ANSI/ AAMI/ISO 18472:2006 pdf download – Sterilization of health care products — Biological and chemical indicators — Test equipment.
1 Scope 1.1 This International Standard specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 1 1 1 40-1 for chemical indicators, or the requirements given in the ISO 1 1 1 38 series for biological indicators. This International Standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. ISO 1 1 1 38-2, ISO 1 1 1 38-3, ISO 1 1 1 38-4, and ISO 1 1 1 40-1 require the use of resistometers specified in this International Standard, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 1 1 1 38 and ISO 1 1 1 40. NOTE Resistometers for formaldehyde indicators are not included in this International Standard. Test methods using laboratory apparatus for steam-formaldehyde are included in ISO 1 1 1 38-5, ISO 1 1 1 40-3, and ISO 1 1 1 40-4. 1.2 This International Standard does not address the methods used to demonstrate compliance of biological or chemical indicators to ISO 1 1 1 38 and ISO 1 1 1 40, as these are covered in the appropriate parts of these standards. Indicators used with combination processes, such as washer-disinfection, are not covered by this International Standard. NOTE Test equipment and methods necessary for ISO 1 1 1 40-3, ISO 1 1 1 40-4 or ISO 1 1 1 40-5 are specified in those standards. 1.3 This International Standard does not address safety aspects of the test equipment because these are usually covered by specific regional, national or local regulations. 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.
3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 1 1 1 38, ISO 1 1 1 40 and the following apply. 3.1 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process [ISO/TS 1 1 1 39:2006, definition 2.3] 3.2 calibration set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards [VIM 1 993, definition 6.1 1 ] 3.3 chemical indicator non-biological indicator system that reveals change in one or more predefined process variables based on a chemical or physical change resulting from exposure to a process [ISO/TS 1 1 1 39:2006, definition 2.6]