a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;
tuairisc ar na hamhábhair atá ionchorpraithe i bpríomheilimintí feidhmiúla agus iad siúd a bhfuil teagmháil dhíreach acu le corp an duine nó teagmháil indíreach leis an gcorp, e.g., le linn imshruthú sreabhán coirp lasmuigh den chorp;