ISO 13485 · CE

Quality system and product standards

Medical gas equipment is life-critical. Tecnomed manufactures under a certified quality management system and designs every product family to the international and national standards that hospital specifications demand.

ISO 13485

Medical device quality management

Design, production, testing and service processes are run under an ISO 13485 quality management system.

EN ISO 7396-1

Medical gas pipeline systems

Source plants, distribution components and terminal units are designed to the European standard for medical gas pipeline systems.

HTM 02-01

UK Health Technical Memorandum

Manifolds, medical air and vacuum plants, alarm systems and AVSUs follow the HTM 02-01 design and safety philosophy widely specified in the Middle East and Africa.

CE – MDD 93/42/EEC

CE marking

Products are CE marked under the Medical Devices Directive.

EN 11197

Medical supply units

Bed head units, ICU units and pendants are manufactured in accordance with EN 11197.

DIN 13260-2 · BS 5682 · AFNOR NF S 90-116

Terminal unit standards

Medical gas outlets, probes and adapters are produced in the three major socket standards so that every project can be matched.

EN 13348

Medical copper pipe

Seamless copper pipe and fittings for medical gases, capped and marked per length.

EN 13458-2 · PED 2014/68/EU

Cryogenic vessels

Liquid oxygen tanks are designed to EN 13458-2 and the Pressure Equipment Directive.

EN 60601-1-2

Electromagnetic compatibility

Alarm and regulator panels comply with the EMC requirements for medical electrical equipment.

Testing before shipment

Every gas outlet is 100% leak tested. Manifolds, regulator panels and alarm units are function tested with the specified gases and pressures. Plants are run and logged before dispatch, and documentation is prepared in English for site commissioning.

Tecnomed

Planning a hospital medical gas project?

Send us your drawings or bill of quantities. Our engineers reply with a technical proposal, usually within the same week.