標準號：BS EN ISO 17664-2004
中文標準名稱：醫療器械的消毒.生產商提供的可再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：C30
發布日期：2004/3/12 12:00:00
實施日期：2004/3/12 12:00:00
中國標準分類號：C30
國際標準分類號：11.080.01
適用范圍：ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. ISO 17664:2004 specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification.Requirements are specified for processing that consists of all or some of the following activities: a) preparation at the point of use;b) preparation, cleaning, disinfection;c) drying;d) inspection, maintenance and testing;e) packaging;f) sterilization;g) storage.When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing. It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards. In this case, a reference in the instructions is all that is required. For those medical devices where instructions for use are not required to accompany the medical device, other means of communicating the information can be used, e.g. user manuals, symbols or wall charts supplied separately.The principles of ISO 17664:2004 may be applied when considering the information to be supplied with medical devices which only require disinfection prior to re-use. ISO 17664:2004 is not applicable to textile devices used in patient-draping systems or surgical clothing.