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YY/T 0296-2013

Chinese Standard: 'YY/T 0296-2013'
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YY/T 0296-2013English170 Add to Cart 0--15 minutes. Auto immediate delivery. Hypodermic needles for single use. Colour coding for identification Valid YY/T 0296-2013
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Detail Information of YY/T 0296-2013; YY/T0296-2013
Description (Translated English): Hypodermic needles for single use. Colour coding for identification
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.25
Word Count Estimation: 11,119
Older Standard (superseded by this standard): YY/T 0296-1997
Adopted Standard: ISO 6009-1992, IDT
Drafting Organization: Shanghai Medical Device Testing
Administrative Organization: National medical syringe (needle) Standardization Technical Committee
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization: State Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the nominal diameter from 0. 3mm ~ 3. 4mm single-use needles with color-coded identification. This standard applies to the normal wall, thin-walled and thin-walled needle and opaque colors and translucent colors.

YY/T 0296-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.25
C 31
YY/T 0296-2013 / ISO 6009.1992
Replacing YY/T 0296-1997
Hypodermic needles for single
use - Color coding for identification
一次性使用注射针 识别色标
(ISO 6009.1992, IDT)
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Color code ... 5
Annex A (informative) Reference color samples ... 7
Annex B (informative) Color zones for opaque colors ... 8
Annex C (informative) Color samples for opaque colors ... 12
Bibliography ... 13
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY/T 0296-1997 “Hypodermic needles for single use - Color
coding for identification”. Main technical differences between this Standard and YY/T
0296-1997 are as follows.
- MODIFY the contact information of the organization that provides reference color
samples;
- MAKE editorial modifications to the standard text.
This Standard is identical to ISO 6009.1992 “Hypodermic needles for single use - Color
coding for identification” and its amendment 1.2008.
This Standard has been made editorial modifications to the format of the text of ISO
6009.1992, and modified the contact information of the organization that provides
reference color samples.
Attention is drawn to the possibility that some of the elements of this Standard may be
the subject of patent rights. Issuing organizations of this Standard shall not be held
responsible for identifying any or all such patent rights.
This Standard is proposed by State Food and Drug Administration.
This Standard is under the jurisdiction of National Technical Committee on Medical
Hypodermic Syringes (Needles) of Standardization Administration of China (SAC/TC
95).
Drafting organization of this Standard. Shanghai Medical Devices Testing Institute.
Main drafter of this Standard. Hua Songhe.
This Standard was first published in 1997.
Introduction
The intention of this Standard is to specify colors to enable rapid visual identification
of the outside diameter of single-use hypodermic needles (hereinafter referred to as
hypodermic needles). The presence of color coding on a needle or package does not
absolve the user of the responsibility to check the marked size of the needle.
The colors used to code needles may be applied in either opaque or transparent form,
and the color code is equally applicable to normal-walled, thin-walled and extra-thin-
walled needles. The nominal outside diameters of needles listed in this Standard for
which colors are given are those specified in GB 15811. This does not imply that
hypodermic needles of all the listed nominal outside diameters are currently
manufactured.
This Standard establishes a color code but does not specify that needles are to be
color-coded or to what portion of the needle and/or packaging the color is to be applied.
Such requirements may be given in the relevant product standards such as GB 18457.
The Technical Committee responsible for the preparation of this Standard has
reviewed the use of instrumentally determined color zones (chromaticity and
luminance index) as used in previous editions to specify opaque colors, and has
decided that instrumental measurement is not practicable. The measurement of the
color zone of an opaque color, especially of an item of the size and shape of the hub
of a needle, is a complex procedure requiring apparatus and expertise that is to be
found in relatively few laboratories and test houses. It may therefore be inconvenient,
difficult or impossible for a manufacturer or purchaser routinely to assess compliance
of a product with color zone values. Such difficulties are compounded in the case of
translucent colors, which are being used increasingly by needle manufacturers to allow
air bubbles inside the hub to be seen and eliminated before injection.
As a consequence, the colors in this Standard are specified by name, accepting that
this inevitably introduces a certain amount of subjectivity in the assessment of
compliance. This subjectivity may be minimized by viewing the hubs under controlled
lighting conditions (e.g. “daylight” (D65) illumination at 1 000 lx to 1 500 lx) and by the
use of assessors of medically-demonstrated correct color vision. Visual comparison of
the color of a product with a reference color sample Is simple and quick, and is
therefore a useful routine method of product assessment. Accordingly, reference color
samples have been made available. These take the form of sets of needle hubs of
colors complying with this Standard. Details are given in annex B and it should be
noted that only those diameters of needle currently having colored hubs are included
(i.e. 0.3 mm to 1.2 mm nominal outside diameter). It is expected that the range of
diameters included in the reference color samples will be extended in due course.
Annex A
(informative)
Reference color samples
The reference color samples referred to in this Standard are available by contacting.
Melab
Medizintechnik und Labor GmbH
Mollenbachstrasse 19
712299 Leonberg
Germany
info@melab.de
This information is given for the convenience of the users of this Standard and does
not constitute an endorsement of the reference color......
Related standard:   YY 0286.1-2019  YY 0286.3-2017
   
 
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