Qualitätsnormen

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018

ISO 13485:2016

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Medical Devices for use
with Medical Gases

Included with Notified Confirmation Letter

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TPED/ADR

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ABS CERTIFICATE

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EC CERTIFICATE FOR POC

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REGULATION EC 
No. 1935_2004

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APPENDIX TO
EC CERTIFICATE

TPED EU TYPE-EXAMINATION CERTIFICATES

• TPED 12-466227-00 Shut off Valves for Cylinder Bundles.pdf
• TPED 12-466227-01 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 Pin Index.pdf
• TPED 12-466227-06 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 12-466227-11 Ministar MIV 300, Ministar 2, E-Ministar, MediVitop.pdf
• TPED 12-466227-12 Combi Valves.pdf
• TPED 15-1006198-100 In-line Cylinder Valves with rotating design-GII.pdf
• TPED 15-1006198-101 Off-line Cylinder valves with rotating design-GII.pdf
• TPED 17-1008175-105 Chlorine Cylinder Valve
• TPED 18-1008175-110 Charging valve.pdf
• TPED 19-1008175-114 Valve for small cylinders.pdf
• TPED 20-1008154-118 Diaphragm valve.pdf
• TPED 21-1008175-125 Rev. 0 BV300.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 12-466227-06 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 12-466227-11 Combi valves (Ministar, Ministar 2, E-Ministar, MediVitop).pdf
• Modification list 12-466227-12 Combi valves.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 17-1008175-105 Chlorine cylinder valve
• Modification list 18-1008175-110 Charging valves.pdf
• Modification list 19-1008175-114 Cylinder valve for small cylinders
• Modification list 20-1008175-118 Cylinder valve - Diaphragm valve
• Modification list 21-1008175-125 Shut off valves - BV300

TPED DECLARATION OF CONFORMITY

• DoC TPED_12-466227-01_Rev. 1
• DoC TPED_12-466227-02_Rev. 0
• DoC TPED_12-466227-03_Rev. 0
• DoC TPED_12-466227-04_Rev. 3
• DoC TPED_12-466227-06_Rev. 2
• DoC TPED_12-466227-07 Rev. 0
• DoC TPED_12-466227-09_Rev. 0
• DoC TPED_12-466227-11_Rev. 5
• DoC TPED_12-466227-12_Rev. 3
• DoC TPED_15-1006198-100_Rev. 4
• DoC TPED_15-1006198-101_Rev. 4
• DoC TPED_17-1008175-105_Rev. 0
• DoC TPED_18-1008175-110_Rev. 1
• DoC TPED_19-1008175-114_Rev. 0
• DoC TPED_20-1008175-118_Rev. 1
• DoC TPED_21-1008175-125_Rev. 0

DECLARATION OF CONFORMITY MEDICAL DEVICES

• 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_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_019 - Humidifiers
• 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_15_028 - MARS II
• TF_15_029 - Adjustable Regulators
• TF_21_031 - MediCollect
• TF_21_032 - MediCollect Bag
• REG 00079 Rev. 14 - GCE POC
• TF_21_034 - Terminal Units IIa

CERTIFICATE OF CONFORMITY

• Cylinder Regulators
• Non-return Valves
• Flashback Arrestors
• Cutting and Welding Technologies

DECLARATION OF COMPATIBILITY

• Ambulance Panel System