quantity and size of the material described on the certificate?
- Is the quantity and size sufficient to make the jewelry related to this certificate?
At an ASTM F04-12 meeting, part of the concern for validation was given a concrete example by the FDA representative:
There was a big scandal that the FDA had to deal with involving unsafe nonconforming imported titanium marked as F136 from China. It didn’t meet all the test criteria. It made its way into implants, which later failed and caused harm. That was just raw material purchased from China, the manufacturing was done in the US. For items wholly produced outside of the US it seems for reliability, unless there is someone on site to validate QC to international standards, there is very little that we can do to maintain that a jeweler does use what is on a certificate, or that the certificate is accurate. The main issue with foreign certificates for USA buyers is that they are not under FDA jurisdiction, so they could be falsified with no legal repercussions.
A few suggestions:
- Independent metallurgical testing can be done on the raw material prior to production, and on random samples of the jewelry production.
- Nondestructive chemistry testing is simpler than ever now with Xray fluoroscopy (XRF) devices.
- Surface smoothness profiling with a non-contact profilometer is also accessible and a good reference for your buyers.
- On the other hand, microstructure testing tends to be destructive and more complicated to have done.
- The certification from those sample tests would not be from the mill/supplier but should be from an independent third party.
- Consider third party validation to ASTM test specifications.
- Avoid the description “implant-grade” and simply describe the product as meeting current ASTM surgical implant standard F136, for example.
The Association of Professional Piercers agreed upon minimum standards for body jewelry.
Certification of tests that specify a material is suited for human implant purposes is an important part of validating the safe use for body jewelry. There are some historical jewelry materials exceptions such as gold and glass which the APP has allowed based on extensive review, and further particular examples are described below.
EEC Nickel Directive information
In reference to the EEC Nickel Directive, this regulation does not specify or prove that a material is safe for short or long term wear in contact with the body. It only requires a low rate of nickel release for all material used for costume or fine jewelry, belt buckles, watches or other metallic accessories with skin contact.
Do you have an example certificate to review?
Send them to me here: firstname.lastname@example.org