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|  MIL-M-85831 (AS)
4.8.3.4 Prophetic human patch testing. The mask shall be tested as
specified in the Food Drug and Cosmetic Law Journal, 10:722, "Draize Human
Sensitization Test." For the testing, there shall be 200 free living
volunteers. Each volunteer shall have the formulation to be tested applied to
the same site of skin nine times. A negative control shall be administered
The substances shall be covered by an occlusive patch and be
concurrently.
kept in contact with the skin for 48-72 hours, each application. Irritation
shall be scored upon removal of each patch. A rest or incubation period
period of 14 days shall then be allowed and a final application of each of the
substances to be tested to a fresh site of the skin.shall be. performed. T h e .
results of the test shall be scored on a O to 4 basis. with: -
=
Negative
0
1
=
Erythema
2
=
Erythema and Induration
3
=
Erythema, Induration and vesicles
4
=
Erythema, induration and bullae
Volunteers partlcipating In the test shall receive a general medical
examination to include a complete medical history by the principal
investigator or his designated representatives to assure that the subjects are
free of any medical condition which might preclude them from participating in
this test or or any medical condition which might be aggravated as a result of
their participation in this test. Conditions which shall exclude Individuals
from participating include the presence of dermatitis or a history of allergy
to components of the materials being tested. Nurses and physicians shall
always be on-call 24 hours a day during the course of the test as well as the
principal investigator or his associates and be at the site within one hour
should the need arise. Such an emergency, as a result of patch testing, is
not anticipated. The tests shall be "read" by the principal investigator and
his staff and reported in accordance with the scoring procedure outlined
above. In these tests, each volunteer acts as his own control in that the
materials used to cover the substances applied are known to have extremely low
sensitizing potential, thus any responses, consistant with sensitization,
elicited after application of a substance are considered evidence of
sensitization to that substance. Such evidence in one or more volunteers
shall , for any particular substance tested, identify that the substance as
having skin sensitizing potential. The mask shall pass the requirements
specified in 3.8.17.4.
4.8.4 Reliability. Five masks shall be tested using Test Plan IVC of
Each mask shall be subjected to 315 hours of testing. The test
MIL-STD-781.
cycle shall be 14 hours in duration and shall consist of a 7 hour hot mission
and a 7 hour cold mission. Cold mission temperature levels shall start at
+131 F, rise to +158F for 1 hour followed by 1 hour at +131F with the
remaining 5 hours at -14F. Hot mission temperature levels shall start at
-14F lowered to -40 F for 1 hour, followed by 1 hour at -14 F, with the
remaining 5 hours at +131 F. The masks shall be subject to the performance
tests of 4.8.2.1, 4.8.2.2, 4.8.2.3, 4.8.2.4, 4.8.2.5, 4.8.2.6, 4.8.2.7, and
meet the requirements of 3.7.
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