YY/T 0296-2013 (YYT0296-2013)

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YY/T 0296-2013	English	145	Add to Cart	0--9 seconds. Auto-delivery	Hypodermic needles for single use. Colour coding for identification	YY/T 0296-2013	Valid	YY/T 0296-2013

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
1.4 red - purple
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.
Appendix A
(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
This message is provided only for the convenience of the user of this standard, not for the control of the color of the guarantee.
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.
B.2 Table B.1 shows the color area of the opaque color.
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
y = 0.511 y = 0.456
0.33 red
x = 0.540 x = 0.560
y = 0.326 y = 0.280
0.10 < ? < 0.20
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
0.30 < ? < 0.50
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
x = 0.360 x = 0.452
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
x = 0.482 x = 0.561
y = 0.394 y = 0.394
0.22 < ? < 0.40
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 < ? < 0.20
x = 0.274 x = 0.285
y = 0.237 y = 0.201
0.6 dark blue
x = 0.151 x = 0.203
y = 0.178 y = 0.182
0.05 < ? < 0.10
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
β & lt; 0.05
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 < ? < 0.20
x = 0.310 x = 0.254
y = 0.685 y = 0.397
0.9 yellow
x = 0.448 x = 0.507
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 < ? < 0.80
x = 0.356 x = 0.341
y = 0.372 y = 0.337
1.2 pink
x = 0.328 x = 0.407
y = 0.308 y = 0.338
0.40 < ? < 0.60
x = 0.332 x = 0.373
y = 0.321 y = 0.282
Table B.1 (continued)
The nominal diameter of the needle
mm
Color area
1.4 red - purple
x = 0.300 x = 0.320
y = 0.287 y = 0.270
0.40 < ? < 0.65
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
β> 0.80
x = 0.310 x = 0.303
y = 0.326 y = 0.295
1.8 Blue - Gray
x = 0.250 x = 0.295
y = 0.267 y = 0.314
0.10 < ? < 0.20
x = 0.262 x = 0.290
y = 0.309 y = 0.299
2.1 light green
x = 0.302 x = 0.320
y = 0.367 y = 0.369
0.45 < ? < 0.65
x = 0.337 x = 0.307
y = 0.376 y = 0.336
2.4 Purple
x = 0.329 x = 0.411
y = 0.233 y = 0.241
0.10 < ? < 0.20
x = 0.338 x = 0.376
y = 0.194 y = 0.267
2.7 Light blue
x = 0.197 x = 0.291
y = 0.197 y = 0.306
0.20 < ? < 0.65
x = 0.200 x = 0.289
y = 0.260 y = 0.294
3 green - yellow
x = 0.350 x = 0.380
y = 0.525 y = 0.450
0.30 < ? < 0.50
x = 0.336 x = 0.420
y = 0.450 y = 0.525
3.4 olive brown
x = 0.402 x = 0.392
y = 0.443 y = 0.372
0.10 < ? < 0.25
x = 0.362 x = 0.454
y = 0.386 y = 0.415
Appendix C.
(Informative)
Opaque color
Table C.1 shows the closest color to the color specified in this standard.
Table C.1
The nominal diameter of the needle
mm
Color sample
Montessori Color Standard American Standard 595a German Standard DAL840HR French Standard NFX08-002
0.3 3.75Y8/14 23.655 1.021 1.330
0.33 - - - -
0.36 7.5GB 5/8 - - -
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 2.5BB3/8 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
1.2 2.5R7/6 11630 3015 2870
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 - - - -
references
[1] ISO 7864. 1988, Sterilehypodermicneedlesforsingleuse.
[2] ISO 9626..1991.Stainlesssteelneadlefubingforthemanufactureofmedicaldevices.
[3] CIEPublicationNo.15.2. 1986, Colorimetry.
[4] MunselBookofColor.
[5] USAFederalStandard595a, Colors-Vol.1.
[6] GermanStandardRAL840.HRFarbregister (Colorreglster).
[7] FrenchStandardNFX08-002.Collectionreduitedescouleurs-Designationetcataloguedes
couleursCCR-Etaionssecondaires (Limiledcollectlonofcolours-Designation andcata-logueofCCR
colours-SecondaryStandards).