DIN EN ISO 18472:2006
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006); English version of DIN EN ISO 18472:2006-10

Standard No.

DIN EN ISO 18472:2006

Release Date

2006

Published By

German Institute for Standardization

Status

Be replaced 2018-11

Replace By

DIN EN ISO 18472:2018

DIN EN ISO 18472 E:2016

Latest

DIN EN ISO 18472:2018-11

Replace

DIN EN 866-6:2000 DIN EN 866-7:2000 DIN EN 866-8:2000 DIN EN ISO 18472:2004 DIN EN 866-3:1997 DIN EN 866-2:1997

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 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 using laboratory 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 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.

DIN EN ISO 18472:2006 Referenced Document

• ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes*， 2017-03-01 Update
• ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes*， 2017-02-28 Update
• ISO 11138-4 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes*， 2017-03-01 Update
• ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
• ISO 11140-4 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration*， 2007-03-01 Update

DIN EN ISO 18472:2006 history

• 2018 DIN EN ISO 18472:2018-11 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018); German version EN ISO 18472:2018
• 2018 DIN EN ISO 18472:2018 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
• 2017 DIN EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
• 2006 DIN EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006); English version of DIN EN ISO 18472:2006-10
• 0000 DIN EN ISO 18472:2004
• 0000 DIN EN 866-8:2000
• 0000 DIN EN 866-2:1997