This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles

for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Designation: F3620 − 22

Standard Practice for

Respiratory Protection—Respirator Use—Physical
Qualifications for Personnel1
This standard is issued under the fixed designation F3620; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.

1. Scope
1.1 This practice provides information that is useful for the
medical evaluation of respirator users.
1.2 This practice does not deal with medical surveillance or
biological exposure monitoring. It is understood that since
local circumstances vary, no set of guidelines can cover all
situations, and specific programs and procedures should be
modified for each individual workplace. Medical evaluation is
only one element of a complete respiratory protection program.
A complete respiratory protection program is defined in Prac-
tice F3387.
1.3 Units—The values stated in SI units are to be regarded
as standard. No other units of measurement are included in this
standard.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:2
F3387 Practice for Respiratory Protection
2.2 Federal Standards:3
29 CFR 1910.134 Respiratory Protection
29 CFR 1910.155 Fire Protection
1
This practice is under the jurisdiction of ASTM Committee F23 on Personal
Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.65 on Respiratory.
Current edition approved Dec. 1, 2022. Published December 2022. DOI:
10.1520/F3620-22.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from Occupational Safety and Health Administration (OSHA), 200
Constitution Ave., NW, Washington, DC 20210, http://www.osha.gov.
3. Terminology
3.1 Definitions:
3.1.1 body mass index, BMI, n—measurement used to assess
weight relative to height.
3.1.1.1 Discussion—BMI is calculated by dividing body
weight in kilograms by height in metres squared (kg/m2).
3.1.2 canister (air purifying), n—container with (1) gas and
vapor-removing sorbent or catalyst, or (2) gas and vapor-
removing sorbent or catalyst that removes gases and vapors
and filter that removes particles from inspired air (or air drawn
through the unit).
3.1.2.1 Discussion—Typically attached to a full face piece,
either mounted directly to the chin or connected to a breathing
tube so the canister may be worn in the front or back of the
person. Respirators with air-purifying canisters are approved
by National Institute for Occupational Safety and Health
(NIOSH) as gas masks and contain approval number TC-14G-
XXXX.
3.1.3 cartridge, n—small container filled with sorbents or
catalysts that remove gases and vapors from the inspired air.
3.1.3.1 Discussion—The cartridge may also have particulate
filters that are an integral part or ones that are replaceable.
3.1.4 emergency situation, n—any occurrence such as, but
not limited to, equipment failure, rupture of containers, or
failure of control equipment that may or does result in an
uncontrolled significant release of an airborne contaminant.
3.1.5 employee exposure, n—exposure to a concentration of
an airborne contaminant that would occur if the employee were
not using respiratory protection.
3.1.6 end-of-service-life indicator, ESLI, n—system or de-
vice that warns the wearer of the approach of the end of
adequate respiratory protection.
3.1.7 escape-only respirator, n—respirator intended only for
use during emergency egress from a hazardous atmosphere.
3.1.8 exercise stress test, EST, n—standard graded exercise
test used to assess an individual’s ability to tolerate increasing
intensities of exercise while electrocardiographic (EKG),
hemodynamic, and symptomatic responses are monitored for
manifestations of ischemia, electrical instability, or other
exertion-related abnormalities.

