Argen is ISO 13485 Certified.
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 130 countries, one from each country. Businesses that implement the international standards developed by ISO meet an international framework for quality management and quality assurance.
ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. Argen supports this international effort.
Argen meets the ISO dental material standards in the Health Care Technology category 11.060.10.
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ISO 1562:1993 |
Dental casting gold alloys |
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ISO 6871-1:1994 |
Dental alloy base metal casting alloys - Part 1: Cobalt-based alloys |
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ISO 6871-2:1994 |
Dental base metal alloys - Part 2: Nickel-based alloys |
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ISO 7405:1997 |
Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials |
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ISO 8891:1998 |
Dental casting alloys with noble metal content of at least 25% but less than 75% |
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ISO 9333:1990 |
Dental brazing materials |
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ISO 9693: 1991 |
Dental ceramic fused to metal restorative materials |
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ISO/FDIS 9693 |
Metal-ceramic dental restorative systems |
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ISO/TR 10271:1993 |
Dentistry - Determination of tarnish and corrosion of metals and alloys |
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ISO/DIS 10271 |
Dental metallic materials - Corrosion test methods |
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