ASTM F3568-23

• Abstract:

  SIGNIFICANCE AND USE; 3.1 In keeping with 1.1, commercial human spaceflight companies should follow the guidelines recommended by this document. These guidelines may be tailored to fit each company's specific spaceflight systems, operational procedures, safety standards, and risk profiles. ; 3.2 Companies currently are required under Title 51 USC § 50905(b) (5) to inform spaceflight participants about the mission-related risk, but the specific risk of certain medical conditions has yet to be determined. The SFP medical standards and guidelines in this guide shall be considered the minimum recommended, and governmental agencies and operators have the option for additional medical and operational constraints.; SCOPE; 1.1 This guide provides a consensus set of Space Flight Participant (SFP) acceptance guidelines that will serve as advice to commercial human spaceflight operators as they develop their own medical programs for suborbital flights. ; 1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. ; 1.3 FAA regulatory authority: In 2004 Congress granted the FAA the authority to oversee the safety of the emerging commercial human space flight industry, but limited its rulemaking authority. To ensure the industry had an ample learning period to develop and innovate, Congress prohibited the FAA from issuing any regulations governing the design or operation of a launch vehicle intended to protect the health and safety of crew and space flight participants unless there was a death, serious injury, or close call. The original prohibition expired in 2012, but Congress extended it to 2015, then extended it again to 2016, and finally to October 1, 2023. SFP medical requirements are not under the Amendments Act of 2004 current moratorium that will expire in 2023. ; The Secretary of the US Department of Transportation (USDOT) has authority to issue regulations regarding SFP medical requirements under Title 51 USC § 50905 (b) (6): ; (A) The Secretary may issue regulations requiring space flight participants to undergo an appropriate physical examination prior to a launch or reentry under this chapter. This subparagraph shall cease to be in effect three years after the date of enactment of the Commercial Space Launch Amendments Act of 2004. ; (B) The Secretary may issue additional regulations setting reasonable requirements for space flight participants, including medical and training requirements. Such regulations shall not be effective before the expiration of 3 years after the date of enactment of the Commercial Space Launch Amendments Act of 2004. ; However, USDOT has declined to exert this authority thus far. ; 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. ; 1.5 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.

• Status: Published
• Publication Date: 31-Aug-2023
• ICS: 49.020 - Aircraft and space vehicles in general
• Technical Committee: F47 - Commercial Spaceflight
• Drafting Committee: F47.01 - Occupant Safety

Overview

ASTM F3568-23: Standard Guide for Medical Qualifications for Suborbital Vehicle Passengers establishes consensus guidelines for assessing the medical qualifications of space flight participants (SFPs) in commercial suborbital spaceflight. Developed by ASTM International, this guide supports commercial human spaceflight operators as they design and implement medical screening and evaluation programs for passengers. It is intended to ensure appropriate health, safety, and operational readiness standards while allowing operators to tailor their processes to specific mission profiles, vehicle systems, and risk management needs.

This standard aligns with internationally recognized principles for the development of standards and serves as a reference document for industry best practices, complementing the regulatory framework set forth by relevant authorities such as the Federal Aviation Administration (FAA) and the U.S. Department of Transportation (USDOT).

Key Topics

• Space Flight Participant (SFP) Medical Screening: The guide outlines key elements of medical screening, including preflight questionnaires, physical examinations, and laboratory testing. These processes are designed to identify medical conditions that may present increased risk during suborbital flight.

• Operational Readiness Assessment: Beyond routine health checks, the guide emphasizes the evaluation of SFPs’ capabilities to perform tasks critical for safety, such as vehicle ingress/egress, harness use, and emergency procedures.

• Minimum Recommended Standards: The medical guidance outlined constitutes a baseline, recommending that commercial operators may exceed these standards based on their unique operational contexts.

• Risk Disclosure and Mitigation: In accordance with Title 51 USC § 50905, operators are required to inform SFPs of known mission risks. The standard advises operators to consider conditions that may impair safety or mission success and recommends strategies to mitigate such risks, including additional medical consultation and targeted training.