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States

1
 F3620 − 22
3.1.9 filter, n—material used in air-purifying respirators to
remove solid or liquid aerosols from inspired air.
3.1.9.1 Discussion—Some filters are encapsulated in a con-
tainer and some are not.
3.1.10 filtering face piece—negative pressure respirator in
which the filter is an integral part of the face piece or comprises
the entire face piece.
3.1.11 fit factor, n—numeric expression of how well a
tight-fitting respirator fits a wearer during a quantitative fit test,
and it is the ratio of the measured challenge agent concentra-
tion outside the face piece (Cout) to its concentration inside the
respirator (Cin) (fit factor = Cout / Cin).
3.1.11.1 Discussion—A fit factor resulting from a qualitative
fit test has been validated to 100.
3.1.12 fit test, n—use of a qualitative or quantitative proto-
col to evaluate sealing surface leakage of a specific tight-fitting
respirator while worn by an individual.
3.1.13 helmet, n—hood that offers head protection against
impact and penetration.
3.1.14 hood, n—tight or loose-fitting respiratory inlet cov-
ering that completely covers the head and neck and may cover
portions of the shoulders.
3.1.15 immediately dangerous to life and health, IDLH,
n—any atmosphere that poses an immediate hazard to life or
immediate irreversible debilitating effects on health.
3.1.16 interior structural firefighting, n—physical activity
of fire suppression, rescue, or both, inside of buildings or
enclosed structures that are involved in a fire situation beyond
the incipient state (see 29 CFR 1910.155).
3.1.17 loose-fitting face piece, n—respiratory inlet covering
that is designed to form a partial seal with the face, does not
cover the neck and shoulders, and may or may not offer head
protection against impact and penetration.
3.1.18 metabolic equivalents, METs, n—unit of energy ex-
pended; one MET is 3.5 mL O2/kg/min and represents the
energy expended at rest.
3.1.18.1 Discussion—Standardized exercise protocols ex-
press energy expended in terms of multiples of resting meta-
bolic energy or METs.
3.1.19 negative pressure respirator, n—respirator in which
the air pressure inside the respiratory inlet covering is negative
during inhalation with respect to the ambient air pressure.
3.1.20 oxygen-deficient atmosphere, n—oxygen partial pres-
sure of 96 to 122 mm Hg shall be considered an oxygen-
deficient atmosphere that is not immediately dangerous to life
and health (IDLH).
3.1.20.1 Discussion—An oxygen partial pressure of 95 mm
Hg or less shall be considered IDLH. The oxygen deficiency
may be caused by a reduction in the normal 20.9 % oxygen
content by reduced total atmospheric pressure or any combi-
nation of reduced percentage of oxygen and reduced pressure.
3.1.21 physician or other licensed healthcare professional,
PLHCP, n—individual whose legally permitted scope of prac-
tice (that is, license, registration, or certification) allows them
to provide independently, be delegated the responsibility to
2
provide independently, or be delegated the responsibility to
provide some or all of the healthcare services required by 29
CFR 1910.134(e).
3.1.22 positive pressure respirator, n—respirator in which
the pressure inside the respiratory inlet covering is normally
positive with respect to ambient air pressure.
3.1.23 qualitative fit test, QLFT, n—pass/fail test that relies
on the subject’s sensory response to detect a challenge agent.
3.1.24 quantitative fit test, QNFT, n—fit test that uses an
instrument to measure face seal leakage.
3.1.25 respiratory inlet covering, n—that portion of a res-
pirator that connects the wearer’s respiratory tract to an
air-purifying or atmosphere-supplying respirator.
3.1.25.1 Discussion—They may be a face piece, helmet,
hood, or mouthpiece/nose clamp.
3.1.26 self-contained breathing apparatus, SCBA,
n—atmosphere-supplying respirator in which the respirable gas
source is designed to be carried by the user.
3.1.27 service life, n—time that a respirator provides ad-
equate protection to the wearer.
3.1.28 tight-fitting respiratory inlet covering, n—respirator
component designed to form a complete seal with the face or
neck.
3.1.28.1 Discussion—A half face piece (includes quarter
face piece, filtering face piece, and half face piece with
elastomeric face pieces) covers the nose and mouth; a full face
piece covers the nose, mouth, and eyes. Tight-fitting hoods seal
at the neck.
3.1.29 wearer seal check (namely, user seal check),
n—procedure conducted by the wearer to determine if a
tight-fitting respirator is properly donned.
3.2 Acronyms:
3.2.1 APR—air-purifying respirator
3.2.2 BP—blood pressure
3.2.3 CAD—coronary artery disease
3.2.4 DBP—diastolic blood pressure
3.2.5 EKG—electrocardiogram
3.2.6 IDLH—immediately dangerous to life and health
3.2.7 NIOSH—National Institute for Occupational Safety
and Health
3.2.8 PAPR—powered air-purifying respirator
3.2.9 PVC—premature ventricular contraction
3.2.10 SBP—systolic blood pressure
4. Significance and Use
4.1 This practice provides information and guidance to
PLHCPs to assist them in determining the medical suitability
of personnel for respirator use. It identifies the responsibility of
management to provide the PLHCP with supplemental infor-
mation before the PLHCP makes a recommendation concern-
ing an employee’s ability to use a respirator (9.1). Evaluators
shall use their clinical judgment in the application of these
 F3620 − 22
guidelines and require additional information or evaluation as
necessary to permit certification or classification for respirator
use.
4.2 Shall and Should—The provisions of this practice are
mandatory in nature when the word “shall” is used and
advisory in nature when the word “should” is used.
4.3 Exceptions—Users of this practice should be aware that
regulatory agencies may have requirements that are different
from this practice.
5. Respirator Characteristics
5.1 Air-Purifying Respirators (APRs):
5.1.1 General—APRs remove specific air contaminants by
passing ambient air through an air-purifying filter, cartridge, or
canister. APRs are either nonpowered or powered. APRs are
not approved for firefighting efforts.
