Certifications: CE, RoHS, FCC, FDA, ISO 9001

Which certificates does an X-ray scanner actually need?

It depends on where the machine is installed, not on the manufacturer. A European airport asks for CE marking under the Machinery and EMC directives; a US site asks for FDA listing and FCC compliance; a Chinese site asks for Ministry of Public Security testing. ISO 9001 is not a product certificate at all — it certifies the factory's quality system. Buyers should ask for the certificate and the test report, because a certificate without a report tells you nothing about the model in front of you.

Certificate by market

  • CE — Machinery Directive (MD) (Europe) — Machine safety: guards, interlocks, emergency stop, radiation enclosure
  • CE — Medical Device (MED) (Europe) — Required when the unit is sold for medical or veterinary diagnosis
  • CE — Low Voltage (LVD) (Europe) — Electrical safety of the generator, HV tank and control cabinet
  • RoHS (Europe) — Restricted hazardous substances in the electronics
  • FCC (United States) — Electromagnetic emissions of the control electronics
  • FDA (United States) — Listing/registration of the device for the US market
  • ISO 9001 (Global) — Factory quality management system, audited annually
  • China MPS (China) — Type testing of security screening equipment by the Ministry of Public Security

How to verify a certificate before you buy

Ask for three things: the certificate number with the issuing body, the test report behind it, and the model list on the certificate. Then check the issuing body in the relevant register — an EU notified body has a four-digit number that can be looked up in NANDO, and an ISO certificate must name the certification body and the scope. Certificates that list no model, no standard and no issuing body should be treated as marketing material.

Frequently asked questions

Does a CE certificate cover every model?

No. A CE certificate names the models and standards it covers. If your model is not listed, ask for an amendment or a new test — a certificate for a different tunnel size does not automatically cover yours.

Is FDA the same as 510(k) clearance?

No. Most security X-ray scanners are listed/registered rather than cleared through 510(k), which applies to medical devices with a predicate. Ask which route the manufacturer used and for the corresponding document.

Can I see the original test reports?

Yes — request them with the quotation. A manufacturer that will not share the report for the exact model is telling you something.

Why does ISO 9001 matter if it is not a product certificate?

Because it is the only third-party evidence that the factory has a documented, audited process — which is what you rely on for consistency across repeat orders.