Compliance, standard by standard

Hipertech designs, builds, and documents chambers against medical-device, pressure-equipment, and dive-safety standards. Not every standard applies to every chamber.

Medical device conformity
Standard	What it covers
CE Mark	EU conformity marking for medical devices
MDR EU 2017/745	EU Medical Device Regulation (current)
93/42/EEC	EU Medical Devices Directive. Superseded by MDR, still cited in long-form documents
EN ISO 13485:2016	Medical device quality management systems
EN 14931	Pressure vessels for human occupancy, medical use

Pressure equipment
Standard	What it covers
ASME PVHO	Pressure vessels for human occupancy
ASME Section VIII	Pressure vessel design code
PED 2014/68/EU	EU Pressure Equipment Directive (current)
97/23/EC	EU pressure equipment directive. Superseded by PED 2014/68/EU
EN 13445	Unfired pressure vessels

Fire, gas and breathing safety
Standard	What it covers
EN 16081	Fire suppression in hyperbaric chambers
NFPA 99	Health Care Facilities Code (US), hyperbaric facilities
EN 12021	Breathing air specifications

Management systems
Standard	What it covers
ISO 9001	Quality management
ISO 14001	Environmental management
OHSAS 18001	Occupational health and safety

Legacy directives are listed because they still appear in long-form documentation and older tenders. The applicable set for a given chamber is listed on that chamber’s product page.

The bodies behind the marks

Hipertech’s certification and classification documentation references TÜV SÜD, TÜV Austria, Bureau Veritas and DNV. The marks below are the ones Hipertech is entitled to display.

Hipertech is an official IMCA Supplier (S) Member, which supports the diving chamber product line.

Marks and membership

Certification and classification bodies

Which standards apply depends on the chamber, the market and the buyer’s regulator.

Medical chambers carry the medical-device set. Diving chambers carry the pressure-equipment set and IMCA membership. Each product page lists the standards that apply to that chamber.

Certificate copies on request

Copies are not published on this site; name the chamber you are specifying and the request goes to the engineer who holds its documentation.

Request documentation