5.1.2 Air-Purifying (Nonpowered) Respirators—Inhalation
through the filtering media and exhalation through the valve
depend only on the breathing action of the lungs. The maxi-
mum allowed inhalation and exhalation resistance depends on
the respirator type. For particulate-removing (particle filter)
respirators, inhalation resistances are less than 35 mm H2O and
exhalation resistances are less than 25 mm H2O. For gas/vapor-
removing (chemical cartridge) respirators, including those with
particle filters, inhalation resistances are less than 70 mm H2O
and exhalation resistances are less than 20 mm H2O. For gas
mask respirators, inhalation resistances are less than 85 mm
H2O and exhalation resistances are less than 20 mm H2O. All
resistances are measured at a maximum airflow of 85 L/min.
5.1.3 PAPRs—Powered units contain a blower to move the
air through the filtering media. Inhalation and exhalation
resistance are negligible similar to a continuous-flow air line
device. The weight of the blower varies from approximately 2
to 7 kg.
5.2 Atmosphere-Supplying Respirators:
5.2.1 General—Atmosphere-supplying respirators are either
self-contained or air line units. The SCBA is completely
portable. The air line apparatus requires the trailing of an air
hose from the wearer to the source of breathing air.
5.2.1.1 Atmosphere-supplying respirators operate in
continuous-flow, demand, or pressure-demand modes.
Continuous-flow respirators blow air continuously into the
mask. Demand-type apparatus require the wearer to inhale and
reduce the mask pressure below atmospheric pressure before
the regulator will supply air. (This is similar to inhaling
through an air-purifying device.) In a pressure-demand (posi-
tive pressure) device, a slight positive pressure is maintained in
the face piece at all times by the regulator. More air is admitted
to the mask as the positive pressure decreases during inhala-
tion. Exhalation resistances are greater than for demand de-
vices.
5.2.2 Open-Circuit SCBA—Open-circuit SCBA is available
in demand or pressure-demand devices. In open-circuit
devices, breathing air is supplied from a cylinder to the mask
and then dumped into the atmosphere on exhalation. The
nitrogen in the breathing air is excess weight that does not
contribute to the wearer’s metabolism. The maximum allowed
3
weight is 16 kg, although modern half-hour units may weigh
4.5 kg less. Significant reduction (up to 20 %) in work capacity
of the wearer can occur since the 16 kg load shall be carried.
Heavy work rates may be required during firefighting and
rescue situations while wearing SCBA.
5.2.2.1 Regulators on current SCBA may not meet the high
instantaneous demand of wearers at heavy work rates and so
may impair work output further. The increased exhalation
resistance of pressure-demand units may also degrade the
ability to perform heavy work.
5.2.3 Closed-Circuit SCBA—Closed-circuit SCBA is avail-
able in demand or pressure-demand devices. In closed-circuit
units (also known as rebreathers), oxygen is supplied from a
compressed gas, liquid, or chemical source. Exhaled air is
scrubbed of carbon dioxide and returned to the face piece.
Closed-circuit devices have a longer duration for their weight
than do open-circuit equipment. Breathing is into and out of a
bag rather than from a regulator. Oxygen concentrations may
range from 21 to 90 %.
5.2.4 Supplied-Air Respirators (SARs)—Supplied-air or air
line respirators are available as continuous-flow, demand, or
pressure-demand devices. All SARs require a trailing air hose
that limits movement about the workplace. Duration of use is
limited only by the air source and the metabolic work rate.
Exhalation resistance is equal to or lower than that of demand
equipment since the exhalation valve is held open by the
continuous outward flow of air. Demand and pressure-demand
versions of air line units have physiological effects similar to
the SCBA, except for the additional weight burden of the
SCBA.
6. Medical Evaluation Rationale
6.1 The effects of physical work effort, protective clothing,
temperature, humidity, and the physiological burden placed on
a worker using a respirator shall be considered during the
medical evaluation for respirator use. PLHCPs shall provide
reasonable assurance that a worker can endure these stressors
without adverse medical consequences and recommend any
limitations on respirator use related to the medical condition of
the employee or the workplace conditions in which the
respirator will be used.
7. Qualifications of Persons Who Conduct Medical
Evaluations to Determine Suitability to Use
Respiratory Protective Devices
7.1 Medical evaluation shall be performed by a PLHCP.
7.2 PLHCPs are expected to consult with an appropriate
physician when questions arise about an employee’s physical
condition and capability, such as those described in this
practice.
8. Evaluation Requirements
8.1 The industrial hygienist, safety professional, or other
employer representative shall provide the PLHCP with supple-
mental information before the PLHCP makes a recommenda-
tion concerning an employee’s ability to use a respirator. The
following supplemental information shall be provided (see Fig.
A2.2):
 F3620 − 22
8.1.1 The type and weight of the respirator to be used by the
employee, and this should include effort of breathing and
special features such as size, shape, bulk, full face, hood, and
so forth;
8.1.2 The duration and frequency of respirator use (includ-
ing use for rescue and escape);
8.1.3 The expected physical work effort;
8.1.4 Additional protective clothing and equipment to be
worn;
8.1.5 Temperature and humidity extremes that may be
encountered;
8.1.6 A copy of the written respiratory protection program;
and
8.1.7 A copy of 29 CFR Part 1910.134.
8.2 Extent of usage should be defined as:
8.2.1 On a daily basis (if so, state maximum hours a day of
expected use);
8.2.2 Occasionally, but probably more than once weekly (as
in maintenance worker); if so state maximum hours per week
of expected use;
8.2.3 Rarely (if so, state maximum hours per year of
expected use); and
8.2.4 For emergency situations only.
8.3 Special responsibilities should be defined, such as indi-
