ISO 17664:2004
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
- Standard No.
- ISO 17664:2004
- Release Date
- 2004
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 17664:2017
- Latest
- ISO 17664:2017
- Scope
- 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.
ISO 17664:2004 history
- 2017 ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
- 2004 ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
