ISO 16954:2015
Dentistry — Test methods for dental unit waterline biofilm treatment
ISO 16954:2015 provides type test methods for evaluating the effectiveness of treatment methods intended to prevent or inhibit the formation of biofilm or to remove biofilm present in dental unit procedural water delivery systems under laboratory conditions.
It does not apply to devices intended to deliver sterile procedural water or sterile solution. It also does not apply to lines, tubing, or hoses that deliver compressed air within the dental unit.
It does not establish specific upper limits for bacterial contamination or describe test methods to be used in clinical situations. It also does not establish test methods for evaluating any deleterious side effects potentially caused by treatment methods.
The test methods provided in ISO 16954:2015 can be used to test other dental equipment that delivers non-sterile water to the oral cavity.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Treatment methods
5 Test water and bacterial challenge suspensions
5.1 Test water
5.1.1 Reagents
5.1.2 Preparation of hardness stock solution 1
5.1.3 Preparation of hardness stock solution 2
5.1.4 Preparation of test water prior to inoculation
5.2 Bacterial challenge
5.3 Inoculated test water
6 Test apparatus
6.1 Test apparatus design
6.1.1 General
6.1.2 Considerations specific to antimicrobial materials and materials which prevent microbial adhesion
6.2 Test apparatus operation
6.2.1 Flow rates
6.2.2 Flow patterns (on-off cycles)
6.2.3 Test environment temperature and preconditioning period
7 Test procedures
7.1 Testing sequence
7.2 Biofilm prevention or inhibition
7.2.1 General
7.2.2 Pretreatment of the test apparatuses
7.2.3 Concurrent exposure to inoculated test water and the treatment method for biofilm prevention or inhibition
7.2.4 Microbiological sampling and testing
7.2.5 Test duration
7.2.6 Analysis of results
7.3 Biofilm removal
7.3.1 General
7.3.2 Initial microbiological sampling and testing
7.3.3 Application of the biofilm removal treatment method
7.3.4 Final microbiological sampling and testing
7.3.5 Analysis of results
8 Microbiological sampling and testing
8.1 Enumeration of bacteria levels in procedural water
8.1.1 Sampling
8.1.2 Total viable count test procedure
8.1.3 Alternative total viable count test procedure
8.2 Biofilm on waterline surfaces
8.2.1 Sampling
8.2.2 Biofilm assessment test procedure
9 Test Report
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Treatment methods
5 Test water and bacterial challenge suspensions
5.1 Test water
5.1.1 Reagents
5.1.2 Preparation of hardness stock solution 1
5.1.3 Preparation of hardness stock solution 2
5.1.4 Preparation of test water prior to inoculation
5.2 Bacterial challenge
5.3 Inoculated test water
6 Test apparatus
6.1 Test apparatus design
6.1.1 General
6.1.2 Considerations specific to antimicrobial materials and materials which prevent microbial adhesion
6.2 Test apparatus operation
6.2.1 Flow rates
6.2.2 Flow patterns (on-off cycles)
6.2.3 Test environment temperature and preconditioning period
7 Test procedures
7.1 Testing sequence
7.2 Biofilm prevention or inhibition
7.2.1 General
7.2.2 Pretreatment of the test apparatuses
7.2.3 Concurrent exposure to inoculated test water and the treatment method for biofilm prevention or inhibition
7.2.4 Microbiological sampling and testing
7.2.5 Test duration
7.2.6 Analysis of results
7.3 Biofilm removal
7.3.1 General
7.3.2 Initial microbiological sampling and testing
7.3.3 Application of the biofilm removal treatment method
7.3.4 Final microbiological sampling and testing
7.3.5 Analysis of results
8 Microbiological sampling and testing
8.1 Enumeration of bacteria levels in procedural water
8.1.1 Sampling
8.1.2 Total viable count test procedure
8.1.3 Alternative total viable count test procedure
8.2 Biofilm on waterline surfaces
8.2.1 Sampling
8.2.2 Biofilm assessment test procedure
9 Test Report
Bibliography