viduals who have responsibility for the safety of others and
consequently may be expected to have special physical capa-
bilities. This would include rescue workers, firefighters, secu-
rity personnel, and the like.
8.4 The estimated frequency for each type of “emergency
situation” that may pose an IDLH risk should be provided.
8.5 Other special environmental conditions (that is, exces-
sive heat, confined space usage, and hyperbaric or hypobaric
environments) should be identified. Additional requirements
for protective clothing should also be listed.
8.6 The above supplemental information need not be pro-
vided for subsequent medical evaluations if the information
remains the same and is transferred to the new evaluator.
8.7 The agents to which a worker will be exposed should be
identified for regularly scheduled work and during emergencies
when possible.
8.8 Based on this medical evaluation and the information
provided, the PLHCP shall certify whether the individual is
permitted to use a respirator under the circumstances de-
scribed. The physical demands of the work shall be the limiting
factor. The special characteristics of the respirator(s) to be used
for this work insofar as they significantly increase the work
demands while in use shall be considered.
8.8.1 In addition to the classification for respirator use, the
report to the employer representative should include any other
work limitations or restrictions found during evaluation, even
if they are not necessarily related specifically to respirator use.
8.8.2 The PLHCP shall classify the examinee in a category
as follows (see Fig. A2.1).
8.8.2.1 Class 1—No restriction on respirator use.
8.8.2.2 Class 2—Conditional respirator use permitted sub-
ject to specific use restrictions, medical evaluations, or treat-
4
ments. These work restrictions should be identified to permit a
decision by the supervisor or safety representative to determine
suitability for a specific task. Restrictions may include
moderate/light work only, no SCBA use, PAPR only, annual
medical evaluation, or age-specific medical evaluation.
8.8.2.3 Class 3—Permanent restriction from respirator use.
No respirator use permitted (permanently) under any circum-
stances. The reason should not be identified on the report to the
supervisor or the safety department or other groups responsible
for the respirator program.
8.8.2.4 Class 4—Temporary restriction from respirator use.
No respirator use permitted (temporary). Worker requires
additional medical evaluation or treatment, or both, and phy-
sician evaluation.
8.8.2.5 Class 5—Additional temporary or permanent non-
respirator work restrictions (for example, no heavy lifting, no
climbing, and no heat stress).
8.9 A written respiratory protection program shall include a
written worksite-specific procedure describing the medical
evaluation process for respirator users.
9. Medical History
9.1 A medical history (respirator questionnaire) should be
used to identify (see Fig. A2.3 for example):
9.1.1 Previously diagnosed diseases, particularly known
cardiovascular or respiratory diseases;
9.1.2 Psychological problems or symptoms including claus-
trophobia;
9.1.3 Problems associated with breathing during normal
work activities;
9.1.4 Past problems with respirator use;
9.1.5 Past and current usage of medication;
9.1.6 Any known physical deformities or abnormalities,
including those that may interfere with respirator use; and
9.1.7 Known current pregnancy.
9.2 The PLHCP shall review the medical questionnaire.
Conditions that may possibly disqualify personnel for respira-
tor use, as identified by a positive response on the respirator
questionnaire, shall be followed by an interview with a PLHCP.
9.2.1 If indicated, following an interview, the PLHCP shall
refer or perform an evaluation of the individual (see Fig. A2.1).
The PLHCP will determine the scope of the evaluation and
what testing, if any, shall be required to determine medical
suitability to use a respirator.
9.2.2 In certain cases following an evaluation, additional
medical tests, consultation, or diagnostic procedures (such as,
a cardiac EST, spirometry, an audiogram, and an ophthalmol-
ogy consultation) may be necessary to make a final determi-
nation (see Annex A1 and Fig. A2.1). Only the PLHCP’s
determination shall be communicated to the supervisor/
manager; no medical information shall be communicated.
10. Medical Evaluation
10.1 Frequency—An initial medical evaluation shall be
performed using a medical history (respirator questionnaire,
see Fig. A2.3) or interview and examination that obtain the
same information as the medical questionnaire. Additional
evaluations shall be required if: (1) the employee reports
 F3620 − 22
medical signs or symptoms that are related to the ability to use
a respirator; (2) a PLHCP, supervisor, or the respirator program
administrator informs the employer that an employee needs to
be reevaluated; (3) information from the respiratory protection
program including observations made during fit testing and
program evaluation indicates a need for employee reevalua-
tion; or (4) a change occurs in workplace conditions (for
example, physical work effort, protective clothing, and tem-
perature) that may result in a substantial increase in the
physiological burden placed on an employee.
10.1.1 In addition, a follow-up questionnaire or interview
should be used periodically to identify medical conditions that
develop after the initial evaluation. This questionnaire could be
administered before an annual fit test (see Fig. A2.4). The
frequency of this follow-up could be age specific, for example,
every five years up to age 35, then every two years until age 45,
and annually thereafter.
10.1.2 Annual evaluations for SCBA users of all ages shall
be required.
10.1.3 Following review of the periodic questionnaire,
interview, and/or limited medical testing, the PLHCP may
determine that certain individuals require additional evaluation
(such as all or part of the physical examination and testing
described in Fig. A2.1) and/or medical testing, consultation, or
diagnostic procedures.
10.2 General Considerations—The PLHCP’s evaluation of
suitability of the individual examinee for respirator use shall be
