The ISO 11138 series, Sterilization of health care products – Biological indicators, has just been updated. All 5 parts in the series have been released as a new 2017 Edition. These are important sterilization standards for the health care industry. You’ll want to get your copies ASAP from Document Center Inc. so here is the order page for all 5 ISO 11138 Parts.
Biological indicators are inoculated carriers and suspension used for validating and monitoring sterilization processes. The ISO 11138 series provides manufacturers and others with the requirements for production, labeling, test methods and performance requirements of these substances. They are a vital part of insuring that sterile medical devices and products are used in health care settings.
The ISO 11138 series underwent a major revision back in 2006. The original Parts 1, 2 and 3 were complimented by the release of Parts 4 and 5 at that time. The 2017 updates represent the first change since then. All 5 2017 Revisions are a technical update and so replace and withdraw the previous 2006 Editions. Here’s more information about each document in the set.
ISO 11138-1, 3rd Edition, Sterilization of health care products – Biological indicators – Part 1: General requirements
This is the overview document, with the basic information common to all of the parts of the series. You’ll get a wide range of information here, including quality considerations, the various test methods used, and so on. Much of this 48 page standard is devoted to the Annexes. A covers how to determine viable count, B is on growth inhibition, C and D contain D value determination methods, E reviews the survival-kill reponse, and F shows you the relationship between various biological indicator components.
ISO 11138-2, 3rd Edition, Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes
Part 2 is the Ethylene oxide sterilization standard. It’s used to calculate the performance of sterilizers using this method. The 14-page standard provides complimentary information to be used in addition to the basics found in Part 1.
ISO 11138-3, 3rd Edition, Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes
Part 3 has specific information on moist heat sterilizers. Specific calculations are provided in this 16 page standard.
ISO 11138-4, 2nd Edition, Sterilization of health care products – Biological indicators – Part 4: Biological indicators for dry heat sterilization processes
The 16 page Part 4 gives you the additional requirements for biological indicators used in the dry heat sterilization process.
ISO 11138-5, 2nd Edition, Sterilization of health care products – Biological indicators – Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
The last Part 5 discusses specifics for low-temperature steam and formaldehyde sterilization process indicators. It’s 14 pages in length.
ISO Technical Committee 198 is in charge of the ISO 11138 series of standards. They have provided no additional information on where the changes have been made in the new updates. The series has been widely adopted for use in a number of jurisdictions. We should expect the changes to the core ISO set to ripple through the U.S. and European standards bodies shortly. We’ll keep you informed as the ANSI/AAMI and EN editions become available, probably later this year.
How can you get your copies of the ISO standards now? Head to Document Center’s webstore at www.document-center.com. You’ll find all ISO standards available for purchase in a secure environment. If you’d like assistance to determine if you need the ISO editions now or should wait for regional adoptions, just get in touch. We can be reached via phone (650-591-7600) and email (info@document-center.com). Document Center Inc. has been working with compliance documents since 1982. Make us your Standards Experts!
