Standards Development
This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers an d sterilization processes employing vaporized hydrogen peroxide as the sterilizing agent.
NOTE 1 Requirements for validation and control of vaporized hydrogen peroxide sterilization processes are provided by ISO 22441 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for workplace safety.
Hydrogen peroxide in vapour phase is currently used for terminal sterilization of medical items in health care facilities on a global basis and is also used as a sterilant by medical device and pharmaceutic al manufacturers . Commercially available biological indicators are currently used to valid ate and monitor these processes, however, there are no standard s that specify the testing methods and performance requirements of these biological indicators. ISO 11138-1 specifies production, labelling , test methods and performance requirements for the manufacture of biological in dicators including in oculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. This part o f ISO 11138 will give specific requirements for those biological in dicators intended for use in hydrogen peroxide vapour sterilization processes. EN ISO 11138-6 was developed under VA before. Note: in case the WI is based on documents from other organizations than ISO/IEC , please specify it here
You are now following this standard. Weekly digest emails will be sent to update you on the following activities:
You can manage your follow preferences from your Account. Please check your mailbox junk folder if you don't receive the weekly email.
You have successfully unsubscribed from weekly updates for this standard.
Comment on proposal
Required form fields are indicated by an asterisk (*) character.