based on the unique medical status of the individual (regarding
the workload to be performed while wearing the respirator).
10.2.1 Following the initial or a subsequent evaluation, the
PLHCP may determine that periodic medical reevaluation
(examination, testing, or consultation) is appropriate for a
certain individual.
10.2.2 The PLHCP shall provide the worker/employee and
the employer with a written recommendation regarding the
worker’s medical ability to use a respirator (see Fig. A2.2). The
PLHCP shall also notify the worker/employee of any medical
conditions, actions recommended, and the frequency of neces-
sary periodic evaluations (see Fig. A2.5).
10.2.3 The following conditions shall be considered tempo-
rarily disqualifying for most respirator use. These conditions
may require medical evaluation or treatment and may result in
permanent restriction from respirator use. Additional commu-
nication with the PLHCP and monitoring of health status may
help to disposition workers with these conditions.
10.2.3.1 Facial conditions such as deformities or facial hair
that prevent tight-fitting respirators from making an acceptable
seal may disqualify the applicant from wearing a tight-fitting
respirator. A fit test is performed to determine whether facial
deformity will affect the respirator fit. A fit test shall not be
conducted if there is any hair growth between the skin and the
face piece sealing surface, such as stubble beard growth, beard,
mustache, or sideburns that cross into the respirator sealing
surface.
10.2.3.2 Acute respiratory diseases that are anticipated to
resolve (including acute pneumonia, acute bronchitis, and
acute asthma) may prevent respirator use.
5
10.2.3.3 “Moderate to severe” restrictive or obstructive
pulmonary disease or perfusion disorders may require further
evaluation. The worker’s medical history, physical
examination, and spirometry results may be used as a basis for
temporary disqualification pending further medical evaluation
(see Fig. A2.1). Spirometry may also be useful for medical
surveillance purposes with certain workplace exposures.
10.2.3.4 Symptomatic CAD, significant arrhythmias (for
example, PVCs, tachycardia, or bradycardia), or a history of
myocardial infarction may require further evaluation. If an
EKG is performed, it should be interpreted using informed
clinical judgment with consideration of the worker’s overall
health status.
10.2.3.5 The PLHCP, using clinical judgment, shall decide
if individuals with treated or untreated hypertension, individu-
als using cardiovascular medications, and individuals with
multiple risk factors or a single extreme risk factor require
further medical evaluation.
10.2.3.6 Workers with an SBP greater than or equal to 180
or a DBP greater than or equal to 110, treated or untreated,
shall be temporarily restricted from respirator use. Workers
with an SBP greater than or equal to 140 or a DBP greater than
or equal to 90 shall be referred for physician evaluation. The
PLHCP will disposition the worker after consideration of the
medical information provided and the work effort anticipated.
10.2.3.7 In cases in which the PLHCP has concerns about a
worker’s ability to use respiratory protective devices because
of abnormal pulmonary function testing (11.1 and Annex A3),
a history of CAD, obesity (BMI of greater than 35), or a
combination of these or other medical problems, the worker
may be medically cleared for respirator use at a known level of
work (light, moderate, or heavy) by use of an EST. The
demonstration of greater than or equal to 10 METs functional
capacity absent ischemia, arrhythmia, or abnormal BP response
on a physician-supervised EST is considered adequate for
clearance to perform most heavy physical work and to work in
heat stress environments (see 11.1 and Annex A1).
10.2.3.8 Neurological Disability—Certain neurological dis-
orders that affect movement or consciousness or both may be
aggravated by the work environment associated with respirator
use (heat, humidity, protective clothing, and strenuous work).
Workers with such a disorder shall be temporarily disqualified
pending physician evaluation.
10.2.3.9 Medications—PLHCPs shall use clinical judgment
to determine if an individual should be denied use of a
respirator because of medication use (including prescription
and non-prescription drugs) that may affect an employee’s
ability to perform his or her job. This decision may involve
communication with the PLHCP.
10.2.3.10 Psychological Conditions—The PLHCP shall de-
cide if an employee with a psychological condition that may
impair judgment or reliability should be disqualified (for
example, claustrophobia or severe anxiety). The decision may
involve communication with the PLHCP. The PLHCP may
recommend observed fit testing for the examinee.
10.2.3.11 Hearing should be adequate to ensure response to
instructions and alarm systems, or hearing deficiencies should
be otherwise accommodated. In certain work environments,
 F3620 − 22
olfaction may be an important sense to warn respirator users of
poor face seal or other causes of respirator failure. Workers
who report trouble smelling odors may require work restriction
or additional medical evaluation (which may include olfactory
testing), and these workers may be unsuitable for fit testing
methods that rely on odor detection. Workers shall have
adequate vision to perform their assigned job duties.
10.2.3.12 If a worker has suffered a sudden loss of con-
sciousness or response capability, a physician shall determine
if the employee may use a respirator.
11. Special Testing
11.1 Spirometry or EST may be used if the PLHCP needs
information in addition to a history and physical. Spirometry
results do not in themselves indicate fitness or lack of fitness to
use a respirator. For accurate assessment, spirometry should be
performed in accordance with the most recent recommenda-
tions of the American Thoracic Society/European Respiratory
Society (ATS/ERS) and the American College of Occupational
and Environmental Medicine (see Annex A3).
12. Keywords
12.1 physician or other licensed healthcare professional;
PLHCP; respirator user; respiratory protection program

