ISO 17664:2017

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

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Referenced standards

EN 16442:2015ISO 10993-7:2008ISO 11135:2014ISO 11607-1:2006ISO 13485:2016ISO 14971:2007ISO 15223-1:2016ISO 15883-1:2006ISO 15883-2:2006ISO 15883-3:2006ISO 15883-4:2008ISO 15883-6:2011ISO 15883-7:2016ISO 17665-1:2006ISO 20857:2010ISO 25424:2009ISO 7000:2014ISO 9000:2015ISO/TS 11139:2006ISO/TS 16775:2014
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Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

ISO 17664:2017 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 and/or sterilization to ensure that the device is safe and effective for its intended use.

This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

Edition2017
Published Date2017
Published ByInternational Standardization Organisation
Page Count24