• Tailored Evaluations: Each operator retains discretion to adapt the screening and acceptance criteria, in consultation with aerospace medicine specialists, to their particular vehicles, mission profiles, and passenger needs.

• Post-Flight Medical Debrief: To enhance industry knowledge and participant safety, the guide recommends post-flight medical reviews to assess any health effects resulting from spaceflight.

Applications

• Commercial Human Spaceflight Operators: This standard serves as a practical framework for developing and refining medical acceptance and risk management protocols for suborbital flight participants. By adopting ASTM F3568-23, operators can better fulfill regulatory and safety obligations while providing transparency and assurance to passengers.

• Aerospace Medicine Specialists and Health Professionals: Medical professionals responsible for assessing SFPs will find detailed guidance on evaluating suitability for suborbital missions, including advice on screening for conditions such as anxiety, cardiovascular disease, or respiratory disorders that may be particularly relevant to the spaceflight environment.

• Regulators and Policy Makers: While direct regulatory authority over medical requirements for SFPs has not been fully exerted by USDOT or FAA, this standard provides a basis for future regulation and supports voluntary compliance with best practices.

• Passengers and Spaceflight Participants: Individuals preparing for suborbital space travel can reference this guide to understand the medical screening process, potential disqualifying conditions, and the importance of operational readiness in ensuring a safe and successful journey.

Related Standards

The ASTM F3568-23 standard draws upon a range of industry sources and existing guidelines, including:

• Aerospace Medical Association Position Papers
• FAA Recommendations on Commercial Spaceflight Medical Certification
• International Space Station (ISS) Medical Standards
• Other ASTM Standards for Commercial Human Spaceflight such as those addressing occupant safety

For robust SFP medical qualification and risk management, operators and professionals are also encouraged to consult related work from the World Trade Organization Technical Barriers to Trade (TBT) Committee, as referenced in the development of this standard.

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Keywords: commercial spaceflight, suborbital passengers, space flight participant, medical screening, aerospace medicine, SFP medical standards, passenger safety, operational readiness, risk mitigation, ASTM F3568-23