6
 F3620 − 22
ANNEXES
(Mandatory Information)
A1. EXERCISE STRESS TESTING
A1.1 Clinical exercise testing, or the EST, is a useful test for
evaluating the functional capacity (work capacity) of users of
industrial respirators, as respiratory reserve is normally greater
than circulatory system reserve and cardiac disease is common
in working populations (1).4 Cardiac disease is a common
cause of sudden incapacity and decreased functional capacity.
For normal humans, it appears there is no single exercise-
limiting factor; the heart with contributions of muscle, rather
than lungs and blood, is largely responsible for exercise
limitations, training effects, and differences in exercise capac-
ity between people (2).
A1.2 The EST is a convenient means of determining exer-
cise tolerance and precipitating symptoms and signs in a
controlled environment using a standard protocol. Standard-
ized protocols, reduced equipment costs, and computerized
interpretations have greatly enhanced the practicality and
availability of this testing. Observations of heart rate are easily
available data to compare performance on an EST with
demands of job activities. At submaximal workloads, the
relationship between heart rate and oxygen uptake (workload)
is almost linear (3).
A1.3 Maximal testing with the aim of establishing safe
levels of exercise or work performance can be performed on
any person and aerobic capacity reported as METs (1 MET =
metabolic equivalent = energy expended at rest = 3.5 mL
O2/kg/min) (3).
A1.4 It is prudent to perform selectively supervised EST in
respirator users who are expected to engage in heavy work if
the evaluating PLHCP suspects deconditioning or coronary
disease on the basis of signs, symptoms, or risk factors. EST
4
The boldface numbers in parentheses refer to a list of references at the end of
this standard.
7
for cardiovascular fitness may be necessary, especially if the
work requires strenuous exertion, heat stress will be present, or
a clinical indication of a cardiovascular abnormality is present.
The use of respirators in conjunction with water-impermeable
protective clothing can impose significant thermal stress. Such
situations occur in the hazardous waste, nuclear, and other
industries. EST may also be advisable in the first two situations
for workers older than 45 years of age regardless of clinical
status. Resting EKGs are not predictive of risk from respirator
use during exertion (4).
A1.5 EST requires the active cooperation and informed
consent of the participant. Stress testing may not detect
significant coronary disease, especially in asymptomatic work-
ers (5). And in young, healthy individuals false positives may
occur. In such cases, there should be a way to quickly obtain
confirmation using a technique such as a radionuclide stress
imaging. Although EST cannot reliably identify all persons at
risk of an acute event, it may increase the margin of safety.
Workers should be evaluated on an individual basis and
additional testing such as imaging studies may also be recom-
mended for those considered to be at higher risk (3).
A1.6 Supervision during EST should be provided by a
physician with appropriate training and experience (6).
A1.7 Many protocols and types of equipment (treadmill,
cycle ergo meter) are available to perform EST. The choice of
equipment and protocol should be the decision of the testing
physician.
A1.8 Workers are less likely to have clinically significant
CAD if they achieve a level of 10 METs functional capacity (7)
with absence of arrhythmia, abnormal blood pressure response,
or ischemia and are usually capable of performing heavy
physical work and work in high-heat stress situations (8).
 F3620 − 22

