Standard No.:	GB/T 15812.1-2005
Chinese Name:	非血管内导管 第1部分：一般性能试验方法
English Name:	Catheters other than intravascular catheters—Part 1:Test methods for common properties
Professional Classification:	C48 Medical sanitary products
Professional Classification:	GB National Standard
ICS Classification:	11.040.20
Issued by:
Issued on:	2005-03-23
Implemented on:	2005-12-01
Status:	VALID
Replace:	GB/T15812-1995 Flexible polymeric tubes for medical use-Physical perfomence test method
Language:	English
File Format:	PDF
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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