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: F3568 − 23
Standard Guide for
Medical Qualifications for Suborbital Vehicle Passengers
This standard is issued under the fixed designation F3568; 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 1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This guide provides a consensus set of Space Flight
responsibility of the user of this standard to establish appro-
Participant (SFP) acceptance guidelines that will serve as
priate safety, health, and environmental practices and deter-
advice to commercial human spaceflight operators as they
mine the applicability of regulatory limitations prior to use.
develop their own medical programs for suborbital flights.
1.5 This international standard was developed in accor-
1.2 Units—The values stated in SI units are to be regarded
dance with internationally recognized principles on standard-
as standard. No other units of measurement are included in this
ization established in the Decision on Principles for the
standard.
Development of International Standards, Guides and Recom-
1.3 FAA regulatory authority: In 2004 Congress granted the mendations issued by the World Trade Organization Technical
FAA the authority to oversee the safety of the emerging Barriers to Trade (TBT) Committee.
commercial human space flight industry, but limited its rule-
making authority. To ensure the industry had an ample learning
2. Terminology
period to develop and innovate, Congress prohibited the FAA
2.1 Definitions:
from issuing any regulations governing the design or operation
2.1.1 aerospace medicine specialist, n—a physician who is
of a launch vehicle intended to protect the health and safety of
residency trained and board certified in the specialty of
crew and space flight participants unless there was a death,
Aerospace Medicine, or a physician who is otherwise qualified
serious injury, or close call. The original prohibition expired in
by virtue of knowledge, training, and experience.
2012, but Congress extended it to 2015, then extended it again
2.1.2 flight crew equipment, n—any personal protective
to 2016, and finally to October 1, 2023. SFP medical require-
equipment necessary for the safe conduct of the flight. This can
ments are not under the Amendments Act of 2004 current
include pressure suits, helmets, parachute assemblies, medical
moratorium that will expire in 2023.
systems, emergency breathing devices, or other equipment
The Secretary of the US Department of Transportation
required for safe operations.
(USDOT) has authority to issue regulations regarding SFP
medical requirements under Title 51 USC § 50905 (b) (6):
2.1.3 medical, adj—the term ‘medical’ as used in this
(A) The Secretary may issue regulations requiring space
document is to be interpreted broadly and includes the terms
flight participants to undergo an appropriate physical exami-
‘physical,’ ‘physiological,’ and ‘psychological.’
nation prior to a launch or reentry under this chapter. This
2.1.4 operational readiness, n—the continuous process of
subparagraph shall cease to be in effect three years after the
assessing the SFP’s demonstrated capabilities to safely perform
date of enactment of the Commercial Space Launch Amend-
tasks related to the spaceflight such as vehicle ingress and
ments Act of 2004.
egress, to utilize all safety equipment including but not limited
(B) The Secretary may issue additional regulations setting
to seat harnesses, and to be in an optimal state of health on the
reasonable requirements for space flight participants, including
day of the spaceflight as determined by the Operator’s flight
medical and training requirements. Such regulations shall not
environment and mission specifics. This assessment starts with
be effective before the expiration of 3 years after the date of
first contact between the SFP and the Operator and continues
enactment of the Commercial Space Launch Amendments Act
until the time of launch.
of 2004.
2.1.5 payload specialist (PS), n—an individual that flies for
However, USDOT has declined to exert this authority thus
the purpose of conducting scientific investigations on
far.
themselves, other SFPs, or scientific payloads or performing
technology or engineering evaluations. For medical standards
This guide is under the jurisdiction of ASTM Committee F47 on Commercial
purposes, this is a subset of the space flight participant
Spaceflight and is the direct responsibility of Subcommittee F47.01 on Occupant
Safety. category.
Current edition approved Sept. 1, 2023. Published September 2023. DOI:
10.1520/F3568–23. 2.1.5.1 Discussion—While most SFPs would fly only one
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3568 − 23
time per day, it is possible that payload specialists could fly on between launch and entry have not been accomplished before,
multiple missions in a single day or on repetitive days. Payload and caution will be indicated until an experience base is
specialists normally are screened as space flight participants acquired.
(SFPs), but certain operations or operators may require addi-
4.1.3 Time Limit in Spacecraft—Time within the spacecraft
tional medical screening.
will be defined as the interval from the SFPs being secured
2.1.6 space flight participant, (SFP), n—an SFP is a non- within the space craft before flight to door(s) open upon return.
flightcrew member that participates in suborbital spaceflight
The time requirement to complete a flight will be short enough
but has no safety-related responsibilities for the vehicle or the to avoid negatively impacting a SFP medical condition, inter-
conduct of the flight.
rupting medical mitigation or treatment needs, and take human
physiological needs into consideration (refer to 4.3).
2.1.6.1 Discussion—Suborbital space flights are operation-
4.1.4 Radiation Limits—The ionizing radiation effective
ally different than the typical experience of passengers on a
dose shall not exceed the yearly commercial airline passenger