A2. RESPIRATOR MEDICAL EXAMINATION FORMS

FIG. A2.1 Respirator Medical Examination Form—Temporary Disqualification Criteria

8
 F3620 − 22

FIG. A2.2 Request for Medical Clearance for Respirator Use Questionnaire

9
 F3620 − 22

FIG. A2.3 Medical Questionnaire for Respirator Users (Initial)

10
 F3620 − 22

FIG. A2.3 Medical Questionnaire for Respirator Users (Initial) (continued)

11
 F3620 − 22

FIG. A2.4 Medical Questionnaire for Respirator Users (Periodic)

12
 F3620 − 22

FIG. A2.5 Employee Copy of PLHCP’s Written Recommendation

13
 F3620 − 22
A3. SPIROMETRY
A3.1 Introduction
A3.1.1 Spirometry is the most frequently performed test of
ventilatory function. However, since it is effort dependent and
requires attention to detail, failure to follow current American
Thoracic Society (ATS), ATS/European Respiratory Society
(ERS), and American College of Occupational and Environ-
mental Medicine (ACOEM) guidelines may lead to incorrect
test results. The below-referenced ATS and ATS/ERS state-
ments on equipment and test performance (9-13), interpretation
of results (10, 11, 14), and screening for respirator use (15) are
recommended as guidance. ACOEM statements on spirometry
in the occupational setting are also recommended specifically
for the occupational setting (16, 17). Since ATS, ATS/ERS, and
ACOEM spirometry statements are periodically updated, for
example, in 2005, 2019, and 2020, users should consult recent
versions of the ATS/ERS spirometry statements and the
ACOEM guidelines. OSHA has also developed guidance on
Spirometry Testing in Occupational Health Programs: Best
Practices for Healthcare Professionals (18) and updated 29
CFR 1910.143 Cotton Dust Technical Appendix D in 2019
(19).
A3.1.2 Spirometry reports are medical records required to
be saved and protected as confidential medical information for
30 years after termination of employment. OSHA’s letter of
interpretation (20) on this topic is available at https://
www.osha.gov/laws-regs/standardinterpretations/2019-09-18.
A3.2 Specific Criteria
A3.2.1 Spirometry is not routinely required for medical
clearance of respirator users. The respiratory system’s large
reserve permits most healthy workers to tolerate the small
respiratory impact of many respirators. However, moderate or
severe reduction of ventilatory capacity may limit a subject’s
ability to use a respirator. “In the absence of other factors
limiting the worker’s overall ability to tolerate the demands of
the job and the respiratory protective equipment, FEV1 (and
FVC) of 60 % or greater of the predicted value suggest that a
trial of respirator use is allowable. For light duty work using
low-resistance respirators, even lower levels of function may
not be disqualifying, but a more thorough clinical evaluation
should be done (15).” Because of their variability, forced
expiratory flow rates (FEF25-75 and instantaneous flows) should
not be used in the evaluation of medical fitness for respirator
use.
A3.2.2 The ATS recommends spirometry testing for: (1)
workers >45 who use SCBA with strenuous exertion, (2)
younger workers using SCBA with strenuous exertion who
report respiratory symptoms or have abnormalities on the
14
screening questionnaire, (3) all respirator users >55, and (4)
workers reporting respiratory symptoms with the level of
exertion required by their job (15).
A3.2.3 All ATS, ATS/ERS, ACOEM, and OSHA recom-
mendations and the original and updated cotton dust standard
specify that spirometer accuracy should be checked daily. For
flow-type spirometers, which are the majority of those now
available, these checks are performed with a calibrated 3 L
syringe injected very quickly over 0.5 s, at medium speed over
3 s, and very slowly over 6 s to test the spirometer’s accuracy
when testing patients whose exhalations occur with a variety of
expiratory flow rates. The reports from the calibration checks
should be saved indefinitely to support the accuracy of work-
ers’ spirometry test results.
A3.2.4 When testing a subject, the technician should de-
scribe and demonstrate the maximal inspiration (to total lung
capacity), hard fast initial blast, and complete recording of the
maneuver and enthusiastically coach the subject. The goal is to
record at least three “acceptable” curves (as defined by the
ATS/ERS) with up to eight attempts if necessary, achieving
repeatability (“reproducibility”) for both the FVC and the
FEV1. The largest FVC and FEV1 are reported from the
acceptable curves even if they are not from the same maneuver,
and FVC and FEV1 are corrected to body temperature (BTPS).
Spirometry technicians should be highly motivated to conduct
good tests and trained so that they can judge the subject’s
degree of effort and cooperation. ACOEM, ATS/ERS, and
OSHA recommend or require that technicians initially com-
plete a NIOSH-approved (or similar) spirometry training
course and periodically attend spirometry refresher courses (9,
12, 13, 16, 17). Successful completion of NIOSH-approved
courses is required by the OSHA cotton dust and respirable
crystalline silica standards (19, 21) as well as the NIOSH Coal
Worker Health Surveillance Program (CWHSP) (22).
A3.2.5 Spirometry test results are interpreted by comparing
the observed FVC and FEV1 and their ratio, FEV1/FVC%, with
predicted average values and lower limits of normal (LLN)
derived from reference populations of non-smokers (14). The
goal is to determine whether the worker’s results fall within the
normal range or below it, indicating possible respiratory
impairment. At the present time, both ACOEM and ATS/ERS
(11, 14, 16) recommend use of the NHANES III (23) prediction
equation for occupational testing unless other prediction equa-
tions are required by applicable regulations. A flow chart for
interpreting results following ATS/ERS recommendations is
included in the OSHA guidance and the ACOEM statement
(16, 18).
 F3620 − 22
APPENDIX
(Nonmandatory Information)
X1. PURPOSE OF STANDARD
X1.1 This is the third standard to deal with this subject.
AIHA/ANSI Z88.6–2006 provided many details and updates
that were lacking in the initial ANSI Z88.6–1984 statement.
This current revision updates the standard to conform with
recent respirator, medical, and spirometry developments. The
purpose of this standard is to incorporate this newer informa-
tion and present a process that meets, and in many areas
exceeds, the minimum requirements of OSHA’s 29 CFR
1910.134 and:
X1.1.1 Includes all the questions required by the OSHA
respirator questionnaire as well as additional questions to
assess the risk of cardiac disease;
X1.1.2 Recommends physician review of all cases that fall
outside certain parameters; and
X1.1.3 Considers the physiological demand of the type of
work to be performed and type of respirator for which approval
is granted.
X1.2 The Committee has made the following determina-
tions regarding the new standard that:
X1.2.1 Any medical professional authorized to evaluate
respirator use should be required to know the physiological
demands associated with varying types of respirators;
X1.2.2 Impact of safe and reliable work performance on
fellow workers and the public should be considered;
X1.2.3 Impact of medical factors on job performance ex-
clusive of respirator use should be considered;
X1.2.4 Conditional approval may be granted in appropriate
cases;
X1.2.5 Periodic medical questionnaire before annual respi-
rator fit testing should be administered;
REFERENCES
(1) “Evaluations of Impairment/Disability Secondary to Respiratory
