BS EN ISO 10993-4:2009 provides general requirements for evaluating the interactions of medical devices with blood.

BS EN ISO 10993-4:2009 describes

a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,

b) the fundamental principles governing the evaluation of the interaction of devices with blood,

c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.

Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood. Further, this part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The selection and design of test methods should take into consideration device design, materials, clinical utility, usage environment and risk benefit. This level of specificity can only be covered in vertical standards.



Cross References:
ISO 10993-1:1997
ISO 10993-2:1992
ISO 5840:1996
ISO 5841-1
ISO 5841-3
ISO 7198
ISO 7199
ISO 10993-12
ISO 3826
AANSI/AAMI CVP3-1981
ANSI/AAMI VP20-1986
ASTM F 756-00
GB/T 16175-1996
BS 5736-11:1990
ASTM F 1984-99
ASTM F 2065-00
DIN 58361-4:1980
NF 90-300:1981
93/42/EEC
90/385/EEC
86/609/EEC


Incorporates the following:
AMD 14295 published 29 January 2003
AMD 14295 is a Corrigendum. AMD 16584, September 2006 (not available separately)