DIN EN ISO 10993-13:2010-11

Degradation products covered by this standard are formed primarily by chemical bond scission due to hydrolytic and/or oxidative processes in an aqueous environment. It is recognized that additional biological factors, such as enzymes, other proteins and cellular activity, can alter the rate and nature of degradation. The identified and quantified degradation products form the basis for biological evaluation in accordance with ISO 10993-1, for risk assessment in accordance with ISO 10993-17 and, if appropriate, for toxicokinetic studies in accordance with ISO 10993-16.