1990 Edition, August 31, 1990
Evaluation of Medical Devices for Biological Hazards Part 11: Method of Test for Haemolysis
Superseded By: BS EN 30993-4
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Description / Abstract:
Intended to assess haemolytic effects in vitro of leachable endogenous or extraneous substances present in or on a medical device as a result of direct contact between device material and rabbit blood. The method involves quantification of haemolysis by spectrophotometric measurement of plasma haemoglobin.