標準號：ISO 17664-2004
中文標準名稱：醫療器械的消毒.生產商提供的可重復消毒醫療器械的處理信息
英文標準名稱：Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
標準類型：C47
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.01
適用范圍：This standard specifies the information to be provided by the medical device manufacturer on theprocessing of medical devices claimed to be re-sterilizable and medical devices intended to besterilized by the processor.This standard specifies requirements for the information to be provided by the medical devicemanufacturer, so that the medical device can be processed safely and will continue to meet itsperformance specification.Requirements are specified for processing that consists of all or some of the following activities:? preparation at the point of use;? preparation, cleaning, disinfection;? drying;? inspection, maintenance and testing;? packaging;? sterilization;? storage.When providing instructions for these activities, medical device manufacturers are expected to beaware of the training and knowledge of procedures, and of the processing equipment available to thepersons likely to be responsible for processing. It is likely that some processing procedures will begeneric and well known and will use equipment and consumables conforming to recognizedstandards. In this case, a reference in the instructions is all that is required. For those medical deviceswhere instructions for use are not required to accompany the medical device, other means ofcommunicating the information can be used, e.g. user manuals, symbols or wall charts suppliedseparately.This standard excludes textile devices used in patient draping systems or surgical clothing.