ISO 11140-1, “Sterilization of health care products — Chemical indicators — Part 1: General requirements,” is one of our popular standards on the subject. So it’s big news when a new edition is released. The 3rd Edition is available now at Document Center Inc. You can get your copy in paper format, for pdf download, or as part of your Standards Online annual multi-user subscription service. Let’s talk about the standard.
This is a technical update, so the 3rd edition makes the 2nd edition obsolete. It’s used for sterilization processes that use steam, dry heat, ethylene oxide, radiation, low temperature steam and formaldehyde or vaporized hydrogen peroxide. As you can see, these processes can involve hazardous materials, operations, and/or equipment.
It’s expected that the users of the standard will be manufacturers of chemical indicators or indicator systems, which can be used to differentiate between processed and unprocessed items, monitor the completion of the sterilization process and so on. They’re divided into 6 types, all covered by this document.
In addition to defining the various types of indicators, ISO 11140-1 also gives you the general requirements, performance requirements, and basic test methods you’ll be using. Then the remaining 6 Sections review additional requirements that are necessary for specific types.
There are also 5 Annexes. The first is a requirement of the standard, Method for demonstrating shelf-life of the product. The balance provide you with information on testing indicators, the relationship of the indicator and the indicator system components, and so on.
FYI: In the ISO 11140 series, there used to be five separate parts. However, Part 2 on Test Equipment and Methods has been withdrawn in favor of the ISO 18472, “Sterilization of health care products – Biological and chemical indicators – Test equipment.”
You’ll need to get your copy. So head to Document Center’s webstore at www.document-center.com. Here’s you’ll order any standards you need. Or feel free to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can assist you with those pesky questions you may have regarding how to correctly use and maintain your standards collection. Make us your Standards Experts!
