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YY/T 1021.2-2023 English PDF

YY/T 1021.2-2023_English: PDF (YY/T1021.2-2023)
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YY/T 1021.2-2023English199 Add to Cart 3 days [Need to translate] Dentistry - Extraction forceps - Part 2: Designation Valid YY/T 1021.2-2023


BASIC DATA
Standard ID YY/T 1021.2-2023 (YY/T1021.2-2023)
Description (Translated English) Dentistry - Extraction forceps - Part 2: Designation
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.20
Word Count Estimation 10,124
Date of Issue 2023-09-05
Date of Implementation 2024-09-15
Drafting Organization Guangdong Medical Device Quality Supervision and Inspection Institute, Zhejiang Xinya Medical Technology Co., Ltd., Zhejiang Medical Device Inspection Institute
Administrative Organization National Dental Materials and Equipment Standardization Technical Committee Dental Equipment and Equipment Sub-Technical Committee (SAC/TC 99 SC 1)
Proposing organization State Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the labeling of dental extraction forceps. This standard applies to all dental extraction forceps.


YY/T 1021.2-2023. Dental extraction forceps Part 2. Labeling ICS 11.060.20 CCSC33 Pharmaceutical Industry Standards of the People's Republic of China Dental extraction forceps Part 2.Labeling (ISO 9173-2.2010,MOD) Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration Table of contents Preface III Introduction IV 1 range 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Mark 1 5 Tags, labels and catalog entries 4 Preface This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is part 2 of YY/T 1021 "Dental Extraction Forceps". YY/T 1021 has released the following parts. ---Part 1.General requirements; ---Part 2.Marking; ---Part 3.Design. This document has been modified to adopt ISO 9173-2.2010 "Dental extraction forceps - Part 2.Labeling". The technical differences between this document and ISO 9173-2.2010 and their reasons are as follows. ---Replaced ISO 3166-1 (see 4.3.3) with normatively quoted GB/T 2659.1 to adapt to my country's technical conditions and increase reliability operability; ---Replaced ISO 1942 (see Chapter 3) with normatively quoted GB/T 9937 to adapt to my country's technical conditions and increase operability. work nature; ---Replaced ISO 3950 (see 4.3.1) with normatively quoted GB/T 9938 to adapt to my country's technical conditions and increase operability work nature; ---Replaced ISO 9173-1 (see Chapter 3) with normatively quoted YY/T 1021.1 to adapt to my country's technical conditions and increase Operability; ---The two-character Latin alphabet code in GB/T 2659.1 does not include the code "UK" in Example 2 of 4.3.3.Use the The two-character Latin letter code "CN" of GB/T 2659.1 is replaced (see 4.3.3). Editorial changes have been made to this document and a statement of the scope of application of this document has been added. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is sponsored by the Dental Equipment and Equipment Sub-Technical Committee of the National Technical Committee for Standardization of Oral Materials and Equipment (SAC/TC99 SC1) Return to home. This document was drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Zhejiang Xinya Medical Technology Co., Ltd., Zhejiang Medical Device Inspection Institute. The main drafters of this document. Chen Yuen, Ning Ruijian, Wu Weirong, Yuan Qin, Feng Zhimei, Chen Xianming, Yu Chongqing, Deng Qiyuan, Suning, Huang Mingqiao. introduction YY/T 1021 aims to establish basic requirements, marking methods and design criteria that are generally applicable to dental extraction forceps products, and consists of three parts. ---Part 1.General requirements, the purpose is to clarify the general requirements and test methods such as material properties and mechanical properties of dental extraction forceps. ---Part 2.Labeling, the purpose is to clarify the labeling rules and labeling methods of dental extraction forceps. ---Part 3.Design, the purpose is to clarify the classification and design specifications of dental extraction forceps. Dental extraction forceps are used to remove teeth. Most tooth extraction forceps can be used on both jaws and on more than one type of tooth, for example, on the front of the maxilla or mandible. Molar, suitable for maxillary central incisors and maxillary canines (or larger lateral incisors), suitable for upper lateral incisors, suitable for maxillary deciduous incisors and canines Teeth. Some maxillary molar forceps and some mandibular third molar forceps are specifically designed to address the characteristics of these teeth and related aspects. some tooth extractions Forceps are used only on the root of the tooth. In order for dentists and/or their assistants to order the correct dental extraction forceps for the intended clinical purpose, a global labeling system is required. Dental extraction forceps Part 2.Labeling 1 Scope This document specifies the labeling of dental extraction forceps. This document applies to all dental extraction forceps. 2 Normative reference documents The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 2659.1 Names and codes of countries and regions around the world and their administrative regions Part 1.Country and region codes (GB/T 2659.1- 2022,ISO 3166-1.2020,MOD) GB/T 9937 Dental terminology (GB/T 9937-2020, ISO 1942.2009, MOD) GB/T 9938 Method for marking dental tooth positions and oral areas (GB/T 9938-2013, ISO 3950.2009, IDT) YY/T 1021.1 Dental extraction forceps Part 1.General requirements (YY/T 1021.1-2022, ISO 9173-1.2016, MOD) 3 Terms and definitions The terms and definitions defined in GB/T 9937, YY/T 1021.1 and the following apply to this document. 3.1 Pattern numberpatternnumber The specific type number of dental extraction forceps is determined by the manufacturer. 3.2 Labeling of dental extraction forceps based on intended clinical use. 4 mark 4.1 General The type number and function label of the dental extraction forceps should be marked. Label = type number [function label] 4.2 Type number The type number should be the traditional numeric (type) number used by the extraction forceps manufacturer's country of origin (e.g., 4.3 Functional indication 4.3.1 General The function label information of dental extraction forceps provided in this document is intended to guide clinical personnel in selecting and using dental extraction forceps. ......

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