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YY/T 0296-2022 PDF in English


YY/T 0296-2022 (YY/T0296-2022, YYT 0296-2022, YYT0296-2022)
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Standards related to: YY/T 0296-2022

YY/T 0296-2022: PDF in English (YYT 0296-2022)

YY/T 0296-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
YY/T 0296-2022 / ISO 6009:2016
Replacing YY/T 0296-2013
Hypodermic needles for single use - Colour coding for
identification
(ISO 6009:2016, IDT)
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 Colour code ... 6
Annex A (informative) Reference colour samples ... 8
Bibliography ... 11
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020
"Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents".
This document replaces YY/T 0296-2013 "Hypodermic needles for single use - Colour
coding for identification". Compared with YY/T 0296-2013, in addition to the structural
and editorial changes, the main technical changes in this document are as follows:
a) Add requirements that the nominal dimensions of the needle tube are 0.18 mm,
0.2 mm, 0.23 mm, and 0.25 mm (see Table 1 in Chapter 1 and Chapter 4 of this
Edition; Table 1 in Chapter 1 and Chapter 2 of Edition 2013);
b) Change the color requirements for needle tubes with a nominal size of 3 mm (see
Table 1 in Chapter 4 of this Edition; Table 1 in Chapter 2 of Edition 2013);
c) Add requirements for extremely thin-walled needles (see Table 1 in Chapter 4 of
this Edition);
d) Change Annex A (see Annex A of this Edition; Annex A for Edition 2013);
e) Delete Annex B (see Annex B of Edition 2013);
f) Delete Annex C (see Annex C of Edition 2013).
This document uses translation method to identically adopt ISO 6009:2016
"Hypodermic needles for single use - Colour coding for identification".
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority shall not be held responsible for
identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on
Medical Syringe (Needle) of Standardization Administration of China (SAC/TC 95).
The drafting organizations of this document: Shandong Weigao Group Medical
Polymer Products Co., Ltd., Shanghai Medical Device Inspection and Research
Institute, Zhejiang Kindly Medical Device Co., Ltd., Anhui Food and Drug Inspection
Institute, Chengdu Xinjin Shifeng Medical Device Co., Ltd.
Main drafters of this document: Li Weiyang, Liu Xinglin, Hua Songhe, Zhang Qian,
Huang Baohua, Tian Xinglong.
Versions of standard substituted by this document are:
Hypodermic needles for single use - Colour coding for
identification
1 Scope
This International Standard establishes a colour code for the identification of single-use
hypodermic needles of designated metric size in the range of 0.18 mm to 3.4 mm. It
applies to regular-walled (RW), thin-walled (TW), extra-thin-walled (ETW) and ultra-
thin-walled (UTW) needles, and to opaque and translucent colours.
This International Standard is not applicable to pen-needles.
2 Normative references
This document has no normative references.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 designated metric size
outer diameter designation of the tubing as defined in Table 1
NOTE: The unit is mm.
3.2 gauge
legacy size designation
NOTE: A particular gauge size corresponds to a designated metric size defining limits for outer
diameters.
4 Colour code
The colour shall indicate the nominal outer diameter of the tube of the needle and shall
be as given in Table 1.
Annex A contains certain guidance to commonly applied colour reference systems for
opaque materials.
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.