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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
Hypodermic needles for single use.Colour coding for identification
ICS 11.040.25
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0296-1997
One-time use of injection needle to identify the color
(ISO 6009..1992, IDT)
2013-10-21 release
2014-10-01 implementation
State Food and Drug Administration issued
Preface
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0296-1997 "One-time use of injection needle identification color standard", and YY/T 0296-1997 the main skills
The difference is as follows.
--- to modify the way to provide control color units of contact;
--- Editorial changes to the standard text.
This standard is equivalent to ISO 6009..1992 "One - time use of injection needle identification color standard" and its amendment 1..2008.
This standard edits the revision of the ISO 6009..1992 standard text and modifies the format of the collation units
Way system.
Please note that some of the contents of this standard may involve patents. The issuer of this standard does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is the national medical syringe (needle) Standardization Technical Committee (SAC/TC95) centralized.
The drafting of this standard. Shanghai Medical Devices Testing Institute.
The main drafters of this standard. Huasong crane.
This standard was first published in.1997.
introduction
The purpose of this standard is to use a syringe (hereinafter referred to as injection needle) of the nominal diameter of the specified color, so that rapid visual recognition. which is
So that the needle or packaging on the color code, the user is still responsible for checking the injection needle marked specifications.
The color used as an injection needle color can be opaque or transparent, and the color is equally applicable to normal walls, thin walls and
Ultra-thin wall of the needle. The nominal diameter of the injection needle listed and given in this standard is the nominal outer diameter of the syringe specified in GB 15811. But this
Does not mean that all listed outside the nominal diameter of the injection needle are currently produced.
This standard only specifies the color code, but does not require the injection needle should be colored, and does not specify the color should be marked in the needle and/or packaging which
Part of it. Such requirements may be specified in the relevant product standards as in GB 18457.
The technical committee responsible for the development of this standard examines the use of instrument-measured color zones in the previous versions when specifying opaque colors
(Chroma and brightness index) and it is not practical to confirm that the instrument is measured. Measure the color area of the opaque color, especially the size of the needle
And the shape of the object opaque color of the color area is a complex process; the required equipment and expertise is only in a small number of laboratories and
The laboratory is available. It is inconvenient and difficult for the producer and the purchaser to assess whether a product meets the color zone value on a daily basis
, And even impossible, for translucent color, this difficulty is more prominent, and injection needle factory is increasingly using semi-permeable
Brighten the color so that you can see the bubbles inside the needle and remove it before injecting it.
Therefore, the color in this standard is defined by the name, and it is recognized that in the conformity assessment inevitably the introduction of some subjective
Minute. If, under controlled lighting conditions (eg illuminated at 1000lx ~ 1500lx "Daylight" D65), check the needle seat and use the
Medical proof of the correct color vision of the assessor, this subjectivity can be reduced to a minimum, the color of the product and the control color samples
Comparison, both simple and fast, so the evaluation of the product is a practical and conventional method. Moreover, the control color has been supplied. These pairs
The color is made in the form of a color set that conforms to this standard. See Appendix B for details and should be noted that the control sample is only included
There is a diameter of the needle (ie, 0.3 mm to 1.2 mm nominal outer diameter) of the color needle, and it is desirable that the diameter range included in the control color
Timely expansion.
One-time use of injection needle to identify the color
1 Scope
This standard specifies the nominal diameter from 0.3mm to 3.4mm one-time use of injection needle identification with color.
This standard applies to normal walls, thin-walled and ultra-thin-walled needles as well as opaque colors and translucent colors.
2 color standard
The color given in Table 1 indicates the nominal outer diameter of the needle.
Table 1
The nominal diameter of the needle
mm
Colour
0.3 yellow
0.33 red
0.36 blue-green
0.4 in the gray
0.45 brown
0.5 orange
0.55 in the purple
0.6 dark blue
0.7 black
0.8 dark green
0.9 yellow
1.1 Creamy
1.2 pink
1.6 white
1.8 Blue - Gray
2.1 light green
2.4 Purple
2.7 light blue
3 green - blue
3.4 olive brown
Note 1. Be careful to select a control needle seat that is available as a control color (see Appendix A).
Note 2. Appendix B and Appendix C give the color area of the opaque color and the closest chromatogram in some chromatograms, for reference.
(Informative)
Control color samples
The control colors referred to in this standard may be obtained in contact with the following units.
Melab
MedizintechnikundlaborGmbH
Molenbachstrasse19
71229Leonberg
Germany
info@melab.de
Appendix B
(Informative)
Opaque color area
B.1 The chromaticity (x, y) and the brightness are measured by an isometric distance method (Δλ = 10 nm) using a spectrophotometer under the following conditions.
Number r (β = 10-2r).
a) Illumination and determination conditions. Except for spectacular eyes according to the International Commission on Illumination (CIE) No.15.2;
b) Colorimetric Observation Control. According to CIE Publication No. 15.2, 2 °;
c) Luminescent material. according to CIE publication No. 15.2, C light source;
d) control white. barium sulfate plate near the complete reflection of the diffuse surface.
Table B.1 Color areas of opaque colors
The nominal diameter of the needle
mm
Color area
0.3 yellow
x = 0.448 x = 0.507
y = 0.468 y = 0.492
β> 0.40
x = 0.488 x = 0.468
0.33 red
x = 0.540 x = 0.560
y = 0.326 y = 0.280
0.10 x = 0.500 x = 0.610
y = 0.289 y = 0.330
0.36 blue-green
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 in the gray
x = 0.302 x = 0.323
y = 0.314 y = 0.315
0.20 & lt; β & lt; 0.50
x = 0.313 x = 0.303
y = 0.324 y = 0.302
0.45 brown
y = 0.332 y = 0.338
0.04 & lt; β & lt; 0.15
x = 0.440 x = 0.367
y = 0.356 y = 0.325
Table B.1 (continued)
The nominal diameter of the needle
mm
Color area
0.5 orange
y = 0.394 y = 0.394
0.22 x = 0.542 x = 0.498
y = 0.421 y = 0.375
0.55 in the purple
x = 0.258 x = 0.294
y = 0.193 y = 0.243
0.07 x = 0.274 x = 0.285
0.6 dark blue
x = 0.151 x = 0.203
y = 0.178 y = 0.182
0.05 x = 0.197 x = 0.164
y = 0.218 y = 0.132
0.7 black
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 dark green
x = 0.013 x = 0.310
y = 0.745 y = 0.441
0.09 x = 0.310 x = 0.254
y = 0.685 y = 0.397
0.9 yellow
y = 0.468 y = 0.492
β> 0.40
x = 0.448 x = 0.468
y = 0.511 y = 0.456
1.1 cream
x = 0.331 x = 0.377
y = 0.341 y = 0.364
0.65 x = 0.356 x = 0.341
1.2 pink
x = 0.328 x = 0.407
y = 0.308 y = 0.338
0.40 x = 0.332 x = 0.373
y = 0.321 y = 0.282
Table B.1 (continued)
The nominal diameter of the needle
mm
1.4 red - purple
x = 0.300 x = 0.320
y = 0.287 y = 0.270
0.40 x = 0.288 x = 0.316
y = 0.254 y = 0.293
1.6 white
x = 0.297 x = 0.330
y = 0.308 y = 0.318
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