A new technical specification, ISO/TS 17665-3, “Sterilization of health care products – Moist heat – Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization,” has just been issued. You can buy the ISO/TS 17665-3 from Document Center Inc. in paper format or to download as a pdf copy. The new specification is the 3rd part in this series on efficient sterilization of medical devices and is meant to be used with Parts 1 and 2.
In most health care facilities, sterilization of medical devices and health care products is done by the steam sterilization method. It consists of three distinct stages: air removal, sterilizing and drying.
This standard is intended to assure sterilization when multiple products are processed at the same time. This “sterilization load” is made safe by processing product families that have been pre-screened using the ISO/TS 17665-3 standard methodology.
ISO/TS 17665-3 helps the user define the attributes of the device for assigning a product family category for the moist heat sterilization process. These attributes have been chosen based on operation experience, engineering considerations and experimental data. They rely on the types and designs of differing medical devices and sterile barrier and/or packaging systems.
The three documents that make up the series are:
- ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO/TS 17665-2:2009, Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1, and
- ISO/TS 17665-3:2013, Sterilization of health care products – Moist heat – Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
You can purchase ISO standards, both current editions and many obsolete revisions, at Document Center’s web store, www.document-center.com. Or you can reach us by phone (650-591-7600), fax (650-591-7617) or email (firstname.lastname@example.org). We’re Your Standards Experts and we’re here to make sure you have the standards you need to run your business effectively.