The APP’s Initial Jewelry Standard allows for jewelry that is made from any material that meets ASTM and/or ISO standards for the manufacture of surgical implants. Mill certificates are used in determining compliance with these standards.
The information cited below is a simple representation of mill certificate criteria, for manufacturer Technical specs please contact medical@safepiercing.org
What is a Mill Certificate?
A mill certificate is a quality assurance document used in the metals industry to quantify the chemical and physical properties of a material. It states that a product made of metal (titanium, steel, aluminum, brass, or other alloys) complies with the specifications of the order. It provides test results to assure compliance with the specified standards. The standards for biomaterials are specified by international organizations including ASTM and ISO and may be referred to by national standards bodies such as ANSI for trade and regulatory purposes. Typically, mill certificates are formatted to conform with the EN 10204 standards as well.¹ Some of the other names for mill certificates include:
- material test report (MTR)
- mill test report
- certified material test report
- mill test certificate (MTC)
Where do I get a Mill Certificate?
Upon request, any company producing jewelry must provide a copy of the certificate(s) obtained from the foundry where their raw material was purchased. If a jewelry manufacturer is unwilling or unable to produce this certification, their jewelry materials cannot be presumed to meet ASTM or ISO specifications based on their assertion.
The mill certificates should not be altered. Some jewelry companies do not want to disclose their sources or distributors whose names might be on the material certificate. In that case, they need to go through a third-party inspection verification company with a non-disclosure agreement.
The raw material supplier shall provide such certification to the jewelry company, that the material was tested in accordance with the requested specifications and has met all requirements. This should happen at the time of shipment. The raw material supplier shall maintain a quality program such as defined in ISO 9001.
What’s on a Mill Certificate?
Some or all of the information that may be found on these documents includes:
- Contact information for the supplier, tester, and buyer
- ASTM or ISO standard that relates to human implantation
- Material dimensions include size (gauge) and form (sheet, bar, wire, etc)
- Quantity/Weight
- Finish
- Product Analysis
- Chemical Analysis
- Heat Code/Number
When a jewelry manufacturer machines all of their jewelry out of different sizes of stock, they must have mill certificates that correspond to each thickness and shape of material purchased for jewelry that is sold for use in initial piercings.
For a more comprehensive look at the information that should be included within the certificate/report for materials under this specification, please see the ASTM F620 standard.²
Why is a heat code/number important?
Mill certificates will feature a heat number. This is used as a means of tracking the material back to the batch from which it came for the purpose of quality and consistency. The heat number comes from the final step of the milling process where the source sponge of metal is melted down again in a vacuum to remove trapped gases and impurities under strict quality and regulatory control. This number leads you directly to the original melt which ideally would come from a DFARS approved melt source. These sources have adequate agreed-upon legal requirements for the regulatory controls.
What is an unverifiable Mill Certificate?
Substandard & Falsified Materials
When reviewing mill certificates, there will be a physical location for the mill that produced the material. Make note of the country listed. The World Health Organization has publicly reported that implant grade materials provided by certain countries can’t be verified, as the mills do not follow ASTM, ISO, or WHO criteria.³ ⁴ ⁵
The eligibility criteria for a verifiable mill certificate is based on DFARS Compliance unless documentation provides sufficient information. DFARS compliance for biomaterials producers can be a strong indicator that it will be acceptable for body jewelry as these countries are in agreement with the consequences of substandard and falsified (SF) products. The countries that participate in this quality control agreement are listed on the DFARS 225.003(10).⁶
When the country of the source listed on the certificate is not listed in the DFARS agreement, it can not be verified that the materials were made in accordance with the ASTM or ISO protocols. This is necessary to meet the required ASTM or ISO standards.