BS EN ISO 16954:2015 pdf free.Dentistry—Test methods for dental unit waterline biofilm treatment.
BS EN ISO 16954 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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 3696:1987, Water for analytical laboratory use — Specification and test methods
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 10523, Water quality — Determination of pH
ISO 19458, Water quality — Sampling for microbiological analysis
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
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.
3.1 blot ilm structured community of microorganisms inhabiting a self-developed extracellular biopolymeric matrix attached to a surface.
3.2 dental unit combination of interconnected dental equipment and dental instruments constituting a functional assembly for use in the provision of dental treatment [SOURCE: ISO 1942:2009, 2.86]
3.3 dental unit procedural water delivery system system of components of a dental unit which convey water from a supply source to one or more outlets used for dental treatment
3.4 procedural water water supplied by the dental unit for use in the oral cavity EXAMPLE Handpiece procedural water, multifunctional syringe water, scaler procedural water, or rinse cup water. [SOURCE: ISO 7494-2:2003, 3.1]
3.5 surrogate dental unit water system test apparatus which accurately recreates the procedural waterdeliverysystem ofa dental unit, including design, construction, configuration, and operation of all water-bearing elements of the procedural water delivery system, but not necessarily including other dental unit components which do not directly come in contact with or control the flow of procedural water.
3.6 test water water having specified chemical and physical characteristics used for testing prior to the addition of the specified bacterial challenge suspension
3.7 bacterial challenge suspension consortium of specified bacteria suspended in a nutrient growth medium or buffered solution used to inoculate test water.BS EN ISO 16954 pdf free download.