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Questions & Answers Amalgam Separators and ISO 11143

NSF International, The Public Health and Safety CompanyTM, was recently accredited by the International Accreditation Services (IAS) to test to International Organization for Standardization (ISO) 11143: Dental EquipmentAmalgam Separators. Following extensive testing and a comprehensive audit, NSF has issued the first certification under ISO 11143 to Dental Recycling North America (DRNA) for its DRNA BU10 Amalgam Separator. The following information explains the importance of the ISO 11143 Standard and the NSF Certification process.

Q: What is amalgam? A: Dental amalgam is a durable material that has been used to restore the teeth of more than 100 million Americans, according to the American Dental Association (ADA). It is comprised of a mixture of metals that includes 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. Q: What is an amalgam separator? A: An amalgam separator is designed to remove 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. Q: How does an amalgam separator work? A: According to ISO 11143, amalgam separators are classified as one of four types. Each type, detailed in the table below, utilizes a different type of technology to remove the amalgam particles.

Type of System

Type 1: Centrifugal system

Method

These systems use centrifugal force to draw out amalgam particles from the wastewater. These systems reduce the speed of wastewater flow, which allows amalgam particles to settle out of the wastewater. Depending on the type of filter used, these separators remove not only coarser amalgam particles but also some finer and colloidal amalgam particles. These separators use any combination of two or more technologies to remove minute amalgam particles and dissolved mercury particles.

Type 2: Sedimentation system

Type 3: Filter system

Type 4: Any combination of types 1, 2 and 3

Q: Why is amalgam not safe for the environment? A: 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 from 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. Q: Who is ISO? What does ISO do? A: ISO (International Organization for Standardization), a non-governmental organization, is a network of the national standards institutes of 157 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is the world's largest developer and publisher of international standards. For more information on ISO, please visit www.iso.org. Q: What is ISO 11143? What requirements are included in ISO 11143? A: ISO 11143 is a standard developed by ISO that provides specific requirements and test methods for amalgam separators, first issued in December 1999. The standard specifies the efficiency of the amalgam separators and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the separator, marking, instructions for use, operation and maintenance. Q: What does NSF have to do with amalgam separators? A: As an accredited conformity assessment body, NSF tests thousands of different products to the requirements of national and international standards. In this case, NSF evaluates separators against the requirements of ISO 11143 and issues an NSF Certification that the separator meets the requirements of the ISO Standard and the client adheres to all NSF Policies. The NSF Mark demonstrates compliance with all ISO 11143 requirements. Q: What does NSF Certification to ISO 11143 entail? A: The certification process to ISO 11143 includes the following: · Detailed review of all components used to manufacture end units, including supplier of each component and trade name. · Testing to ISO 11143 performed by NSF to determine compliance to the requirements of the standard. · Annual audit performed by an NSF auditor at the manufacturing facility to ensure ongoing compliance with all requirements of ISO 11143 and NSF Certification policies. Q: What are the advantages of NSF Certification of an amalgam separator? A: Certification of an amalgam separator provides assurance to a user or regulator that the device bearing the NSF Mark meets the requirements of ISO 11143. NSF policies require manufacturers to gain approval for any modification of the certified device that was tested. NSF assures this by completing annual manufacturing plant audits to verify that no changes have been made to the certified device.

Q: How long has NSF been offering certification services? Who makes sure NSF is doing its job? A: Since 1944, NSF has developed over 50 standards and protocols. NSF tests and certifies over 225,000 products in 100 countries. NSF's standards development process is accredited by the American National Standards Institute (ANSI) and the company is also accredited by the International Accreditation Service (IAS), and the Standards Council of Canada (SCC), among others. NSF has been testing amalgam separators since 2006 and has recently initiated a certification program for these devices. Q: How can a company verify compliance with ISO 11143? A: Look for the NSF Mark displayed prominently on the product, as well as in the sales/marketing information and user guides. Also, be sure to visit NSF's Listings page at: www.nsf.org/info/listings. Certifications to ISO 11143 appear under the Wastewater Listings page on the NSF web site at www.nsf.org/Certified/Wastewater. Certified to ISO 11143 Q: Who is NSF International? A: NSF International, formerly the National Sanitation Foundation, is an independent, not-for-profit standards development, testing and certification organization. For over 60 years, NSF's mission has been to protect and improve public health. Headquartered in Ann Arbor, Michigan, NSF has offices throughout Europe, Asia, North and South America. NSF recently certified the first amalgam separator ­ the DRNA BU10 ­ to ISO 11143. Q: Who is DRNA? A: Dental Recycling North America (DRNA) is a North American leader in dental waste management and recycling (www.drna.com). From amalgam waste solutions to used x-ray chemistry waste solutions, DRNA provides the essential and affordable services for dental offices. DRNA has a long history of serving the dental community with a commitment to excellence.

NSF International

789 N. Dixboro Road · Ann Arbor, MI 48105 1-800-NSF-MARK or 734-769-8010 p · 734-769-0109 f www.nsf.org · [email protected]

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