95.99 Withdrawal of Standard Jul 27, 2010
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
11.100.20 Biological evaluation of medical devices
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.
This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.
Guidance is given in annex A for the preparation of materials specifically in relation to the above tests.
Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B.
Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.
WITHDRAWN
ISO 10993-10:1995
WITHDRAWN
ISO 10993-10:2002
95.99
Withdrawal of Standard
Jul 27, 2010
WITHDRAWN
ISO 10993-10:2002/Amd 1:2006
WITHDRAWN
ISO 10993-10:2010