ISO 16954:2015 pdf download

ISO 16954:2015 pdf download.Dentistry一Test methods for dental unit waterline biofilm treatment
1 Scope
This International Standard 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. This International Standard 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. This International Standard 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 this International Standard can be used to test other dental equipment that delivers non-sterile water to the oral cavity.
6.1 Test apparatus design
6.1.1 General
If the test apparatuses consist of dental units, the dental units shall represent the most challenging model or configuration (when more than one model or configuration is available from the manufacturer). Length of waterlines, number of branch waterlines and likelihood of stagnation are among the factors that shall be considered in determining the most challenging model or configuration. If the test apparatuses consist of surrogate dental unit water systems, the surrogate dental unit water systems must be able to simulate the basic clinical performance parameters of a functioning dental unit, including as described in 6.2. The surrogate dental unit water systems must represent the most challenging model or configuration of the dental unit which the surrogate dental unit water systems are intended to represent (when more than one model or configuration is available from the manufacturer. Surrogate dental unit water systems shall accurately recreate the procedural water delivery system, including design, construction, configuration and operation of the water-bearing elements of the procedural water delivery system. Other components which do not directly come in contact with or control the flow of procedural water need not be included, such as structural and decorative components. The components of surrogate dental unit water systems shall be subject to the same environmental conditions (i.e. light exposure and temperature) as components in the dental units which they represent. Any air gapsystem or other backflow prevention device required to comply with the backflow prevention requirements of ISO 7494 -2 for isolating the procedural water from the incoming water shall be included in the test apparatuses.