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GB/T 15812.1-2005 PDF in English


GB/T 15812.1-2005 (GB/T15812.1-2005, GBT 15812.1-2005, GBT15812.1-2005)
Standard IDContents [version]USDSTEP2[PDF] delivered inName of Chinese StandardStatus
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 Valid
GB/T 15812-1995English225 Add to Cart 0-9 seconds. Auto-delivery. Flexible polymeric tubes for medical use--Physical perfomence test method Obsolete
Standards related to (historical): GB/T 15812.1-2005
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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. ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.