Acceptability of New Technology Respirator Fit Testing Devices
HPPOS-175 PDR-9111210266
Title: Acceptability of New Technology Respirator Fit
Testing Devices
See the memorandum from R. L. Pedersen to M. M. Shanbaky
(and others) dated April 10, 1989. The memo states that
new technology devices can be used to conduct quantitative
fit testing of respirators provided the device can be shown
to be technically adequate, satisfies regulatory
commitments, and meets the intent of the regulatory
requirements.
The Radiation Protection Branch was queried on the
acceptability of new respirator fit testing devices that
were on the market. When determining that a method is
technically adequate, an inspector should keep in mind that:
1. Fit Factors determined by any quantitative fit test
are not Protection Factors and can not be used as such.
2. Acceptance criteria for Fit Factors should be set
at least ten times the Protection Factor of the mask being
fit (i.e., to show a proper fit on a mask with a protection
factor of 50, a Fit Factor of at least 500 should be
measured).
3. Testing methods should reasonably simulate use
conditions.
4. An adequate base for correlating the parameter
being measured (aerosol concentration, pressure drop, etc.)
to a Fit Factor, should be established.
It has been reported that one device on the market,
QUANTAFIT, requires the subject to be absolutely still with
no facial movement. Apparently momentary breaks in the
face seal, caused by facial movement, fail the test. This
type of leakage is well known even in a good fitting
respirator and it is a major contributor to the overall
leakage (or fit) of the mask. If this information is
correct, it is difficult to see how this method can
adequately measure the respirator fit.
Regulatory references: 10 CFR 20.103, 10 CFR 20.1703
Subject codes: 5.6, 8.10
Applicability: All