Standard: AAMI 18472
STERILIZATION OF HEALTH CARE PRODUCTS—BIOLOGICAL AND CHEMICAL INDICATORS—TEST EQUIPMENT
This standard is available for individual purchase.
IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).FEATURES & BENEFITS
- Maximize product development and R&D with direct access to over 1.6 million standards
- Discover new markets: Identify unmet needs and discover next-generation technologies
- Improve quality by leveraging consistent standards to meet customer and market requirements
- Minimize risk: Mitigate liability and better understand compliance regulations
- Boost efficiency: Speed up research, capture and reuse expertise
HOW TO SUBSCRIBE
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.
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.
This International Standard does not address safety aspects of the test equipment because these are usually covered by specific regional, national or local regulations.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 18472|
|Most Recent Revision:||YES|
This Standard References
Showing 10 of 14.
Standards That Reference This Standard
Showing 1 of 1.