BS PD ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that arecomposed of or contain nanomaterials. In addition, this guidance can also be used for the evaluationof 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 aremanufactured 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 orprocessed 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 duringthe engineering, manufacturing or processing of a medical device.
NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw linesand machining/tool marks.This document is intended to provide a general framework and highlights important aspects whichneed to be considered when assessing the safety of medical devices composed of, containing and/orgenerating nano-objects. Additionally, the document identifies several common pitfalls and obstacleswhich have been identified when testing nanomaterials compared to bulk materials or small moleculechemical species. As a technical report (TR), this document represents the current technical knowledgerelated to nanomaterials. No detailed testing protocols are outlined or provided. This document canserve as a basis for future documents containing detailed protocols with a focus on nanomaterialtesting.
Cross References:ISO 10993-11:2006ISO 10993-12:2012ISO/TR 13014:2012 ED1ISO 10993-16:2017ISO 10993-1:2009ISO 14971:2007 Ed 2 (R10) ISO 10801:2010 Ed 1ISO 17973:2016ISO/TR 13097:2013 ED1ISO 24236:2005 (R10) Ed 1 ISO/TR 27628:2007 (R10) Ed 1ISO 9276-3:2008 Ed 1ISO 21501-3:2007 Ed 1ISO 13322-1:2014 ED2ISO 13318-3:2004 Ed 1ISO 20998-2:2013 ED1 ISO/TS 19590:2017ISO/TS 16550:2014 ED1ISO 22412:2017ISO 15471:2016ISO 22489:2016ISO 9276-4:2001 Ed 1ISO 13099-1:2012 ED1 ISO 25178-2:2012ISO 25178-6:2010 Ed 1ISO 13322-2:2006 Ed 1ISO/TR 15499:2012 ED1ISO 13320:2009 Ed 1ISO 10808:2010 Ed 1ISO 22309:2011 Ed 2ISO 9277:2010 Ed 2ISO/TS 12025:2012 ED1ISO 29701:2010 Ed 1ISO 21501-4:2007 Ed 1ISO 20998-1:2006 Ed 1ISO/TR 13121:2011 Ed 1ISO/TR 16197:2014 ED1ISO 18115-1:2013 ED2ISO 25178-71ISO 9276-6:2008 Ed 1ISO 13084:2011 Ed 1ISO/TR 15900ISO 11360ISO/TR15901ISO/TR 14187:2011 Ed 1ISO 17853:2011 Ed 3 ISO/TS 17200:2013 ED1ISO 14488:2007 Ed 1ISO 25178-71:2012 ED1ISO/IEC 17025:2005 Ed 1ISO/TR 16196:2016ISO 13099-2:2012 ED1ISO 14887:2000ISO 25178-72:2017ISO 20998-3:2017ISO 13318-2:2001 Ed 1 ISO 24173:2009 Ed 1ISO/TS 80004-1:2015ISO/TS 80004-6:2013 ED1ISO 21501-2:2007 Ed 1ISO 19007ISO 18757:2003 (R09) Ed 1ISO/TS 80004-2:2015ISO 9276-2:2014 ED2ISO/TS 16195:2013 ED1ISO 21501-1:2009 Ed 1ISO 18144:2003 (R09) Ed 1ISO/TR 19319:2013 ED2ISO 18115-2:2013 ED2ISO 18118:2015 ED2ISO 13099-3:2014 ED1ISO 16700:2016ISO 13318-2:2007 Ed 2
