ASTM F3764-25

1.1 This guide provides a consensus set of participant acceptance guidelines that can serve as advice to commercial operators as they develop their own medical programs in support of orbital human commercial spaceflight operations. The medical qualifications for suborbital commercial participants have been previously published in another ASTM standard (Guide F3568).

1.2 Units—The values stated in SI units are to be regarded as the 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 (SFP) 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. Spaceflight participant (SFP) medical requirements are not under the Amendments Act of 2004 current moratorium though these may be regulated by the Secretary of the US Department of Transportation (USDOT) starting January 1, 2025.

1.4 The Secretary has authority to issue regulations regarding SFP medical requirements under Title 51 USC § 50905 (b) (6):

However, USDOT has declined to exert this authority thus far.

1.5 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.

1.6 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.

4.1 Commercial companies will have the opportunity to incorporate this guide into their operations, tailoring it to meet each company’s specific requirements including, but not limited to, vehicle-specific flight parameters, safety standards, risk profiles, and consumer protection criteria.

4.2 Federal regulations, under 14 CFR § 460.45, require that industry operators must inform SFPs about mission-related risks, including hazards and risks that could result in serious injury, death, disability, or total or partial loss of physical or mental function, or both. There are many known physiological and medical alterations that occur to healthy individuals in orbital spaceflight, and certain countermeasures are known to be of benefit; however, the full impact of microgravity and other operational stress factors on pre-existing medical conditions is yet to be determined. The SFP medical standards and guidelines in this guide are considered the minimum recommendations, and governmental agencies and operators have the option for additional medical and operational controls.