International Organization for Standardization (ISO)
Latest
ISO 16954:2015
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.
ISO 16954:2015 Referenced Document
ASTM E1427-00 Standard Guide for Selecting Test Methods to Determine the Effectiveness of Antimicrobial Agents and Other Chemicals for the Prevention, Inactivation and Removal of Biofilm*, 2024-04-20 Update
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance