Q&A: ISO 11143: Amalgam Separators

  • Open What is amalgam?

    Dental amalgam is a durable material used to restore teeth. It consists of a mixture of metals including silver, copper and tin, in addition to mercury, which binds these components into a hard, stable substance. Dental amalgam is one of several restorative materials available to dentists and patients.

  • Open What is an amalgam separator?

    An amalgam separator is a device that removes amalgam particles from the wastewater of a dental treatment center to reduce the number of amalgam particles and, therefore, the amount of amalgam entering the sewage system.

  • Open Why is amalgam not safe for the environment?

    When dental amalgam enters the environment, the mercury can be released due to the high temperatures used during the incineration process of municipal garbage, medical waste and sludge at wastewater treatment plants. Mercury in the environment is bioaccumulative, which means that it can build up in fish and cause health problems in humans and other animals that eat fish.

  • Open What is the process for NSF certification to ISO 11143?

    The NSF certification process to ISO 11143 includes the following:

    • Detailed review of all treatment system components, including suppliers of each component and trade name.
    • Testing to ISO 11143 to determine compliance to the requirements of the standard.
    • Annual audit at the manufacturing facility to ensure ongoing compliance with all requirements of ISO 11143 and NSF certification policies.
  • Open What are the advantages of NSF certification of an amalgam separator?

    Certification of an amalgam separator assures dental office staff, dental patients and regulators that the device bearing the NSF mark meets the requirements of ISO 11143. NSF policies require manufacturers to gain approval for any modification to a previously certified device. NSF annual manufacturing plant audits verify that the manufactured product meets the specifications of the product as certified, and that no unauthorized changes have been made to the certified device.