Standard No.:	GB/T 15812.1-2005
English Name:	Catheters other than intravascular catheters - Part 1 : Test methods for common properties
Chinese Name:	非血管内导管 第1部分：一般性能试验方法
Chinese Classification:	C48    Medical sanitary products
Professional Classification:	GB    National Standard
ICS Classification:	11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Source Content Issued by:	AQSIQ;SAC
Issued on:	2005-3-23
Implemented on:	2005-12-1
Status:	valid
Superseding:	GB/T 15812-1995 Flexible polymeric tubes for medical use-Physical perfomence test method
Target Language:	English
File Format:	PDF
Word Count:	3000 words
Translation Price(USD):	80.0
Delivery:	via email in 1 business day

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 %.   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