Quality Standards

ISO 9001:2015

ISO 13485:2016

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Medical Devices for use
with Medical Gases

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EC CERTIFICATE

(for the Italian market)

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TPED/ADR

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STATEMENT OF AUDIT
PERFORMANCE

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TPED PRODUCTION CERTIFICATES

• TPED 12-466227-00 Rev 2 Shut off Valves for Cylinder Bundles.pdf
• TPED 12-466227-01 Rev 1 Cylinder Valves with rotating design.pdf
• TPED 12-466227-02 Cylinder valves with non-rotating design.pdf
• TPED 12-466227-03 IVC.pdf
• TPED 12-466227-04 Rev 2 Pin Index.pdf
• TPED 12-466227-05 Wing valve.pdf
• TPED 12-466227-06 Rev 1 SMV.pdf
• TPED 12-466227-07 Cylinder valve for Oxygen 300 bar.pdf
• TPED 12-466227-08 Combilite Argon.pdf
• TPED 12-466227-09 Combihelium Plus.pdf
• TPED 12-466227-10 Mini IVC.pdf
• TPED 12-466227-11 Rev 5 Ministar MIV 300, Ministar 2, E-Ministar, MediVitop.pdf
• TPED 12-466227-12 Rev 3 Combi Valves.pdf
• TPED 15-1006198-100 Rev 2 In-line Cylinder Valves with rotating design-GII.pdf
• TPED 15-1006198-101 Rev 3 Off-line Cylinder valves with rotating design-GII.pdf
• TPED 17-1008175-105 Chlorine Cylinder Valve
• TPED 18-1008175-110 Rev 1 Charging valve.pdf
• TPED 19-1008175-114 Valve for small cylinders.pdf

TPED MODIFICATION LISTS

• Modification list 12-466227-00 Shut off Valves.pdf
• Modification list 12-466227-01 Cylinder Valves with rotating design.pdf
• Modification list 12-466227-02 Cylinder valves with non-rotating design.pdf
• Modification list 12-466227-03 IVC.pdf
• Modification list 12-466227-04 Pin Index.pdf
• Modification list 12-466227-05 Wing valve.pdf
• Modification list 12-466227-06 SMV.pdf
• Modification list 12-466227-07 Cylinder valve for Oxygen 300 bar.pdf
• Modification list 12-466227-08 Combilite Argon.pdf
• Modification list 12-466227-09 Combihelium Plus.pdf
• Modification list 12-466227-10 Mini IVC.pdf
• Modification list 12-466227-11 Combi valves (Ministar, Ministar 2, E-Ministar, MediVitop).pdf
• Modification list 12-466227-12 Medivital Combivalves.pdf
• Modification list 15-1006198-100 In-line Cylinder Valves with rotating design-GII.pdf
• Modification list 15-1006198-101 Off-line Cylinder valves with rotating design-GII.pdf
• Modification list 18-1008175-110 Charging valves.pdf

DECLARATION OF CONFORMITY

• TF_01_004 - Cylinder Valves
• TF_02_005 - Pressure regulators integrated with cylinder valves
• TF_03_006 - High pressure regulators
• TF_04_007 - Suction equipment
• TF_05_009 - Low pressure regulators
• TF_06_010 - Gas switch
• TF_06_011 - Terminal unit
• TF_06_012 - Low pressure hoses
• TF_06_014 - Flow-metering device
• TF_06_015 - Central gas supply system
• TF_08_017 - Demand valve
• TF_08_018 - Resuscitator
• TF_08_019 - Humidifiers
• TF_10_022 - Central gas supply system - Gas alarm
• TF_10_023 - Central gas supply system - Shut off valve systems
• TF_10_024 - Central gas supply system - Pressure monitor
• TF_10_025 - Gas saver
• TF_12_026 - Ambulance Panel II
• TF_14_027 - Ambulance Panel System
• TF_15_028 - MARS II
• TF_15_029 - Varimed+

CERTIFICATE OF CONFORMITY

• Cylinder Regulators