Disorders,” Official Statement, American Thoracic Society, adopted
March 1986.
(2) ATS/ACCP Statement on Cardiopulmonary Exercise Testing, adopted
by the American Thoracic Society (ATS) on March 1, 2002 and the
American College of Chest Physicians (ACCP) on November, 1,
2002.
(3) Temte, J. V., “Cardiovascular Conditions and Worker Fitness and
Risk,” Occupational Medicine: State of the Art Reviews, Vol 3, No. 2,
1988, pp. 241–254.
(4) Harber, P., et al.,“Respiratory Protection Guidelines,” American
Journal of Respiratory and Critical Care Medicine, Vol 154, No. 4,
1996, pp. 1153–1165.
15
X1.2.6 Clinical EST can be a useful test to evaluate func-
tional capacity but is not necessarily required to make a
respirator medical clearance determination;
X1.2.7 Respiratory reserve is normally greater than circula-
tory system reserve and cardiac disease is more common as a
disqualifier than pulmonary disease;
X1.2.8 Routine use of spirometry to determine the suitabil-
ity of individuals to use respiratory protective devices is not
required, although pulmonary function data (including aggre-
gate data) may be an important surveillance measure of
response to worker exposure;
X1.2.9 Workers are less likely to have clinically significant
CAD and be heat intolerant if they achieve a negative EST to
10 METs;
X1.2.10 Specific blood pressure, body weight, and pulmo-
nary function values will require physician consideration,
evaluation, and/or medical testing;
X1.2.11 Conservative definition of “heavy” work as sug-
gested by OSHA continues to be used;
X1.2.12 Concise statement regarding facial hair be in-
cluded;
X1.2.13 Workers using contact lenses and workers with
perforated tympanic membranes should not be routinely ex-
cluded;
X1.2.14 Chest X-ray should not be used routinely to deter-
mine suitability to use respirators; and
X1.2.15 Spirometry should be interpreted in accordance
with the recommendations of the American Thoracic Society
(ATS) and the American College of Occupational and Envi-
ronmental Medicine (ACOEM). ATS and ACOEM recommen-
dations for performing spirometry tests should be considered as
useful guidance by evaluators.
(5) Gibbons, R. J., Balady, G. J., Beasley, J. W., Bricker, J. T., Duvernoy,
W. F., et al., “ACC/AHA Guidelines for Exercise Testing, Report of
the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines(Committee on Exercise Testing),”
Journal of the American College of Cardiology, Vol 30, No. 1, 1997,
pp. 260–311.
(6) Rodgers, G. P., Ayurum, J. Z., Balady, G. J., et al., “American College
of Cardiology/American Heart Association Clinical Competence
Statement on Stress Testing: A Report of the American College of
Cardiology/American Heart Association/American College of
Physicians,” American Society of Internal Medicine Task Force on
Clinical Competence Circulation, Vol 102, No. 14, 2000, pp.
1726–1738.
 F3620 − 22
(7) ACSM’s Guidelines for Exercise Testing and Prescriptions, 7th
edition, American College of Sports Medicine, M. H. Whaley, ed.,
Lippincott Williams & Wilkins, Baltimore, 2006.
(8) “Criteria for a Recommended Standard Occupational Exposure to Hot
Environments,” Revised Criteria, DHHS (NIOSH)Publication No.
86-113, 1986.
(9) Graham, B. L., Steenbruggen, I., Miller, M. R., et al., “Standardization
of Spirometry 2019 Update. An Official American Thoracic Society
and European Respiratory Society Technical Statement,” American
Journal of Respiratory and Critical Care Medicine, Vol 200, No. 8,
2019, pp. e70–e88.
(10) Townsend, M. C.,“The American Thoracic Society/European Respi-
ratory Society 2019 Spirometry Statement and Occupational Spirom-
etry Testing in the United States,” American Journal of Respiratory
and Critical Care Medicine, Vol 201, No. 8, 2020, pp. 1010–1011.
(11) Graham, B. L. and Steenbruggen, I., “Reply to Townsend: The
American Thoracic Society/European Respiratory Society 2019
Spirometry Statement and Occupational Spirometry Testing in the
United States,” American Journal of Respiratory and Critical Care
Medicine, Vol 201, No. 8, 2020, p. 1012.
(12) Miller, M. R., et al., “Standardisation of Spirometry,” European
Respiratory Journal, Vol 26, No. 2, 2005, pp. 319–338.
(13) Miller, M. R., et al., “General Considerations for Lung Function
Testing,” European Respiratory Journal, Vol 26, No. 1, 2005, pp.
153–161.
(14) Pellegrino, R., et al., “Interpretative Strategies for Lung Function
Tests,” European Respiratory Journal, Vol 26, No. 5, 2005, pp.
948–968.
(15) Harber, P., Barnhart, S., Boehlecke, B. A., et al., “Respiratory
Protection Guidelines. This official statement of the American
Thoracic Society was adopted by the ATS Board of Directors, March
1996,” American Journal of Respiratory and Critical Care
Medicine, Vol 154, No. 4, Part 1, 1996, pp. 1153–1165.
(16) Townsend, M. C.,“Spirometry in Occupational Health—2020,”
Journal of Occupational and Environmental Medicine, Vol 62, No.
5, 2020, pp. e208–e230.
(17) Townsend, M. C. and Graham, B. L., “Impact of New Occupational
and Clinical Standards on Spirometry,” Journal of Occupational and
Environmental Medicine, Vol 62, No. 5, 2020, pp. e231–e232.
(18) Occupational Safety and Health Administration, “Spirometry Testing
in Occupational Health Programs: Best Practices for Healthcare
Professionals,” OSHA 3637:2013, available at http://www.osha.gov/
Publications/OSHA3637.pdf.
(19) Occupational Safety and Health Administration, Cotton Dust Stan-
dard Update: 1910.1043, 2019, available at https://www.ecfr.gov/
current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-Z/
section-1910.1043.
(20) Occupational Safety and Health Administration, Letter of Interpre-
tation from Patrick J. Kapust to Mary C. Townsend, Sept. 18, 2019,
available at https://www.osha.gov/laws-regs/standardinterpretations/
2019-09-18.
(21) Occupational Safety and Health Administration, Regulations(Stan-
dards 29 CFR 1910.1053, 1915.1053, and 1926.1153), 2016, avail-
able at: https://www.osha.gov/laws-regs/regulations/
standardnumber/1910/1910.1053; https://www.osha.gov/laws-regs/
regulations/standardnumber/1915/1915.1053; and https://
www.osha.gov/laws-regs/regulations/standardnumber/1926/
1926.1153.
(22) NIOSH Coal Worker Health Surveillance Program (CWHSP), 42
CFR 37, Specifications for Medical Examinations of Coal Miners,
available at: https://www.ecfr.gov/cgi-bin/retrieveECFR?&-
n=42y1.0.1.3.21&r=PART&ty=HTML.
(23) Hankinson, J. L., Odencrantz, J. R., and Fedan, K. B., “Spirometric
Reference Values from a Sample of the General U.S. Population,”
American Journal of Respiratory and Critical Care Medicine, Vol
159, No. 1, 1999, pp. 179–187.

ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned
in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk
of infringement of such rights, are entirely their own responsibility.

This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and
if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards
and should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of the
responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should
make your views known to the ASTM Committee on Standards, at the address shown below.

This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,
United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the above
address or at 610-832-9585 (phone), 610-832-9555 (fax), or service@astm.org (e-mail); or through the ASTM website
(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http://www.copyright.com/

16