Section R. 338.11813 - Amalgam separator; requirementsRule 1813.
(1) An amalgam separator that is installed in a dental office under R 338.11811 must meet all of the following requirements: (a) Be certified as passing the International Organization for Standardization (ISO) 11143 standard, 2008, for evaluating amalgam separators.(b) Have a removal efficiency of not less than 95% as determined by the testing required under subdivision (a) of this subrule, based on the overall average of the 3 empty and the 3 simulated full test results.(c) Be tested and certified by 1 of the following:(i) SP Technical Research Institute of Sweden.(iv) Both of the following: (A) A testing laboratory accredited by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation's mutual recognition arrangement and has a scope of accreditation that includes ISO 11143 standard, 2008.(B) A certification body accredited by an accreditation body that is a signatory to the International Accreditation Forum's multilateral recognition arrangement and has a scope of accreditation that includes ISO 11143 standard, 2008.(2) Any amalgam separator that meets the requirements of subrule (1) of this rule qualifies as an amalgam separator approved by the board.Mich. Admin. Code R. 338.11813
2012 AACS; 2021 AACS; 2023 MR 19, Eff. 10/2/2023