BS PD ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.

This document includes considerations on the:

• characterization of nanomaterials;
• sample preparation for testing of nanomaterials;
• release of nano-objects from medical devices;
• toxicokinetics of nano-objects;
• biological evaluation of nanomaterials;
• presentation of results;
• risk assessment of nanomaterials in the context of medical device evaluation;
• biological evaluation report;
• nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.

The following are excluded from this document:

• natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;
• intrinsic nanostructures in a bulk material;
• nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.

NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.

This document is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.


Cross References:
ISO 10993-11:2006
ISO 10993-12:2012
ISO/TR 13014:2012 ED1
ISO 10993-16:2017
ISO 10993-1:2009
ISO 14971:2007 Ed 2 (R10) ISO 10801:2010 Ed 1
ISO 17973:2016
ISO/TR 13097:2013 ED1
ISO 24236:2005 (R10) Ed 1
ISO/TR 27628:2007 (R10) Ed 1
ISO 9276-3:2008 Ed 1
ISO 21501-3:2007 Ed 1
ISO 13322-1:2014 ED2
ISO 13318-3:2004 Ed 1
ISO 20998-2:2013 ED1
ISO/TS 19590:2017
ISO/TS 16550:2014 ED1
ISO 22412:2017
ISO 15471:2016
ISO 22489:2016
ISO 9276-4:2001 Ed 1
ISO 13099-1:2012 ED1
ISO 25178-2:2012
ISO 25178-6:2010 Ed 1
ISO 13322-2:2006 Ed 1
ISO/TR 15499:2012 ED1
ISO 13320:2009 Ed 1
ISO 10808:2010 Ed 1
ISO 22309:2011 Ed 2
ISO 9277:2010 Ed 2
ISO/TS 12025:2012 ED1
ISO 29701:2010 Ed 1
ISO 21501-4:2007 Ed 1
ISO 20998-1:2006 Ed 1
ISO/TR 13121:2011 Ed 1
ISO/TR 16197:2014 ED1
ISO 18115-1:2013 ED2
ISO 25178-71
ISO 9276-6:2008 Ed 1
ISO 13084:2011 Ed 1
ISO/TR 15900
ISO 11360
ISO/TR15901
ISO/TR 14187:2011 Ed 1
ISO 17853:2011 Ed 3
ISO/TS 17200:2013 ED1
ISO 14488:2007 Ed 1
ISO 25178-71:2012 ED1
ISO/IEC 17025:2005 Ed 1
ISO/TR 16196:2016
ISO 13099-2:2012 ED1
ISO 14887:2000
ISO 25178-72:2017
ISO 20998-3:2017
ISO 13318-2:2001 Ed 1
ISO 24173:2009 Ed 1
ISO/TS 80004-1:2015
ISO/TS 80004-6:2013 ED1
ISO 21501-2:2007 Ed 1
ISO 19007
ISO 18757:2003 (R09) Ed 1
ISO/TS 80004-2:2015
ISO 9276-2:2014 ED2
ISO/TS 16195:2013 ED1
ISO 21501-1:2009 Ed 1
ISO 18144:2003 (R09) Ed 1
ISO/TR 19319:2013 ED2
ISO 18115-2:2013 ED2
ISO 18118:2015 ED2
ISO 13099-3:2014 ED1
ISO 16700:2016
ISO 13318-2:2007 Ed 2


All current amendments available at time of purchase are included with the purchase of this document.