Catheters other than intravascular catheters -Part 1: Test methods for common properties
1 Scope
This part of GB/T 15812 specifies test methods for common properties for catheters as they relate to the device ready for clinical use. The purpose of this part is to ensure uniformity in the evaluation of catheter properties.
This part is not applicable to intravascular catheters.
2 Test methods and results
The test methods are given in annexes A to F and results shall be expressed as, e.g.:
“Corrosion test according to GB/T 15812.1: No sign of corrosion”.
Unless otherwise specified, tolerances on all variables in the test methods shall be ± 10 %.
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Annex A
(Normative)
Test method for corrosion resistance of metallic components
A.1 Principle
The catheter is immersed in the sodium chloride solution, then in boiling distilled water, and afterwards the metallic components are examined visually for evidence of corrosion.
A.2 Reagents
A.2.1 Saline solution, comprising 9 g/L of analytical reagent grade sodium chloride in freshly prepared, distilled water.
A.2.2 Distilled or deionized water.
A.3 Apparatus
Borosilicate glass beakers.
A.4 Procedure
Foreword i
1 Scope
2 Test methods and results
Annex A (Normative) Test method for corrosion resistance of metallic components
Annex B (Normative) Test method for tensile properties
Annex C (Normative) Test method for resistance to liquid leakage under pressure
Annex D (Normative) Test method for resistance to leakage during aspiration or vacuum
Annex E (Normative) Test method for determining the flow rate of water through the catheter
Annex F (Normative) Test method for security of connectors
