Changes clauses 4(d), 6.4.4.3.5, 6.4.5.3(e), 7.5.4.3.1, and Annex B.
ANSI/AAMI BE78-2002/A1-2006 history
2006ANSI/AAMI BE78-2002/A1-2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1