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Administration of the List of Approved Amalgam Separators

Metropolitan Council Environmental Services & Minnesota Dental Association 

August 24, 2004

Introduction

The purpose of this document is to describe the procedure for adding an amalgam separator to the List of 

Approved Separators that is part of the Voluntary Amalgam Recovery Program. This program is being jointly 

implemented by Metropolitan Council Environmental Services (MCES) and the Minnesota Dental Association 

(MDA). The List of Approved Separators is administered by the Steering Committee, which is comprised of 

representatives from MCES and the MDA. 

Policy

In order to be included on the MCES/MDA Steering Committee’s list of approved amalgam separators:

New amalgam separator models must be tested according to the ISO 11143 Standard and obtain a laboratory 

test report and a certificate;

Amalgam separator models, whose collecting container has been modified in a manner that may reduce the 

removal efficiency of the unit, must be retested according to ISO 11143 and obtain a laboratory test report 

and a certificate;

Separators must remove at least 99% of the amalgam, as tested according to ISO 11143 (based on the 

average of the data for testing under empty and simulated full conditions).

The manufacturer/distributor of an amalgam separator on the Approved List must inform the MCES/MDA 

Steering Committee when any changes are made to their separators prior to marketing the modified separators. 

Lack of disclosure may expose the manufacturer to sanctions as determined by the Steering Committee.

In the case of modifications to auxiliary components of an amalgam separator, for those models where the 

auxiliary components were part of the initial ISO 11143 testing, ISO 11143 retesting will not be required if the 

following criteria are met:

The collecting container of the separator, which treats the wastewater, remains unchanged, and 

Modifications to any auxiliary component do not reduce the separator’s amalgam removal efficiency.

The addition or modification of an auxiliary component that may affect or regulate the flow (such as a “flow 

restrictor”) will not result in the need for ISO retesting. However, hydraulic testing will be required in order to 

verify that the flow does not exceed the flow conditions present during ISO 11143 testing. (See Appendix A.) 

Examples of modifications that may affect the flow through a separator include (but are not limited to): addition 

of a flow restrictor, modification of a flow restrictor, changes to the volume or dimensions of a surge tank, and 

modifications of internal connections or plumbing within a separator.

This policy section notwithstanding, the Steering Committee may require ISO 11143 retesting if it has specific 

concerns about an amalgam separator or if its ability to perform at its originally tested removal efficiency is 

uncertain.

File: Hg-Amalg Rec Prog, Sep Model Review Criteria 8-04 (V-drive, Reformatted March 16, 2005)
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Issuance and Acceptance of Laboratory Test Reports and Certificates

Laboratory test reports and certificates issued for the ISO 11143 Standard will be accepted only from testing 

labs and certification bodies approved and listed by the Steering Committee. Currently, those listed are 

RWTÜV (Germany) and SP Swedish National Testing and Research Institute (Sweden). Additional testing 

laboratories and certification bodies may be added by the Steering Committee if these laboratories or 

certification bodies are each accredited and their scope of accreditation includes the ISO 11143 Standard.

Glossary

Accredited Certification Body: An organization that is accredited (e.g., by ANSI in the United States or 

SWEDAC in Sweden) to issue certificates.

Amalgam separator: The collecting container, any auxiliary component (e.g., surge tank), and internal 

connecting plumbing or fixtures between the collecting container and the auxiliary component(s).

Auxiliary component: A part of the amalgam separator that is not part of the collecting container, but is 

marketed as part of the separator. This does not include basic fittings added by a plumber for the purpose of 

installing the separator. (Plumbers are not to modify the inner workings of a separator.)

Certificate: A document issued by a “certification body” which confirms that the separator passed all of the 

requirements of ISO 11143 and sets up a quality control system between the certification body and the 

separator manufacturer. A certificate assures continuity in the manufacturing of separators that conform to 

the requirements of the ISO Standard. A certificate is obtained in addition to the laboratory test report. The 

certificate must be issued by an accredited certification body (accredited by ANSI if located in the United 

States). See section above on Issuance and Acceptance of Laboratory Test Reports and Certificates. 

Collecting container: That part of the amalgam separator performing the treatment and removal of amalgam 

waste solids (and in some models, dissolved mercury) from the wastewater. 

Flowrate: Rate at which wastewater passes through the amalgam separator for flow-through models, or the 

rate at which the amalgam separator is decanted for batch-treatment models (expressed in liters/minute or 

milliliters/minute).

