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NEN-EN-ISO 17664

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

inactive
Organization: NEN
Publication Date: 1 April 2004
Status: inactive
ICS Code (Sterilization and disinfection in general): 11.080.01
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:-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 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.

Document History

January 1, 2018
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
NEN-EN-ISO 17664 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection...
NEN-EN-ISO 17664
April 1, 2004
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
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...
May 1, 2001
Sterilization of medical devices - Information to be provided by the manufacturer for the reprocessing of resterilizable devices
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...

References

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