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YY/T 0296-2013 English PDF (YY/T 0296-2022 Newer Version)

YY/T 0296-2013 (YY/T0296-2013, YYT 0296-2013, YYT0296-2013)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0296-2022English170 Add to Cart 0--9 seconds. Auto-delivery Hypodermic needles for single use - Colour coding for identification Valid YY/T 0296-2022
YY/T 0296-2013English150 Add to Cart 0--9 seconds. Auto-delivery Hypodermic needles for single use. Colour coding for identification Obsolete YY/T 0296-2013
YY/T 0296-1997English439 Add to Cart 3 days [Need to translate] Hypodermic needles for single use. Colour coding for identification Obsolete YY/T 0296-1997
Preview PDF: YY/T 0296-2022    Standards related to: YY/T 0296-2013

BASIC DATA
Standard ID 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 11,176
Older Standard (superseded by this standard) YY/T 0296-1997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 0296-2022 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. ......