Ensuring that health products are sterile can be crucial to the safety of patients. The new standard ISO 20857:2010, Sterilization of health care products – Dry heat – Requirements for the development, validation and routine control of a sterilization process for medical devices, will help manufacturers, laboratories, regulators and health care practitioners worldwide to promote good sterilization practices. The standard applies both to reuseable health care products that are reprocessed by health care providers and to single-use products that are sterilized as part of the manufacturing process and are shipped in a sterile state.
ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. It also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.
Compliance with the requirements of this International Standard will ensure that these activities are both reliable and reproducible.
In addition to the health care aspect, ISO 20857 will help facilitate the international trade of sterile medical devices.
ISO 20857:2010 promotes good practices in order to prevent infections and promote patient health. It provides manufacturers and health care providers with clearly defined requirements for sterilization processes and related equipment will help decrease the probability that patients using health care products will be exposed to potentially pathogenic microorganisms. Even in countries that may not have well-established regulatory schemes, the standard can promote safe sterilization practices by health care providers and help assure that products sold as sterile are, in fact, sterile.
ISO 20857:2010, Sterilization of health care products – Dry heat – Requirements for the development, validation and routine control of a sterilization process for medical devices was prepared by ISO technical committee ISO/TC 198, Sterilization of health care products and is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 158 Swiss francs, through the ISO Store or by contacting the Marketing, Communication & Information department (see right-hand column).