Standard: AAMI 18472

STERILIZATION OF HEALTH CARE PRODUCTS—BIOLOGICAL AND CHEMICAL INDICATORS—TEST EQUIPMENT

This standard is available for individual purchase.

or unlock this standard with a subscription to IHS Standards Expert

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
For additional product information, visit the IHS Standards Expert page.

HOW TO SUBSCRIBE
For more information or a custom quote, visit the IHS Contact Us page for regional contact information.
Scope:

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
Publish Date: 2006-01-01
Page Count: 45
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Standards That Reference This Standard

Showing 1 of 1.


Advertisement
Advertisement
Advertisement
Advertisement