Requirements for the development, validation and routine control of sterilisation processes for medical devices and other healthcare products are described in ISO 11135 (for ethylene oxide), ISO 11137 (for radiation) and ISO 17665 (for moist heat). In summary, an effective sterilisation process includes comprehensive documentation of a manufacturer’s validation protocols and reports, along with related laboratory compliance data. For sterilisation processes involving reprocessing, a comprehensive risk management assessment must also be completed. This documentation becomes part of the product design dossier or technical file, which is generally required for medical device approval or placement on the market.
Medical device manufacturers often face a number of issues in implementing and maintaining appropriate sterilisation process and controls. The science of sterilisation is complex and requires expertise in a number of technical areas, such as microbiology, chemistry and engineering. Standards applicable to the control and validation of industrial sterilisation processes are extensive, and it can be difficult to determine in advance how a given standard’s requirements will be interpreted by regulatory authorities during the conformity assessment process. In addition, regulatory requirements applicable to sterilisation processes and validation can change in light of new scientific information. These and other issues can slow the regulatory review and approval process for medical device manufacturers.