Section 338.11813. Amalgam separator; requirements.

Rule 1813. (1)  An amalgam separator that is installed in a dental office under R 338.11811 shall meet all of the following requirements:

(a)        Be certified as passing the international organization for standardization (iso) 11143:2008 standard 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 any of the following:

(i)     SP technical research institute of Sweden.

(ii)     Tuv nord, Germany.

(iii)     NSF international.

(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.

(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.

(2)  Any amalgam separator that meets the requirements of subrule (1) of this rule shall qualify as an amalgam separator approved by the board.

History: 2012 AACS.