Mich. Admin. Code R. 338.11813 - Amalgam separator; requirements
Rule 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.
(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 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.
Notes
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