标准号：ISO 17664-2004
实施状态：作废
中文名称：医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息
英文名称：Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
发布日期：2004-03
被替代标准：ISO 17664-2017
代替标准：ISO/FDIS 17664-2003
采用标准：DIN EN ISO 17664-2004,IDT;ABNT NBR ISO 17664-2015,IDT;BS EN ISO 17664-2004,IDT;EN ISO 17664-2004,IDT;NF S98-116-2004,IDT;CAN/CSA-Z17664-06-2006,IDT;SN EN ISO 17664-2004,IDT;OENORM EN ISO 17664-2004,IDT;PN-EN ISO 17664-2005,IDT;SS-EN ISO 17664-2004,IDT;UNE-EN ISO 17664-2004,IDT;SANS 17664-2007,IDT;GOST R ISO 16061-2011,IDT;GOST R ISO 17664-2012,IDT;DS/EN ISO 17664-2004,IDT;UNI EN ISO 17664-2005-2005,IDT;STN EN ISO 17664-2004,IDT;SANS 17664-2007,IDT;SANS 17664-2007-2007,IDT;CSN EN ISO 17664-2004,IDT;DS/EN ISO 17664-2004,IDT;NEN-EN-ISO 17664-2004 en-2004,IDT;SANS 17664-2007-2007,IDT
起草单位：ISO/TC 198
标准简介：This standard specifies the information to be provided by the medical device manufacturer on the
processing of medical devices claimed to be re-sterilizable and medical devices intended to be
sterilized by the processor.
This standard 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:
¾ preparation at the point of use;
¾ preparation, cleaning, disinfection;
¾ drying;
¾ inspection, maintenance and testing;
¾ packaging;
¾ sterilization;
¾ 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.
This standard excludes textile devices used in patient draping systems or surgical clothing.
文件格式：PDF
文件大小：200.99KB
文件页数：26
（以上信息更新时间为：2019-11-22）
ISO 17664-2004 医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息.pdf
(200.99 KB)
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