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GB/T 1962.1-2015 English PDF (GBT1962.1-2015)

GB/T 1962.1-2015 English PDF (GBT1962.1-2015)

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GB/T 1962.1-2015: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirement

GB/T 1962.1-2015
GB
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
GB/T 1962.1-2015 / ISO 594-1.1986
Replacing GB/T 1962.1-2001
Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 1.
General requirement
(ISO 594-1.1986, IDT)
注射器, 注射针及其他医疗器械 6%(鲁尔)圆锥接头
ISSUED ON. DECEMBER 10, 2015
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. General Administration of Quality Supervision, Inspection and Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Dimensions ... 5
4 Requirements ... 7
5 Test methods ... 8
Annex A ... 14
Foreword
GB/T 1962 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment consists of two parts.
- Part 1. General requirement;
- Part 2. Lock fittings.
This Part is the first part of GB/T 1962.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces GB/T 1962.1-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 1. General requirement.
This Part uses translation method and identically adopts ISO 594-1.1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1. General requirements.
The Chinese documents which have consistency with the international
normative reference in this Part are as follows.
GB 15810-2001 Sterile hypodermic syringes for single use (eqv ISO 7886- 1.1993)
YY 0573.3-2005 Sterile hypodermic syringes for single use (ISO 7886-
3.2005, IDT)
YY 0573.4-2010 Sterile hypodermic syringes for single use - Part 4. Syringes with re-use prevention feature (ISO 7886-4.2006, IDT)
This Part makes the following editorial modifications.
- deleted Clause 1 “Introduction” of ISO 594-1.1986.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Part was proposed by State Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on Medical Syringe (Needle) of Standardization Administration of China (SAC/TC 95).
The drafting organization of this Part. Shanghai Institute of Medical
Instrumentation.
Main drafter of this Part. Lu Liyuan.
This Part was issued for the first time in September, 2001.
Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 1.
General requirement
1 Scope
This part of GB/T 1962 specifies requirements for conical fittings with a 6% (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use such as transfusion and infusion sets.
It covers conical fittings made of rigid and of semi-rigid materials and includes test methods for gauging and performance. It excludes provision for more flexible or elastomeric materials.
Figure 1 illustrates typical male 6% (Luer) conical fitting (“male fitting”) and female 6% (Luer) conical fitting (“female fitting”).
NOTE It is not practicable to define the characteristics of rigid or semi-rigid materials with precision, but glass and metal may be considered as typical rigid materials. By contrast, many plastic materials may be regarded as semi-rigid although the wall thickness is an important factor influencing the rigidity of a component.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7886 Sterile hypodermic syringes for single use
3 Dimensions
The dimensions of male and female conical fittings shall be as given in the table and as shown in figure 1.
A typical assembly of 6% (Luer) conical fittings is shown in figure 2.
The dimensions of the assembly shall be as given in the table.

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