Intravascular catheters ISO 10555-1, -3, -4, -5
Normative References
ISO 10555-1: Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
ISO 10555-3: Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
ISO 10555-4: Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
ISO 10555-5: Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters
ISO 11070: Sterile single-use intravascular catheter introducers
DIN EN 12006-3: Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Blutgefäßstents und Hohlvenenfilter
ASTM F2528: Standard Test Methods for Enteral Feeding Devices with Retention Balloon
EndoLab®GmbH performs different tests on intravascular catheters, e.g.:
- Test for corrosion resistance
- Determination of peak tensile force
- Test method for liquid leakage under pressure
- Test for balloon rated burst pressure (RBP)
- Test for balloon deflation time
- Test for balloon diameter to inflation pressure
- Determination of strength of union of needle hub and needle tube
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