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一次性使用注射针 识别色标
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标准编号: YY/T 0296-2013 (YY/T0296-2013)
中文名称: 一次性使用注射针 识别色标
英文名称: Hypodermic needles for single use. Colour coding for identification
行业: 医药行业标准 (推荐)
中标分类: C31
国际标准分类: 11.040.25
字数估计: 11,133
旧标准 (被替代): YY/T 0296-1997
采用标准: ISO 6009-1992, IDT
起草单位: 上海市医疗器械检测所
归口单位: 全国医用注射器(针)标准化技术委员会
标准依据: 国家食品药品监督管理总局公告2013年第36号;行业标准备案公告2013年第12号(总第168号)
提出机构: 国家食品药品监督管理总局
发布机构: 国家食品药品监督管理总局
范围: 本标准规定了公称外径从0.3mm～3.4mm的一次性使用注射针识别用色标。本标准适用于正常壁、薄壁和超薄壁的针以及不透明颜色和半透明颜色。
YY/T 0296-2013
Hypodermic needles for single use.Colour coding for identification
ICS 11.040.25
C31
中华人民共和国医药行业标准
代替YY/T 0296-1997
一次性使用注射针 识别色标
(ISO 6009:1992,IDT)
2013-10-21发布
2014-10-01实施
国家食品药品监督管理总局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
本标准代替YY/T 0296-1997《一次性使用注射针 识别色标》,与YY/T 0296-1997的主要技
术差异如下:
---修改了提供对照色样单位的联系方式;
---对标准正文进行了编辑性修改。
本标准等同采用ISO 6009:1992《一次性使用注射针 识别色标》及其修改件1:2008。
本标准对ISO 6009:1992标准正文的编写格式进行了编辑性修改并修改了提供对照色样单位的联
系方式。
请注意本标准的某些内容可能涉及专利。本标准的发布机构不承担识别这些专利的责任。
本标准由国家食品药品监督管理总局提出。
本标准由全国医用注射器(针)标准化技术委员会(SAC/TC95)归口。
本标准起草单位:上海市医疗器械检测所。
本标准主要起草人:花松鹤。
本标准首次发布于1997年。
引 言
本标准旨在对一次性使用注射针(以下简称注射针)的公称外径规定颜色,以便目力快速识别。即
使注射针或包装上有色码,使用者仍有责任查证注射针的标示规格。
用作注射针色标的颜色,可以是不透明状,也可以是透明状,并且该色标同等适用于正常壁、薄壁和
超薄壁的针。本标准中列出并为之给定的注射针公称外径是GB 15811中规定的针管公称外径。但这
不意味着所有列出公称外径的注射针目前都有生产。
本标准只规定了色标,但没有规定注射针应有色标,也没有规定颜色应标在注射针和/或包装的哪
一部分。这样的要求可以在相关的产品标准如GB 18457中规定。
负责制定本标准的技术委员会审视了以前各版本中在规定不透明颜色时采用以仪器测定的色区问
题(色度和亮度指数)并且确认以仪器测量是不实际的。测量不透明颜色的色区,特别是针座那样大小
和形状的物体的不透明颜色的色区,是一个复杂的过程;所需的仪器和专业知识只是在较少数实验室和
试验室才具备。因此对生产方和购买方来说,日常评定一个产品是否符合色区值那是不方便的、困难
的、甚至是不可能的,对半透明颜色来说,这样的困难更突出了,而注射针生产厂正日益增多地采用半透
明颜色以便能看见针座内的气泡并在注射前把它排除。
因此,本标准中的颜色是以名字来规定的,同时承认在符合性评定时不可避免地引入了一些主观成
分。如果在有控制的光照条件下(例如照度在1000lx~1500lx的“日光”D65下)检查针座并使用经
医学证明具有正确颜色视力的评估员,这种主观性可减至最小程度,将产品的颜色与对照色样进行目力
比较,既简单又快速,所以对产品的评价是一个实用的常规方法。而且,对照色样已经有供应。这些对
照色样被做成颜色符合本标准的整套针座的形式。详见附录B并且应当指出的是对照色样只包括了
目前有颜色针座的注射针的直径(即0.3mm~1.2mm公称外径),希望对照色样内包含的直径范围将
适时扩大。
一次性使用注射针 识别色标
1 范围
本标准规定了公称外径从0.3mm~3.4mm的一次性使用注射针识别用色标。
本标准适用于正常壁、薄壁和超薄壁的针以及不透明颜色和半透明颜色。
2 色标
表1给出的颜色表示针管公称外径。
表1
针的公称外径
mm
颜色
0.3 黄
0.33 红
0.36 蓝-绿
0.4 中灰
0.45 褐
0.5 橙
0.55 中紫
0.6 深蓝
0.7 黑
0.8 深绿
0.9 黄
1.1 奶油色
1.2 粉红
1.4 红-紫
1.6 白
1.8 蓝-灰
2.1 淡绿
2.4 紫
2.7 浅蓝
3 绿-蓝
3.4 橄榄褐
注1:注意选择可取作对照色样的对照针座套(见附录A)。
注2:附录B和附录C分别给出了不透明颜色的色区和某些色谱图中最接近的色样,供参考。
(资料性附录)
对照色样
本标准中提及的对照色样可与下述单位联系获得:
Melab
MedizintechnikundlaborGmbH
Molenbachstrasse19
71229Leonberg
Germany
info@melab.de
附 录 B
(资料性附录)
不透明颜色的色区
B.1 在下列条件下,使用分光光度计以等距离波长法(Δλ=10nm)测量色度(x,y)和亮度指
数r(β=10-2r):
a) 照明和测定条件:按照国际照明委员会(CIE)No.15.2出版物,光谱耀眼光除外;
b) 比色观测对照物:按照CIE出版物No.15.2,2°;
c) 发光物:按照CIE出版物No.15.2,C光源;
d) 对照白:硫酸钡板所近似的完全反射漫射面。
表B.1 不透明颜色的颜色区
针的公称外径
mm
颜 色 色 区
0.3 黄
x=0.448 x=0.507
y=0.468 y=0.492
β>0.40
x=0.488 x=0.468
0.33 红
x=0.540 x=0.560
y=0.326 y=0.280
0.10<β<0.20
x=0.500 x=0.610
y=0.289 y=0.330
0.36 蓝-绿
x=0.203 x=0.267
y=0.300 y=0.347
x=0.246 x=0.234
y=0.306 y=0.370
0.4 中灰
x=0.302 x=0.323
y=0.314 y=0.315
0.20<β<0.50
x=0.313 x=0.303
y=0.324 y=0.302
0.45 褐
y=0.332 y=0.338
0.04<β<0.15
