GB/T 15812.1-2005Catheters other than intravascular catheters -- Part 1: Test methods for common for properties (English PDF)

Foreword

This Part of GB/T 15812 identically uses EN 1618.1997 Catheters other than

intravascular catheters - Test methods for common properties.

The title for GB/T 15812 is Catheters other than intravascular catheters. It

consists of the following parts.

- Part 1. Test methods for common properties;

- Part 2. Flexible polymeric tubes for medical use - Physical performance

test method.

This Part replaces the test methods other than the method for bending

resistance test in GB/T 15812-1995. The test items and methods specified in

this Part are greatly different from GB/T 15812-1995 so it is basically not

comparable.

Annex A, Annex B, Annex C, Annex D, Annex E and Annex F are normative.

This Part was proposed by State Drug Administration.

This Part shall be under the jurisdiction of National Technical Committee on

Medical Infusion Equipment of Standardization Administration of China.

Main drafting organization of this Part. Shandong Medical Equipment Product

Quality Inspection Center, Jinan Medical Silicone Rubber Products Factory.

Main drafters of this Part. Wu Ping, Zhang Qiang, Song Jinjie, Chen Jun.

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

the standard 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 F

(Normative)

Test method for security of connectors

F.1 Test for separation

The connector(s) are assembled in accordance with the manufacturer's

instructions. A tensile force is applied and the assembled connection

inspected for separation.

F.2 Apparatus

Tensile testing apparatus, capable of exerting a force of greater than 15 N.

F.3 Procedure

Assemble the connectors in accordance with the manufacturer's instructions.

Fix the assembled connectors in the tensile test apparatus (using an

appropriate fixture to avoid deforming the connector, if necessary).

Apply a tensile force, as specified in the product standard, at a testing speed

of 500 mm/min, Inspect the assembled connectors for separation.

F.4 Test report

The test report shall include the following information.

a) identity of the catheter;

b) identity of the connector(s);

c) force applied, in newtons and whether the connectors separated.

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