Dentistry — Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water

ISO/TS 11080:2009 provides guidelines for type test methods for evaluating the effectiveness of treatment methods intended to improve or maintain the microbiological quality of procedural water from dental units and other dental equipment under laboratory conditions.

Art dentaire — Caractéristiques essentielles des méthodes d'essai pour l'évaluation des méthodes de traitement pour améliorer ou maintenir la qualité microbiologique de l'eau procédurale de l'unit dentaire

General Information

Status
Withdrawn
Publication Date
19-May-2009
Withdrawal Date
19-May-2009
Current Stage
9599 - Withdrawal of International Standard
Completion Date
18-Jun-2015
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ISO/TS 11080:2009 - Dentistry -- Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water
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TECHNICAL ISO/TS
SPECIFICATION 11080
First edition
2009-06-01

Dentistry — Essential characteristics
of test methods for the evaluation of
treatment methods intended to improve
or maintain the microbiological quality
of dental unit procedural water
Art dentaire — Caractéristiques essentielles des méthodes d'essai pour
l'évaluation des méthodes de traitement pour améliorer ou maintenir la
qualité microbiologique de l'eau procédurale de l'unit dentaire




Reference number
ISO/TS 11080:2009(E)
©
ISO 2009

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ISO/TS 11080:2009(E)
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ii © ISO 2009 – All rights reserved

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ISO/TS 11080:2009(E)
Contents Page
Foreword .iv
1 Scope .1
2 Normative references.1
3 Terms and definitions .1
4 Dental unit water treatment methods .2
5 Test methods .2
5.1 General .2
5.2 Test methods for evaluating biofilm removal.3
5.3 Test methods for evaluating biofilm prevention or inhibition .4
6 Test apparatus design and operation .5
6.1 Test apparatus design .5
6.2 Test apparatus operation.5
7 Microbiological challenge.5
7.1 Microbiological consortium.5
7.2 Microbiological characteristics.5
8 Chemical characteristics of water used for testing .6
8.1 Water type .6
8.2 Water characteristics .7
9 Microbiological sampling and testing .7
9.1 Sampling.7
9.2 Testing.7
9.3 Corroborative testing .7
9.4 Measures for residual antimicrobial agents .8
10 Test report.8
Bibliography.9

© ISO 2009 – All rights reserved iii

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ISO/TS 11080:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 11080 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.

iv © ISO 2009 – All rights reserved

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TECHNICAL SPECIFICATION ISO/TS 11080:2009(E)

Dentistry — Essential characteristics of test methods
for the evaluation of treatment methods intended to improve
or maintain the microbiological quality of dental unit procedural
water
1 Scope
This Technical Specification provides guidelines for type test methods for evaluating the effectiveness of
treatment methods intended to improve or maintain the microbiological quality of procedural water from dental
units and other dental equipment under laboratory conditions.
It does not establish specific upper limits for microbial contamination or describe test methods to be used in
clinical situations.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 7494-1, Dentistry — Dental units — Part 1: General requirements and test methods
ISO 7494-2, Dentistry — Dental units — Part 2: Water and air supply
ISO 19458, Water quality — Sampling for microbiological analysis
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1, ISO 1942, ISO 7494-1 and
ISO 7494-2 and the following apply. Two of the terms taken from other documents are reproduced below for
convenience and the sake of clarity.
3.1
biofilm
structured community of microorganisms inhabiting a self-developed extracellular biopolymeric matrix
attached to a surface
© ISO 2009 – All rights reserved 1

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ISO/TS 11080:2009(E)
3.2
dental unit
combination of interconnected dental equipment and dental instruments constituting a functional assembly for
use in the provision of dental treatment
[ISO 1942:—, definition 2.86]
3.3
procedural water
water supplied by the dental unit for use in the oral cavity
EXAMPLE Handpiece coolant water, syringe water, scaler coolant water or rinse cup water.
[ISO 7494-2:2003, definition 3.1]
4 Dental unit water treatment methods
Technical approaches for improving or maintaining the microbiological quality of dental unit procedural water,
which are currently available, include, but need not be limited to:
⎯ dental units with automatic or passive water treatment devices and/or antimicrobial materials;
⎯ independent water bottles with intermittent or continuous chemical treatment.
The test method used to evaluate a treatment method shall be specified with consideration for the technical
approach of the method. Depending upon the specific technical approach of a treatment method and its
intended benefits, the test method shall evaluate one or both of the following aspects:
⎯ removal of biofilm from surfaces within the dental unit water delivery system;
⎯ prevention or inhibition of biofilm formation on surfaces within the dental unit water delivery system.
Separate test method characteristics are specified in Clause 5 for each of the above performance metrics.
5 Test methods
5.1 General
Test methods shall replicate the conditions of use and the technical approach specified by the manufacturer of
the dental unit or waterline treatment product.
The test apparatus should preferably consist of dental units. As an alternative, surrogate systems, which
closely replicate the dental unit water system, may be used as the test apparatus. Test apparatus design and
operation characteristics are specified in Clause 6.
Initial validation testing shall be performed under controlled laboratory conditions and not in clinical settings.
Test methods shall include untreated controls.
Since there is inherent variation in biofilm formation, testing should be replicated on separate dental units or
surrogate waterline systems. Test methods shall specify the number of test replicates to be included in the
test group and control group. At least two units shall be included in the test group and at least one unit shall
be included in the control group.
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ISO/TS 11080:2009(E)
5.2 Test methods for evaluating biofilm removal
5.2.1 General
Test methods for evaluating treatment methods that are intended to remove dental waterline biofilms shall
include the following steps.
5.2.2 Biofilm formation and characterization
A biofilm shall be established in the test apparatus in a manner consistent with biofilms occurring in typical
clinical situations. The method for establishing a biofilm in the test apparatus shall be able to be replicated by
independent evaluators.
The preferred method for generating a biofilm in the test apparatus consists of conditioning the test apparatus
by flowing a microbiological challenge suspension through the test apparatus for a period sufficient to
establish a reproducible biofilm.
Test apparatus design and operation characteristics are specified in Clause 6.
Microbiological challenge characteristics are specified in 7.1 and 7.2.2.
Chemical characteristics of the water used in the biofilm formation shall be consistent with the specifications in
Clause 8.
The presence of an established biofilm shall be verified using the methods specified in Clause 9. Colony
counts in the effluent water from the test apparatus should be consistent with those found in typical clinical
4 6
situations: 10 CFU/ml to 10 CFU/ml.
5.2.3 Application of the treatment method
The treatment method for removal of the established biofilm shall be administered in accordance with the
instructions of the manufacturer of the dental unit or waterline treatment product (except for the untreated
control group).
Chemical characteristics of the water used in the appl
...

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