x=0.440 x=0.367
y=0.356 y=0.325
表B.1(续)
针的公称外径
mm
颜 色 色 区
0.5 橙
y=0.394 y=0.394
0.22<β<0.40
x=0.542 x=0.498
y=0.421 y=0.375
0.55 中紫
x=0.258 x=0.294
y=0.193 y=0.243
0.07<β<0.20
x=0.274 x=0.285
0.6 深蓝
x=0.151 x=0.203
y=0.178 y=0.182
0.05<β<0.10
x=0.197 x=0.164
y=0.218 y=0.132
0.7 黑
x=0.198 x=0.350
y=0.313 y=0.319
x=0.315 x=0.290
y=0.338 y=0.273
0.8 深绿
x=0.013 x=0.310
y=0.745 y=0.441
0.09<β<0.20
x=0.310 x=0.254
y=0.685 y=0.397
0.9 黄
y=0.468 y=0.492
β>0.40
x=0.448 x=0.468
y=0.511 y=0.456
1.1 奶油
x=0.331 x=0.377
y=0.341 y=0.364
0.65<β<0.80
x=0.356 x=0.341
1.2 粉红
x=0.328 x=0.407
y=0.308 y=0.338
0.40<β<0.60
x=0.332 x=0.373
y=0.321 y=0.282
表B.1(续)
针的公称外径
mm
1.4 红-紫
x=0.300 x=0.320
y=0.287 y=0.270
0.40<β<0.65
x=0.288 x=0.316
y=0.254 y=0.293
1.6 白
x=0.297 x=0.330
y=0.308 y=0.318
x=0.310 x=0.303
y=0.326 y=0.295
1.8 蓝-灰
x=0.250 x=0.295
y=0.267 y=0.314
0.10<β<0.20
x=0.262 x=0.290
y=0.309 y=0.299
2.1 淡绿
y=0.367 y=0.369
0.45<β<0.65
x=0.337 x=0.307
y=0.376 y=0.336
2.4 紫
x=0.329 x=0.411
y=0.233 y=0.241
0.10<β<0.20
x=0.338 x=0.376
2.7 淡蓝
x=0.197 x=0.291
y=0.197 y=0.306
0.20<β<0.65
x=0.200 x=0.289
y=0.260 y=0.294
3 绿-黄
x=0.350 x=0.380
y=0.525 y=0.450
x=0.336 x=0.420
y=0.450 y=0.525
3.4 橄榄褐
x=0.402 x=0.392
y=0.443 y=0.372
0.10<β<0.25
x=0.362 x=0.454
y=0.386 y=0.415
附 录 C
不透明颜色的色样
表C.1给出了与本标准所规定的颜色最接近的色样。
表C.1
针的公称外径
mm
颜色样品
蒙赛尔色图 美国联邦标准595a 德国标准DAL840HR 法国标准NFX08-002
0.3 3.75Y8/14 23.655 1.021 1.330
0.33 - - - -
0.4 N7 26.231 7.035 3.630
0.45 10R4/4 10075 8017 2020
0.5 3.75YR6/12 12473 2003 1130
0.55 2.5P4/8 27144 4005 2710
0.6 2.5PB3/8 15090 5010 1540
0.7 N2.0 27038 9005 2603
0.8 2.5G4/8 14090 6001 2455
0.9 3.75Y8/14 23655 1021 1330
1.1 10YR9/2 27769 1015 2225
1.6 N9.5 27875 9010 2665
1.8 5.0B4/2 35189 7031 3520
2.1 10GY8/2 24504 6019 3470
2.4 - - - -
2.7 2.5PB7/8 35190 5012 2590
3 - - - -
3.3 - - - -
参 考 文 献
[1] ISO 7864:1988,Sterilehypodermicneedlesforsingleuse.
[3] CIEPublicationNo.15.2:1986,Colorimetry.
[4] MunselBookofColor.
[5] USAFederalStandard595a,Colors-Vol.1.
[6] GermanStandardRAL840.HRFarbregister(Colourreglster).
[7] FrenchStandardNFX08-002.Collectionreduitedescouleurs-Designationetcataloguedes
couleursCCR-Etaionssecondaires(Limiledcollectlonofcolours-Designationandcata-logueofCCR
colours-SecondaryStandards).
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
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
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
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 samples.
Bibliography
[1] ISO 7864.1988, Sterile hypodermic needles for single use.
[2] ISO 9628.1991, Stainless steel needle tubing for the manufacture of medical
devices.
[4] Munsell Book of Color.
[5] USA Federal Standard 595a, Colors-Vol.1.
[6] German Standard RAL 840, HR Farbregister (Color register).
[7] French Standard NFX 08-002, Collection reduite des couleurs - Designation et
catalogue des couteurs CCR - Etaions secondaires (Limited collection of colors -
Designation and catalogue of CCR colors - Secondary Standards).
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