Modified model: The model that is similar, and based on, the original model. In the modified model, the 

collecting container, or one or more of the auxiliary component(s) that were part of the ISO testing of the 

original model, have been altered.

Original model: That model that was tested according to ISO 11143 and approved and listed by the 

MCES/MDA Steering Committee.

Pressure head: The height of wastewater above the collecting container.

Settling time: The amount of time to treat the wastewater via settling.

Steering Committee: The committee comprised of representatives from MCES and the MDA that developed 

and oversee the implementation of the Voluntary Amalgam Recovery Program.

Procedure

The steps to be taken by the manufacturer/distributor and the MCES/MDA Steering Committee are outlined 

below and illustrated in a “Decision Tree”, see Appendix B, on page 7:

A. The amalgam separator manufacturer/distributor submits a request to add a new or a modified model to the 

MCES/MDA list of approved separators. The submittal should include all information necessary to 

complete the “Features” table shown in the “re: amalgam recovery” booklet and on the MDA website 

showing updated information. For new models, the submittal must include the test report and certificate.
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In the case of modified models, the manufacturer must also put together a submittal addressing the 

following points:

1. State the name of the modified model.

2. Describe the nature and location of all modifications and how these modifications may affect the 

performance of the separator. The description of the modification location shall specify if the 

modification was made to the collecting container or to the auxiliary components of the separator. 

Changes to the collecting container will trigger a requirement for retesting according to ISO 11143.

3. Describe any effect the changes will have on the pressure head, flowrate, the settling time, or any other 

performance factor of the modified model.

4. Explain any operational changes (operation & maintenance) that the dental clinic staff will have to 

implement to ensure that the modified model will perform at least as well as the original model.

5. Declare whether the model will achieve at least the same level of treatment (amalgam removal) as the 

original model and provide information (such as engineering or hydraulic information) to support this 

claim (see “Supporting Information” on page 3).

6. Give the specifications for the “Features” table and note any changes to the specifications as compared 

to the original model.

The required information shall be submitted to both Loren Hanson at the MDA and Peter Berglund at 

MCES. (See complete contact information on page 4.)

B. The MCES/MDA steering committee will review the information submitted by the manufacturer/distributor, 

as described in Part A above. A determination will be made to either:

1. Approve the new, or modified, amalgam separator model;

2. Inform the manufacturer/distributor that an approval cannot be made, and allow the 

manufacturer/distributor an opportunity to submit additional information; or

3. Inform the manufacturer/distributor that an approval cannot be granted without the submittal of a test 

report and a certificate for ISO 11143 testing.

Supporting Information

In the case of a manufacturer/distributor claiming that the modified separator model will perform at least as well 

as their original model in terms of amalgam removal, it is up to the manufacturer/distributor to submit 

information to support their claim. The manufacturer/distributor is responsible for considering all factors that 

may affect the performance of their modified model. Independent testing may be required to verify the 

information and data submitted by the manufacturer/distributor.

The following are examples of types of engineering or other information that the manufacturer/distributor could 

submit as part of their supporting documentation:

Dimensions of the separator model and any auxiliary components

Hydraulic test results with data on pressure, flowrate, or settling time. (See Appendix A.)
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Timeline

Within two weeks of receipt of a request, the steering committee will notify the manufacturer/distributor to 

confirm that the request has been received.

If additional information is required in order for the request to be evaluated, the steering committee will notify 

the manufacturer/distributor within two months to explain what additional information must be submitted.

Upon receipt of all necessary information, the steering committee will evaluate the request and within two 

months either:

Approve the new or modified separator model and add it to the approved list, or

Deny the request for addition to the list and inform the manufacturer/distributor of the reason for denial. The 

denial letter shall indicate that ISO 11143 testing and a certificate will be required prior to any further 

consideration of the model for addition to the Approved List.

Contact Information for the MCES/MDA Steering Committee

The points of contact for the MCES/MDA Steering Committee are: 

Mr. Loren Hanson Mr. Peter Berglund, P.E.

Minnesota Dental Association Metropolitan Council Environmental Services

2236 Marshall Avenue Industrial Waste & Pollution Prevention Section

Suite 200 230 East 5th Street

St. Paul, MN 55104 St. Paul, MN 55101

651-646-7454 651-602-4708

lhanson@mndental.org peter.berglund@metc.state.mn.us

Unless directed otherwise, submittals to the Steering Committee should be made in duplicate, with one copy 

going to the MDA and one copy going to MCES.

