[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR84.64]

[Page 518]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 84_APPROVAL OF RESPIRATORY PROTECTIVE DEVICES--Table of Contents
 
       Subpart G_General Construction and Performance Requirements
 
Sec. 84.64  Pretesting by applicant; approval of test methods.

    (a) Prior to making or filing any application for approval or 
modification of approval, the applicant shall conduct, or cause to be 
conducted, examinations, inspections, and tests of respirator 
performance which are equal to or exceed the severity of those 
prescribed in this part.
    (b) With the application, the applicant shall provide a statement to 
the Institute showing the types and results of the examinations, 
inspections, and tests required under paragraph (a) of this section and 
state that the respirator meets the minimum requirements of subparts H 
through L of this part, as applicable. Complete examination, inspection, 
and test data shall be retained on file by the applicant and be 
submitted, upon request, to the Institute.
    (c) The Institute may, upon written request by the applicant, 
provide drawings and descriptions of its test equipment and otherwise 
assist the applicant in establishing a test laboratory or securing the 
services of a testing agency.
    (d) No approval will be issued until the Institute has validated the 
applicant's test results.