Key takeaways
- CE: meets EU electrical safety and EMC directives.
- FCC: meets US electromagnetic emissions limits.
- RoHS: restricted hazardous substances in components.
- ISO 9001: quality management system for the factory.
- ISO 13485: medical-device quality management system for the factory — not a medical-device approval.
Hardware certifications
CE and FCC apply to the finished device. They test for electrical safety and electromagnetic compatibility. RoHS is a materials declaration: solder, plastics and printed circuit boards comply with EU restricted-substance limits.
Factory certifications
ISO 9001 and ISO 13485 are management-system standards. They certify how the factory runs — documentation, traceability, complaint handling — not the device itself.
What none of these mean
None of these certifications make a hydrogen machine a medical device. They describe hardware and manufacturing quality, not therapeutic status.
Frequently asked questions
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Source content adapted from certifications.