VOTE ON COMMITTEE DRAFT ISO/CD 10993-10

We agree to the circulation of the draft as a DIS
in accordance with 2.6.1 of part of the ISO/IEC Directives
with comments.

See attached comments:

p21
    Add the following language at the bottom of this page
    as a NOTE of Table 4.

    NOTE: Grading with primary irritation index (6.3.6 and Table 1)
          is also usable.

    [REASON] This grading criteria has been used frequently
          such as in the original version of part 10,
          the Japanese Guidelines, as well as in many papers.
          
p55, 3rd paragraph, line 4
    Delete 1 from "defined in terms 1 of the minimum ---".

p55, 4th paragraph, line 2
    "However" should read "Accordingly".

p55, 4th paragraph, line 4
    Add comma (,) before "allergen ---".

p55, 4th paragraph, line 2 from the bottom
    "The extracts made with solvent" should read 
    "The extracts made with organic solvent."

p55, 5th paragraph 
    Exchange the whole with the following:

    The Japanese Guidelines of Basic Biological Tests
    of Medical Materials and Devices (1995) adopts the
    sample preparation procedure with organic solvent
    followed by evaporation of the solvent to obtain
    the residue, and the risk assessment procedure by
    comparing the % residue yield from the material with
    the minimum % dilution of the residue (mixture) that
    still induced delayed hypersensitivity in animals.