What Certifications Should You Ac...
What Certifications Should You Actually Check Before Buying a Hyperbaric Chamber?
The Biohackn Show by Emma Carter
S1 · E28
Aug 28, 2026
06:18
Episode notes

Most buyers scroll straight past the certification logos on a chamber brochure and assume someone already checked it all. This episode explains why that assumption is risky — and what those logos actually mean once you look closer.

You'll learn why "ISO certified" isn't enough on its own — ISO 13485 covers a manufacturer's quality management system, not automatic approval of every product for every market. You'll hear about ASME PVHO-1 (Pressure Vessels for Human Occupancy), the standard specifically relevant to hard shell chambers, and why a logo pasted into a PDF isn't proof the actual pressure vessel was designed and tested to it. You'll learn that "CE" can apply to a single component (like an oxygen concentrator) rather than the complete chamber system, and that "FDA registered" is not the same claim as "FDA approved." You'll also hear  ... 

Keywords
biohackn
hyperbaric chamber certifications
ISO 13485 medical device
ASME PVHO-1 pressure vessel
CE marking hyperbaric chamber
FDA registered vs FDA approved
HBOT regulatory compliance
What place this episode is about
Where this episode is made