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GB/T 15812.1-2005 (GB/T15812.1-2005)

Chinese standards (related to): 'GB/T 15812.1-2005'
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GB/T 15812.1-2005English85 Add to Cart 0-9 seconds. Auto delivery. Catheters other than intravascular catheters -- Part 1: Test methods for common for properties GB/T 15812.1-2005 Valid GBT 15812.1-2005
GB/T 15812-1995English225 Add to Cart 0-9 seconds. Auto delivery. Flexible polymeric tubes for medical use--Physical perfomence test method GB/T 15812-1995 Obsolete GBT 15812-1995



GB/T 15812.1-2005: PDF in English (GBT 15812.1-2005)
GB/T 15812.1-2005
GB
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 48
Replacing GB/T 15812-1995
Catheters other than intravascular catheters –
Part 1. Test methods for common properties
(EN 1618.1997, IDT)
ISSUED ON. MARCH 23, 2005
IMPLEMENTED ON. DECEMBER 1, 2015
Issued by. General Administration of Quality Supervision, Inspection
and Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Test methods and results... 4 
Annex A (Normative) Typical product structure ... 5 
Annex B (Normative) Test method for tensile properties ... 6 
Annex C (Normative) Test method for resistance to liquid leakage under
pressure ... 8 
Annex D (Normative) Test method for resistance to leakage during aspiration
or vacuum ... 9 
Annex E (Normative) Test method for determining the flow rate of water
through the catheter ... 11 
Annex F (Normative) Test method for security of connectors ... 13 
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.
......

BASIC DATA
Standard ID GB/T 15812.1-2005 (GB/T15812.1-2005)
Description (Translated English) Catheters other than intravascular catheters. Part 1: Test methods for common for properties
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C48
Classification of International Standard 11.040.20
Word Count Estimation 11,193
Date of Issue 2005-03-23
Date of Implementation 2005-12-01
Older Standard (superseded by this standard) GB/T 15812-1995
Adopted Standard EN 1618-1997; IDT
Drafting Organization Shandong Medical Devices Product Quality Inspection Center
Administrative Organization National Standardization Technical Committee medical infusion
Regulation (derived from) Announcement of Newly Approved National Standards No. 6, 2005 (No. 80 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee
Summary This standard specifies: catheter under clinical status general performance test methods, purpose is to ensure that the performance evaluation of the catheter in consistency. This standard does not apply to intravascular catheters.