X-Ray Screening Regulations & Standards

X-ray screening is governed by two largely separate sets of rules. Radiation-safety rules control how much radiation a machine may emit and how it must be installed and operated. Security rules decide what must be screened, with which approved equipment, and to what detection standard. Knowing which regulator covers which question saves a lot of confusion.

United States: radiation safety

FDA / CDRH — the manufacturer's standard

Under the Federal Food, Drug, and Cosmetic Act (the electronic product radiation control provisions, originally the Radiation Control for Health and Safety Act of 1968), the FDA regulates radiation-emitting electronic products. Baggage, parcel and industrial cabinet X-ray systems must meet 21 CFR 1020.40, which among other things:

• limits radiation emitted from the cabinet to 0.5 milliroentgen in one hour at any point 5 cm from the external surface;
• requires safety interlocks on doors and access panels, a key-operated control, and indicators showing when X-rays are being generated;
• requires warning labels and user instructions.

Manufacturers must also certify compliance and submit product reports under 21 CFR Parts 1002 and 1010. FDA's limit is on leakage from the machine — it is not a limit on the dose to items inside the tunnel.

States — the user's registration

In most states, owners of X-ray equipment must register it with the state radiation control program and follow state rules on surveys, operator training and records. Radioactive sources (for example in some cargo scanners or industrial radiography) are licensed by the NRC or by Agreement States; industrial radiography with sealed sources falls under 10 CFR Part 34.

Personnel screening and workers

X-ray systems that scan people for security are covered by the consensus standard ANSI/HPS N43.17, which limits the effective dose per screening to 0.25 µSv. Occupational exposure is limited by NRC (10 CFR Part 20) or state rules, and OSHA's 29 CFR 1910.1096 for workplaces outside those programmes.

United States: security requirements

• TSA was created by the Aviation and Transportation Security Act of 2001 and regulates civil aviation security under 49 CFR Chapter XII: Part 1540 (general), 1542 (airports), 1544 (aircraft operators), 1546 (foreign air carriers), 1548 (indirect air carriers) and 1549 (certified cargo screening).
• Detailed screening procedures and Security Directives / Emergency Amendments are Sensitive Security Information and are not published.
• For checkpoint and checked baggage, TSA tests, qualifies or certifies equipment itself (explosives detection systems are certified through the Transportation Security Laboratory) and buys the machines it operates. A private company cannot simply buy a scanner and declare it “TSA-approved”.
• For air cargo, TSA publishes the Air Cargo Screening Technology List (ACSTL) of equipment that regulated parties may use. See air cargo screening.
• The DHS SAFETY Act (designation and certification of Qualified Anti-Terrorism Technologies) provides liability protection to sellers of anti-terrorism technology; it is not an equipment approval for screening.

European Union

• Regulation (EC) No 300/2008 sets common rules for civil aviation security; Commission Implementing Regulation (EU) 2015/1998 contains the detailed measures for passengers, cabin and hold baggage, cargo, mail, staff and equipment. Some details are in a non-public Commission decision.
• Hold baggage: 100% screening of hold baggage has been required in the EU since the early 2000s. EU rules then required explosive detection systems meeting Standard 3, phased in over several years with extended deadlines at some airports. See checked baggage EDS.
• Cargo: all cargo must be screened or come from a secure supply chain (regulated agents, known consignors); carriers flying into the EU from third countries need ACC3 designation.
• Equipment approval: security equipment is evaluated through the ECAC Common Evaluation Process (CEP); equipment that meets EU standards can carry the “EU Stamp” and is then accepted throughout the EU.
• Radiation: Council Directive 2013/59/Euratom (Basic Safety Standards) covers occupational and public exposure and has specific provisions for “non-medical imaging exposure”, including security screening of people with ionising radiation, which member states must justify and control.

International

• ICAO Annex 17 sets the international standards for aviation security; ICAO's Aviation Security Manual (Doc 8973) gives restricted guidance on implementation.
• IAEA General Safety Requirements Part 3 (the international Basic Safety Standards) and related guides cover radiation protection for cargo scanners, industrial radiography and other sources.
• World Customs Organization SAFE Framework of Standards guides customs risk management and the use of non-intrusive inspection equipment.
• National aviation security regulators (for example the UK Department for Transport/CAA or India's Bureau of Civil Aviation Security) implement Annex 17 locally and approve equipment and training.

Practical compliance checklist for equipment owners

• Confirm the equipment has the correct manufacturer certification (in the US, compliance with 21 CFR 1020.40 and the certification label).
• Register the equipment with the radiation regulator and appoint a responsible person or radiation safety officer.
• Carry out an acceptance radiation survey and periodic surveys, and after any relocation or repair — see shielding and surveys.
• Keep interlocks, warning lights and labels functional; never bypass interlocks.
• Train operators in both radiation safety and image interpretation — see training.
• If the screening is mandated by an aviation or cargo security programme, use equipment from the relevant approved list and follow the programme's procedures.

Frequently asked questions

In the USA, baggage inspection X-ray devices are designed and manufactured to regulatory standards issued by which agency?

The Food and Drug Administration (FDA), through its Center for Devices and Radiological Health. The applicable performance standard is 21 CFR 1020.40 for cabinet X-ray systems.

What does 21 CFR 1020.40 limit?

It limits radiation emitted from a cabinet X-ray system to 0.5 milliroentgen in one hour at 5 cm from any external surface, and requires interlocks, controls, indicators and warning labels.

What are TSA's requirements for an X-ray machine?

TSA sets detection and operational requirements through its own testing, qualification and certification, and procures checkpoint and checked baggage equipment itself. For air cargo, regulated parties must use equipment on TSA's Air Cargo Screening Technology List.

Does EU legislation require 100% screening?

Yes for hold baggage and passengers, and for air cargo everything must be either screened or come from a secure supply chain under Regulation (EC) 300/2008 and Implementing Regulation (EU) 2015/1998.

Sources

• eCFR — 21 CFR 1020.40, Cabinet X-ray systems
• FDA — Cabinet X-ray systems (security, industrial)
• eCFR — 49 CFR Chapter XII (TSA)
• TSA — Cargo programs
• EUR-Lex — Regulation (EC) No 300/2008
• EUR-Lex — Implementing Regulation (EU) 2015/1998
• ECAC — Common Evaluation Process
• EUR-Lex — Council Directive 2013/59/Euratom
• ICAO — Aviation security

Last reviewed on 2026-10-04.