ISO 11143: Amalgam Separators

  • Overview
  • Benefits of Certification
  • Why Work With NSF?
  • Certification Process

Dental amalgam is a durable metal mixture that may contain mercury and is used to restore teeth. An amalgam separator removes amalgam particles from the wastewater of a dental treatment center to reduce the number of amalgam particles and, therefore, the amount of amalgam, and potentially mercury, entering the sewage system.

ISO 11143 includes specific requirements for amalgam separators (such as efficiency, safe functioning, marking and instructions for use, operation and maintenance) and defines test methods to determine compliance.

We evaluate amalgam separators against the requirements of ISO 11143 and certify that the separator meets the ISO standard requirements and the customer adheres to all NSF policies. The NSF mark demonstrates compliance with all ISO 11143 requirements.

For more information, contact Sharon Steiner at 734-827-6846 or wastewater@nsf.org.

Benefits of Certification

Certification of an amalgam separator provides assurance to dental office staff, dental patients and regulators that the device bearing the NSF mark meets the requirements of ISO 11143. 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.

Certification also allows your company to:

  • Distinguish your product in the marketplace by demonstrating its performance through independent evaluation
  • List your product and company in our online directory of certified treatment systems
  • Use the NSF certification mark on your systems and in your promotional materials

Why Work With NSF?

NSF International is a leader in testing and certification for the wastewater products and systems market. Products, systems and components that carry the NSF mark are recognized as adhering to the highest standards for quality, performance, safety and protection of the environment. Get the NSF mark on your products and gain the market advantage of certification by one of the most trusted names in the wastewater industry.

Certification Process

The certification process to ISO 11143 includes the following:

Initial Certification

  1. Your company submits an application.
  2. NSF reviews general information, drawings and design specifications of the treatment system.
  3. NSF installs the unit at a test facility and performs thorough testing.
  4. NSF issues a final test report.
  5. NSF reviews product literature, data plates, service labels and related documentation.
  6. NSF performs an initial audit of the manufacturing facility.
  7. Upon gaining certification, your company may use the NSF mark on your product, packaging and promotional materials.

Continued Certification

  1. NSF performs annual audits of the manufacturing facility and in some cases authorized representatives.
  2. NSF reevaluates and potentially retests products at least once every seven years.
  3. NSF reviews and approves any product modifications.

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  • 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.

See all related Q&A

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