GB/T 15812.1-2005 in English

VALID

Catheters other than intravascular catheters - Part 1 : Test methods for common properties

Issued on:2005-03-23
Implemented on:2005-12-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $80.00
$78.00

Standard No:	GB/T 15812.1-2005
Document status:	VALID
Title in English:	Catheters other than intravascular catheters - Part 1 : Test methods for common properties
Title in Chinese:	非血管内导管第1部分：一般性能试验方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2005-03-23
Implemented on:	2005-12-01
Superseding:	GB/T 15812-1995 Flexible polymeric tubes for medical use-Physical perfomence test method
ICS Classification:	11.040.20-Transfusion, infusion and injection equipment
Chinese Classification:	C48-Medical sanitary products
Professional Classification:	GB-National Standard
Related Keywords:	test methods common properties catheters test method intravascular catheters common properties
Related Topics:	Intravascular intravascular catheter How does blood vessel function GB/T 15812.1 GB/T 15812.1-2005 non-vascular Non-intravascular catheters - Part 1; General performance test methods tube Test method for bending performance of medical non-intravascular catheters Endothelin detection method Test methods for non-intravascular catheter bending performance Intravascular Catheter Sliding Performance Test Hemostatic performance test method Catheter blood culture methods Catheter blood culture collection method

《GB/T 15812.1-2005非血管内导管第1部分:一般性能试验方法》由TC106（全国医用输液器具标准化技术委员会）归口，主管部门为国家药品监督管理局
GB/T 15812的本部分规定了临床使用状态下导管的一般性能试验方法，目的是确保在评价导管性能中的一致性。本部分不适用于血管内导管。

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

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