How to relate a certificate of tests (Mill Certificate) to an appropriate standard

How to relate a certificate of tests (Mill Certificate) to an appropriate standard

ASTM member and Logo certification

Questions you can use to determine if a body jewelry material is tested to relate to an appropriate standard specification

  1. Is contact information available for the supplier, tester and buyer?
  2. Is an ASTM or ISO standard specification for human implant clearly indicated?
  3. Is the quantity and size of the material described on the certificate?
  4. Is the quantity and size sufficient to make the jewelry related to this certificate?
  5. Is the material source within your legal jurisdiction?

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.

Minimum standards

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.

Read more at the APP website.

The revised Minimum Standard for Jewelry for Initial Piercings is as follows:

[Revised 04/04/2017 to include rose gold]

  • Steel that is ASTM F138 compliant or ISO 5832-1 compliant
  • Steel that is ISO 10993-6, 10993-10, and/or 10993-11 compliant
    • [Note: The EEC Nickel Directive is a regulation that requires a low rate of nickel release for all materials used for costume or fine jewelry, belt buckles, watches, or other metallic accessories with direct skin contact. It does not specify nor prove that a material is safe to wear in the body; therefore, compliance with this directive alone is not sufficient for meeting the APP initial jewelry standards.]
  • Titanium (Ti6Al4V ELI) that is ASTM F136 compliant or ISO 5832-3 compliant
  • Titanium that is ASTM F67 compliant
  • Solid 14 karat or higher nickel and cadmium free yellow, white, or rose gold
  • Solid nickel-free platinum alloy
  • Niobium (Nb)
  • Fused quartz glass, lead-free borosilicate or lead-free soda-lime glass
  • Polymers (plastics) as follows:
    • Any plastic material that is ISO 10993-6, 10993-10 and/or 10993-11 compliant and/or meets the United States Pharmacopeia (USP) Class VI material classification.
    • Tygon® Medical Surgical Tubing ND 100-65 or ND 100-80
    • Polytetrafluoroethylene (PTFE) that is ASTM F754 compliant
  • All threaded or press-fit jewelry must have internal tapping (no threads on posts).
  • For body jewelry purposes, surfaces and ends must be smooth, free of nicks, scratches, burrs, polishing compounds and metals must have a consistent mirror finish.

This revised wording will be used on all future APP publications and correspondence where the earlier version of the standards was published.

Adopted February 05, 2009 [Revised April 04, 2017 to include rose gold]

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:

4 thoughts on “How to relate a certificate of tests (Mill Certificate) to an appropriate standard”

  1. I agree with you. Gold plated, gold-filled jewelry is not acceptable for fresh piercings. We must remember that choosing jewelry for a new piercing is completely different from shopping for a ring to wear or a bracelet to wear.

    • The important thing to express to the customer is either it has been tested for the body, or not. The ASTM specifications for surgical implant qualify a material for safe use. Otherwise it is just someone\’s opinion.

  2. Very Interesting , It is nice to see that these are being adhered to, I have always been told that people only use surgical steel for new piercings .. I never really thought about this though .. now I understand

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