AAMI BIOT9 PDF

AAMI BIOT9 – Biological Evaluation of Medical Devices, Supplement 2 (1999)

New supplement to 1997 edition of BIOLOGICAL EVALUATION OF MEDICAL DEVICES, containing two revised standards — 10993-5 on tests for cytotoxicity: in vitro methods and 10993-9 on degradation of materials; a new standard 10993-13 on identification and quantification of degradation products from polymeric devices; as well as AAMI TIR19:1998, which provides guidance on the application of 10993-7 (sterilization residuals) and a 1999 amendment to the TIR. Combined index of all current documents in the three-book biological evaluation collection included. NOTE: See also 1997 edition [order code BIOT7] and 1998 supplement [order code BIOT8]. Books can be purchased alone or as part of a three-book set [order code BIOT9-S].