Standard: AAMI - 11138-2
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
This standard is available 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
HOW TO SUBSCRIBE
This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135.
NOTE 2 National or regional regulations could provide requirements for work place safety.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Most Recent Revision:||NO|
|Document #||Change Type||Update Date||Revision||Status|
|AAMI 11138-2||Change Type: COMPLETE REVISION||Update Date: 2017-01-01||Revision: 17||Status: ACTV|
|11138-2||Change Type:||Update Date: 2006-01-01||Status: INAC|