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

Questions you can use to determine if a body jewelry material is tested to conform 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 or part of the DFARS agreement?

At an ASTM F04-12 subcommittee meeting, part of the concern for validation was given a concrete example by an 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 for raw material purchased from China, the manufacturing was done in the USA.

For items wholly produced outside of the USA it seems for reliability, unless the country is part of the DFARS agreement, and 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 buyers is that they are not under their (FDA or equivalent) jurisdiction, so they could be substandard or falsified with no legal repercussions.

Here are examples of how steel and titanium are produced by a mill and this explains how the continuous testing is done and documented on certificates.

Note how many steps are analysed and recorded for purity and conformity to a standard specification. Also note how many variables there are which could result in products with similar chemistry but different microstructure or impurities.

This is how stainless steel alloys are made and tested for certification of conformity. ASTM F138 explains more
This is how commercially pure unalloyed Titanium is made. ASTM F67 explains more.
Here is my Biomaterials playlist with more about making safe materials for the body.

A few suggestions:

There does not appear that much can be done to prove that materials made outside the DFARS agreement conform to the quality standards of ISO/ASTM specification, without destructive testing and remelting. Since the bar and wire used to make body jewelry could be out of specification in the middle or anywhere else along the length, testing random samples from the surface or ends of the bar is not enough. A strict process control is required at the mill during production to ensure conformity and reduce interstitial impurities.

  • For additional reassurance, independent metallurgical testing can be done on the raw material prior to jewelry production, and on random samples of the jewelry production, but this does not tell us everything we need to know.
    • Nondestructive chemistry testing for ASTM F2999 and F2923 can begin with High Definition Xray Fluoroscopy (HDXRF) devices to detect harmful surface levels of elements such as cadmium, lead, and nickel. Hard pass if these are found.
    • Surface smoothness profiling with a non-contact profilometer is also accessible and a good reference for your buyers.
    • Microstructure testing tends to be destructive, and is best provided as part of the process control certificate of tests from the material producer.
  • 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 ISO/ASTM test specifications.
  • Avoid the description “implant-grade” and simply describe the product as meeting current ASTM surgical implant standard F136, for example.
HDXRF can be a first step to rule out toxic or sensitizing chemicals at the surface of materials

Minimum standards to reduce risk of reaction

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 as exceptions such as gold and glass which the APP has allowed based on extensive review, and further particular examples are described below.

Association of Professional Piercers (APP) Initial Jewelry Standards

The revised minimum standard for jewelry for initial piercing is as follows:

  1. Any and all materials that meet ASTM and/or ISO standards for implantation.
    Examples of these include, but are not limited to:
    1. Steel that is ASTM F138 compliant or ISO 5832-1 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.]
    2. Steel that is ISO 10993-6, 10993-10 and/or 10993-11 compliant
    3. Unalloyed titanium that is ASTM F67 or ISO 5832-2  compliant
    4. Alloyed Titanium (Ti6Al4V ELI) that is ASTM F136 compliant or ISO 5832-3 compliant
    5. Alloyed Titanium  (Ti6Al7Nb ELI) that is ASTM F1295 compliant or  ISO 5832-11 compliant
    6. Polytetrafluoroethylene (PTFE) that is ASTM F754 compliant
    7. Any polymer or 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. 
  2. Solid 14 karat or higher yellow, white, or rose gold that is nickel and cadmium free. Gold jewelry used for initial piercing may not be:
    1. Plated, unless with materials approved by this standard, including yellow, white, and rose gold that is 14k or higher, or white rhodium.
    2. Gold-filled
    3. Gold overlay/vermeil
  3. Solid unalloyed or alloyed platinum that is cadmium, nickel, and lead free.
  4. Unalloyed Niobium (Nb) that is ASTM B392 compliant. This includes but is not limited to:
    1. commercial grade 2 Niobium
    2. commercial grade 4 Niobium that contains 1% Zirconium 
  5.  Glass that is lead free. This includes, but is not limited to:
    1. Fused quartz
    2. Borosilicate
    3. Soda-lime
  6. All threaded or press-fit jewelry must have internal tapping (no threads on exterior of posts and barbells).
  7. For body jewelry purposes, surfaces and ends must be smooth and free of nicks, scratches, burrs, stamps, hallmarks, polishing compounds, and other potentially harmful residues.
  8. Metals must have a consistent mirror finish on surfaces that frequently come in contact with tissue.
  9. All jewelry used for initial piercing on people above the age of 12 must be ASTM F2999 compliant
  10. All jewelry used for initial piercing on people ages 12 and under must be ASTM F2923 compliant

Adopted February 05, 2009 [Most recent revision approved: 05/28/2019]

The APP Board of Directors has adopted a revision to the APP minimum membership standards for jewelry for initial piercings. Although a Members’ vote was taken to adopt the original standards, a membership vote is not required when establishing or revising membership requirements. The Board has opted to proceed without member polling for the following reasons:

  1. This revision simply updates and expands the standards set forth in the original document.
  2. The new revised standards better reflect the current practices of both the APP membership and the piercing industry at large.
  3. The APP has had extensive communication—both in person and in writing—from piercers questioning the out-dated and confusing nature of the previous standards.
  4. Regulatory agencies often utilize the APP standards and incorporate them into law. Maintaining the outdated standards can therefore have negative consequences for piercers using acceptable products that were previously not listed.

The practice of relying solely on the implant designation of a material has now been addressed. Although implant standards address biocompatibility of a given material when used for surgical implants, they may not always be directly applied to the use or required finish for body jewelry. Agencies that determine these designations and standards do so for both material quality and end usage and separate standards are required for surface finish. Implants may rest permanently against internal tissue unless surgically removed or replaced, and are sometimes designed for bone or tissue adhesion.  Healing piercings, however, form tissue against the smooth non-adhesive surface of the jewelry, and this jewelry can be changed when appropriate. For these reasons we list conformity to a specification as it applies to material content only; the surface finish requirements are described separately.

Products with an ISO or ASTM designation are so noted and a statement specifying the finish requirements particular to body jewelry has been added. In addition, several common jewelry materials designated for applications other than implants have been proven through historical and practical application to be suitably biocompatible for initial piercing.

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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