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

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.

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.

4 Requirements

There shall be no leakage sufficient to form a falling drop of water under the

test conditions described in 5.2.

The conical fitting under test shall remain attached to the test fixture, under the

test conditions described in 5.4.

There shall be no evidence of stress cracking of the conical fitting, under the

test conditions described in 5.5.

5 Test methods

The procedure shall be carried out as specified in 5.3.1.1 to 5.3.1.7.

Conduct the test as for 5.3.1 but using a syringe with a steel male reference

fitting in accordance with figure 5 to mate with the female fitting under test.

The procedure shall be carried out as specified in 5.5.1 to 5.5.3.

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