標準號：ISO 18472-2006
中文標準名稱：保健產品的消毒.生物和化學指示劑.試驗器械
英文標準名稱：Sterilization of health care products - Biological and chemical indicators - Test equipment
標準類型：C47
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.20
引用標準：ISO 11138-2;ISO 11138-3;ISO 11138-4;ISO 11140-1;ISO 11140-4
適用范圍：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 11140-1 for chemical indicators, or the requirements given in the ISO 11138 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 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 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 11138 and ISO 11140.NOTE Resistometers for formaldehyde indicators are not included in this International Standard. Test methods usinglaboratory apparatus for steam-formaldehyde are included in ISO 11138-5, ISO 11140-3 and ISO 11140-4.1.2 This International Standard does not address the methods used to demonstrate compliance of biological or chemical indicators to ISO 11138 and ISO 11140, 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 11140-3, ISO 11140-4 or ISO 11140-5 are specified in thosestandards.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.