Website information for the MCES/MDA Amalgam Recovery Program is maintained by the MDA at:

www.mndental.org (click on “Dental Professionals” on the left side of the homepage)
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Appendix A

Hydraulic Testing of Amalgam Separators

As described in the Policy section of the document Administration of the List of Approved Amalgam Separators

by Metropolitan Council Environmental Services & the Minnesota Dental Association:

“The addition or modification of an auxiliary component that may affect or regulate the flow (such as a “flow 

restrictor”) will not result in the need for ISO retesting. However, hydraulic testing will be required in order to 

verify that the flow does not exceed the flow conditions present during ISO 11143 testing. Examples of 

modifications that may affect the flow through a separator include (but are not limited to): addition of a flow 

restrictor, modification of a flow restrictor, changes to the volume or dimensions of a surge tank, and 

modifications of internal connections or plumbing within a separator.” 

Appendix A is intended to give instructions to amalgam separator manufacturers/distributors and testing 

laboratories on conducting hydraulic testing of separators.

Basic instructions:

Present this document to the testing laboratory. 

Hydraulic testing should be conducted to test the “worst case scenario” of flow through the amalgam separator 

since ISO calls for testing at the “maximum flowrate”. Therefore, water shall be run into the surge tank of the 

separator at a rate that will result in the surge tank being filled and continuously overflowing at the top, thereby 

maintaining a steady-state condition. (The overflowing excess water should be routed away from the separator, 

such as to a drain.)

The water flowrate passing through the collecting container of the separator is to be measured and reported. The 

testing laboratory should include with its report:

1. Amalgam separator model name/number.

2. Flowrate exiting the collecting container of the amalgam separator 

(expressed in milliliters/minute or liters/minute).

3. Photograph or a diagram of the test setup.

4. Volume of the surge tank.

5. Dimensions of the surge tank.

6. Volume of the collecting container

(volume of the cavity space, with whatever media/baffles are present inside).

7. Dimensions of the collecting container.

8. Serial number of the amalgam separator 

(i.e., the main separator component which includes the surge tank).

9. Serial number of the collecting container.

10. Standard conditions normally recorded as present during the hydraulic testing

(water temperature, ambient room air temperature, ambient air humidity, and barometric pressure).
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Choosing and contracting with a hydraulic testing laboratory:

The manufacturer/distributor must contract with an independent hydraulic testing laboratory. [Note that the 

hydraulic testing laboratory may be different from the ISO 11143 testing laboratory.] The laboratory must be 

accredited by an accreditation body which is a “signatory to the International Laboratory Accreditation 

Cooperation’s Mutual Recognition Arrangement” (ILAC MRA). Examples of such accreditation bodies are the 

American Association for Laboratory Accreditation (A2LA) and the National Voluntary Laboratory 

Accreditation Program (NVLAP).

The laboratory’s scope of accredited services must include flow measuring of fluids, such as water.

Submittal of report and letter by the separator manufacture/distributor:

The separator manufacturer/distributor shall include with its submittal to the MCES/MDA Steering Committee, 

the hydraulic test report along with a signed letter stating that:

“The amalgam separator model (name/number) tested by (hydraulic testing lab name) is representative of the 

separator model being requested for inclusion on the MCES/MDA list of approved separators.”
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New Separator Model

Is the separator a new model?

Yes

No

Submit the separator to a testing laboratory (accepted by 

the Steering Committee) to be tested according to ISO 

11143 and obtain a test report and a certificate. As 

described in Part A of the Procedure Section, the test 

report, certificate, and “Features” table information shall 

be submitted to the Steering Committee for 

consideration. The Steering Committee will then follow 

Part B of the Procedure.

Modified Separator Model

Have modifications been made to the separator?

Yes No

Has the name and/or 

model number of the 

separator changed?

The manufacturer shall follow Part 

A of the Procedure, and submit its 

information to the Steering 

Committee. The Steering 

Committee will then follow Part B 

of the Procedure.

The manufacturer shall follow Part A of the Procedure, explaining in 

its submittal that the separator has not been altered, only renamed. The 

Steering Committee will then follow Part B of the Procedure.

.

Yes

Appendix B Decision Tree

This Decision Tree is designed to assist the reader in navigating the application process to list an approved separator.