# Proposal for National Review Committee for

Dental Amalgam Separators

DRAFT 3

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Introduction:

The N ational R eview C ommittee for dental amalgam separators is intended to serve the regulatory community (local,

state, and national jurisdictions ) in ad ministering their amalgam separator installation and maintenance programs. Most

programs require or recommend the installation of amalgam separators that have undergone and passed ISO 11143

testing. ISO 11143 is a bench

- top test procedure that is conducted to determine if the separator meets several

requirements , including a 95% removal requirement for amalgam particles in wastewater. Some jurisdictions in the US

require higher percent removal rates, such as 98% or 99%.) ISO refers to the International Orga nization for

Standardization.

To avoid duplication of effort and the need for each jurisdiction to become experts on ISO testing and amalgam separator

evaluation, it would be desirable if th ese function s could be streamlined and centralized. With a core g roup of persons

knowledgeable in ISO testing methods and materials, individual jurisdictions can rely on the expertise of the core group

and do not have to become experts themselves.

Therefore, it is recommended that a National Review Committee be conven ed to assist in the review of amalgam separator

test reports issued to separator manufacturers. When a manufacturer has their separator tested by a n accredited testing

laboratory, a test report is issued. This completes the initial step in what is called t he “Conformity Assessment Process”.

While ISO s tandards are formal and regimented, following the Conformity Assessment Process is voluntary. Therefore, it

is up to the regulatory community to recognize and call for the implementation and use of the Conform ity Assessment

Process tools

.

The next step in the Conformity Assessment Process is the “certification” of the separator. Certification is a quality

control process whereby the manufacture r enters into an agreement with the issuer of the certificate, whic h is a “certification body”. As part of this agreement, the manufacture r is obligated to inform the certification body of

modifications to the tested separator. The purpose of the certification, and the ongoing quality control process, is to ensure

that th e separator sold today is the same as the model that ha s undergone and passed the initial ISO testing. Once certified,

the certification body allows the manufacture r to “Mark” its product (and sales literature) with the certification body’s

logo or some ph rase indicating that it has passed testing for the ISO 11143 standard and a quality control process is in

place. The National Review Committee would also review certificates issued to separator manufacturers.

The final

, key tool in the Conformity Assessme nt Process is accreditation. Testing laboratories and certification bodies

may be accredited. This leads to the question as to who is the accreditor? As part of the Conformity Assessment Process,

the accreditors may be signatories to their respective inter national “Arrangement”. If so, this helps ensure procedures are

followed with the goal of “Certified once, accepted everywhere”, for global trade. Also, as part of the accreditation

process, the “scope of accreditation” for each of the testing laboratories may specifically identify ISO 11143 as a standard

that the lab has been recognized as being capable of performing.

As noted above, all of these Conformity Assessment Process tools exist, but they are not automatically applied or

employed. The regulatory community needs to be proactive in terms of taking advantage of these tools. By doing so, there

will be a significantly reduced burden on the regulators in administering amalgam separator installation programs. A

National Review Committee can be the link b etween all of the various local, state, and national jurisdictions and the

Conformity Assessment Process. This will ensure a fair, and well administered separator installation program as

regulators shift from administering programs based on meeting concent ration limits to compliance being based on dental

clinics selecting and installing an amalgam separator from a list of approved amalgam separators (see Item 3, below)

.The N ational Review C ommittee will :

(1) Determine from which testing laboratories and cer tification bodies reports and certificates will be considered for

review. (This determination is based on the accreditation of the labs and certification bodies.)

(2) R eview test reports and certificates submitted by amalgam separator manufacturers.

(3) Provide a finding of either: “ Satisfactory ” or “Unsatisfactory ” and the issuance of a certificate to the amalgam

separator manufacturer

. A separator must pass ISO 11143 to achieve a finding of “ Satisfactory ”. The test report

should indicate if the separator model passes the ISO 11143 requirements, or not , according to the lab

. A “S atisfactory” finding by the Review Committee indicates concurrence with the laboratory.

(The Review Committee will leave it up to individual regulatory jurisdictions to approve, or disap prove, of the

separator models based on their own approval criteria, such as requiring a higher percent removal efficiency .)

(4) P rovide a listing of amalgam separator specifications in the table below

.

(5) If the ISO Standard is revised , or if the American Nati onal Standards Institute (ANSI, the US’ member to ISO)

adopts or modifies the ISO Standard , the Review Committee will take all of this into consideration and determine

if any action should be taken regarding the procedures outlined above . Possible examples include, (but are not

limited too) : continuing with the current ISO or ANSI standard, adopting the revised ISO or ANSI standard,

requiring that separator models be retested and/or recertified.

Testing Laboratories and Certification Bodies Qualifying Cri teria :

The National Review Committee will review test reports and certificates from only the following:

Testing labs that have been accredited by an accreditation body that is a signatory to the International Laboratory

Accreditation Cooperation’s Mutual Recognition Arrangement (see: www.ilac.org ). The testing lab’s scope of

accreditation must include ISO 11143.

Certification bodies that have been accredited by an accreditation body that is a signatory to the Internati onal

Accreditation Forum’s Multilateral Recognition Arrangement (see: www.iaf.nu ).

Testing laboratories and certification bodies that meet the above qualifying criteria:

SP Technical Research Institute of Sweden

Borås, S weden

NSF International

Ann Arbor

, Michigan

Each of these facilities operates both a testing lab and a certification body.



### AMALGAM SEPARATOR LAB TESTING AND

CERTIFICATION EVALUATION RESULTS

Manufacturer

Separator model name/number

Review Committee findings (Satisfactory / Unsatisfactory)

Testing laboratory

Passes basic ISO requirements according to lab (Yes / No)

Test report dateTest report number

Certification Body

Certificate issued (Yes / No)

Certificate dat e

Certificate number

Certificate expiration date

Max imum flow rate (liters/minute)

Sep arator eff

iciency

, (percent)

Average of three empty test runs

Separator efficiency

, (percent)

Ave rage of three sim

ulated full test runs

Lesser of two ave rage s (either empty or full, percent)

[≥95% to pass ISO 11143]

Overall ave rage of 3 empty and 3 simulated full (percent)

(i.e., average of the total 6 test runs)

Notes or comments