commercial airliner or other modes of transportation such as
dose defined as no more than 1 mSv/year.
cars or trains. SFPs may not be physically separated from the
flightcrew, are exposed to increases in gravitational forces
4.2 Guidelines for Screening Suborbital SFPs—A preflight
beyond commercial aircraft flight and may be exposed to
evaluation of SFPs shall be performed and include a statement
off-nominal cabin environmental parameters. They must inte-
by the Operator that summarizes the expected environment and
grate into, or be compatible with, required flightcrew
associated risks and hazards during the spaceflight, the medical
equipment, restraint systems, and vehicle egress systems. SFPs
conditions the Operator deems to be incompatible with space-
may be flying for pleasure or could be scientists, engineers, or
flight or that warrant consultation with medical specialists, and
others conducting microgravity research, performing technol-
any tasks or activities that the SFP will be required to perform
ogy demonstrations, or providing medical care/monitoring for
including operational readiness requirements. The contents of
other SFPs.
this evaluation shall be developed in consultation with an
aerospace medicine specialist and provided to the SFP. The
3. Significance and Use
SFP shall complete a medical questionnaire and return it to the
Operator for their review. A physical exam shall be performed
3.1 In keeping with 1.1, commercial human spaceflight
by a licensed physician and will include additional testing
companies should follow the guidelines recommended by this
including laboratory testing and imaging analysis as appropri-
document. These guidelines may be tailored to fit each com-
ate. During training and preflight operations, the Operator shall
pany’s specific spaceflight systems, operational procedures,
perform an evaluation of SFP operational readiness that is
safety standards, and risk profiles.
specific to the Operator’s flight profile and environment.
3.2 Companies currently are required under Title 51 USC §
The content and extent of the medical questionnaire, physi-
50905(b) (5) to inform spaceflight participants about the
cal examination, and any additional tests shall be related to
mission-related risk, but the specific risk of certain medical
each Operator’s flight profile. The suggested contents of the
conditions has yet to be determined. The SFP medical stan-
medical questionnaire and physical examination are shown in
dards and guidelines in this guide shall be considered the
Tables 1 and 2 and may be modified by each Operator to
minimum recommended, and governmental agencies and op-
account for differences in their specific flight profiles. The
erators have the option for additional medical and operational
preflight evaluation shall be reviewed by an aerospace medi-
constraints.
cine specialist, and ideally should be performed by an aero-
space medicine specialist.
4. Spaceflight Participant Medical Acceptance
4.2.1 Timing of Medical Screening—The SFP’s age and
Guidelines—Suborbital
medical complexity shall be considered in determining the
4.1 Reference Mission—Guidelines for operators for subor-
timing for medical screening. Generally, initial screening
bital SFPs assume that the spacecraft will normally provide a
should be performed within six months before the SFP’s
shirt-sleeve cabin environment with the appropriate
suborbital flight. Follow-up medical screening, including up-
temperature, pressure (not less than 75.3 kPa equivalent to a
dating the medical history and physical examination, may be
maximum pressure altitude of 2438 m), and breathable atmo-
advisable before initiation of training, analog activities, or
sphere.
spaceflight. Evaluation for operational readiness of the SFP by
the Operator typically begins with training activities and
4.1.1 G-Profile—Acceleration in suborbital spacecraft
should not exceed +6Gx, +1Gy, and +4Gz. Brief exposures continues through preflight activities including vehicle ingress
and preparation for launch.
above these levels may occur, are acceptable for suborbital
flight, and would not be automatically considered as indicative
4.2.2 Self-Certification—SFPs shall indicate to the examin-
of an orbital flight.
ing physician and the Operator if they know or have reason to
4.1.2 Number of Flights per Day—Guidelines will assume know of a medical condition that would impair their ability to
SFPs will generally only participate in one suborbital flight per safely perform any of the space-flight tasks required of the SFP
day. Payload specialists or flight crew may make multiple during all mission phases, including vehicle ingress and egress,
flights per day. Repeated flights to the acceleration limits listed high-g and microgravity operations, seat/restraint ingress and
above and with approximately 4 min of microgravity exposure egress, and off-nominal or emergency procedures.
F3568 − 23
4.2.3 Review of Results of Medical Screening—If the phy- 4.3.10 May jeopardize the success of one or more SFP’s
sician administering the questionnaire, performing the physical individual mission.
examination, or ordering the additional tests, or combinations
4.4 Risk Mitigation Strategies:
thereof, is not an aerospace medicine specialist, the Operator
4.4.1 In the event a prospective suborbital SFP does not
shall seek consultation from an aerospace medicine specialist
meet the recommended guidance criteria in 4.2 and 4.3, a
in determining suitability for suborbital spaceflight mission(s).
mitigation strategy may be considered. The Operator shall
The Operator should recommend the SFP complete any addi-
ensure that the condition and mitigation process will not impair
tional medical evaluation recommended by the aerospace
the ability of the SFP to safely perform activities required for
medicine specialist. The Operator shall retain final authority
the flight, including emergency egress from the spacecraft, and
regarding the SFP’s ability to
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