Hapool Medical IV Flow reglator controls IV flow stable and accurate during the infusion procedure. Extension set and rate flow regulator iv set with flow regulator available.
– Material
– Colour: green or blue
– Max operating pressure: 0.5 bar in static condition, Gravity Set
– Max sterilization temperature: 50°C
– Operating Range: 10 to 250 mL/h,5 to 200 mL/h
– Tolerance of flow rate: 10%:30~250mL/h is ±20% , 20mL/h is -10% ~ +50% , <20mL/h is not defined
– Stablity of Flow Rate: 10% flow rate fluctuation during 24 hours infusion (tested with NaCl 0,9% solution from glass bottles under room temperature 23±2°C)
– No leakage under 50kpa
– Test height: place the IV solution container at about 100cm above the outlet level
– The inlet and outlet are suitable with Φ2.9*Φ4.05±0.1mm tubing
– Use Cyclohexanone bond with tubing. Please note if cyclohexanone drops enter into the flow regulator body can cause channel clogging
Class: IIa
UMDNS-Code: 16789
Sterilization Way:Can be EO Sterilized
Destination/use:For single use
DEHP Free: Yes
Latex Free: Yes
Biocompatibility: Yes
Non-pyrogenic: Yes
Shelf life: 3 years
Conformity:European Directive 93/42/EEC
Standards:
The applicable harmonized standards:
EN ISO 8536-4:2019 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed
EN ISO14971:2012 Medical devices-Application of risk management to medical devices
EN ISO13485:2016 Medical devices-Quality management systems-Requirements for regulatory purposes
EN ISO 8536-13:2016 Infusion Equipment for medical use- Part 13 Graduated flow regulators for single use with fluid contact
Biocompatibility compliance
ISO10993-5:2009 Report No. T21822019-001
ISO10993-10:2010 Report No. T21822019-002 &T21822019-003
ISO10993-11:2017 Report No. T21822019-004 &T21822019-005
United states Pharmacopeia 42, National Formulary 37 (USP) Report No. T21822019-006
ASTM F756-2017 Report No.: T21822019-007
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