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YY/T 1021.1-2022: Dentistry - Extraction forceps - Part 1: General requirements
Status: Valid YY/T 1021.1: Evolution and historical versions
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Dentistry - Extraction forceps - Part 1: General requirements
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PDF similar to YY/T 1021.1-2022
Basic data | Standard ID | YY/T 1021.1-2022 (YY/T1021.1-2022) | | Description (Translated English) | Dentistry - Extraction forceps - Part 1: General requirements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 10,184 | | Issuing agency(ies) | State Drug Administration | YY/T 1021.1-2022: Dentistry - Extraction forceps - Part 1: General requirements---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Dentistry - Extraction forceps - Part 1.General requirements
ICS 11.060.20
CCSC33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1021-2005
dental extraction forceps
Part 1.General Requirements
(ISO 9173-1.2016, MOD)
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface I
Introduction III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 2
5 Test method 3
6 Flags 4
Reference 5
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is part 1 of YY/T 1021-2022 "Dental extraction forceps". YY/T 1021 has issued the following parts.
--- Part 1.General requirements.
This document replaces YY/T 1021-2005 "Tooth Extraction Forceps". Compared with YY/T 1021-2005, except for structural adjustments and editorial changes
In addition, the main technical changes are as follows.
--- Changed the scope (see Chapter 1, Chapter 1 of the.2005 edition);
--- Delete the classification (see Chapter 3 of the.2005 edition);
--- Added terms and definitions (see Chapter 3);
--- Increased material requirements (see 4.1);
--- Changed the size requirements (see 4.2, 5.2, 4.3 of the.2005 edition);
--- Change the hardness requirements and test methods (see 4.3, 5.2, 4.4, 5.4 of YY/T 1021-2005);
--- Changed the appearance requirements and test methods (see 4.4, 5.3, 4.9, 4.10, 5.9 of YY/T 1021-2005);
--- Changed the stability requirements and test methods for recycling (see 4.5, 5.4, 4.8, 5.8 of YY/T 1021-2005);
--- Change the joint opening/closing force requirements and test methods (see 4.6, 5.5, 4.2, 5.2 of YY/T 1021-2005);
--- Changed joint motion requirements and test methods (see 4.7, 5.6, 4.1, 5.1 of YY/T 1021-2005);
--- Changed the strength requirements and test methods (see 4.8, 5.7, 4.5, 5.5 of YY/T 1021-2005);
--- Changed the surface roughness requirements (see 4.9, 4.7 of YY/T 1021-2005);
--- Delete the sharpness test requirements and test methods (see 4.6, 5.6 of YY/T 1021-2005);
--- Delete the inspection rules (see Chapter 6 of YY/T 1021-2005);
--- Changed the logo (see Chapter 6, Chapter 7 of YY/T 1021-2005);
--- Deleted the packaging, transportation and storage (see Chapter 8 of YY/T 1021-2005).
This document is revised and adopted ISO 9173-1.2016 "Dental extraction forceps - Part 1.General requirements". with ISO 9173-1.2016
Compared, the main technical differences are as follows.
--- Regarding normative reference documents, this document has been adjusted to suit the technical conditions of our country and to facilitate the implementation of this document.
The situation is concentrated in Chapter 2 "Normative References", and the specific adjustments are as follows.
● Replace ISO 6508-1 with GB/T 230.1 which has been modified to adopt international standards;
● Replace ISO 1942 with GB/T 9937 which is equivalent to adopting international standards;
● Replacing ISO 17644 with YY/T 0802 which has been modified to adopt international standards;
--- Add the specific test methods corresponding to 4.2 and 4.3 to make the standard structure more complete;
--- Changed the description of the requirements in 4.4~4.6 to make the requirements more concise and clear;
--- Changed the torque requirements in 4.6 to conform to my country's national conditions;
---Add the requirements of 4.8 and 4.9 and the corresponding test methods, and retain the original domestic industry standard YY/T 1021-2005 that is reasonable
terms;
--- Changed the requirements and corresponding test methods in 4.5 to further clarify the specific experimental operation.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is approved by the National Dental Equipment and Equipment Sub-Technical Committee of the National Standardization Technical Committee for Oral Materials and Devices (SAC/TC99
SC1) focal point.
This document is drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Zhejiang New Asia Medical Technology Co., Ltd., Shanghai Medical
Instrument Testing Institute.
The main drafters of this document. Hu Xianghua, Ning Ruijian, Chen Xianming, Yuan Qin, Zhang Lihua, Hua Songhe.
The previous versions of this document and its superseded documents are as follows.
---YY/T 1021-2005 "Tooth Extraction Forceps";
---YY 91021-1999 "Tooth Extraction Forceps for Adults" and YY 91022-1999 "Tooth Extraction Forceps for Children".
Introduction
YY/T 1021 aims to establish the basic requirements, marking methods and design criteria that are generally applicable to tooth extraction forceps products. It is planned to consist of three parts.
constitute.
--- Part 1.General requirements. The purpose is to establish general requirements and corresponding test methods that tooth extraction forceps products need to comply with.
--- Part 2.Marking. The purpose is to standardize the labeling method of tooth extraction forceps and the tooth position/oral area and specific functions of tooth extraction forceps.
These two aspects of the unified marking rules.
--- Part 3.Design. The purpose is to standardize extraction forceps from five aspects. joint design, shape of forceps beak, shape of forceps handle, and expected application.
The classification rules are given, and the names and measurement guidelines of the dimensions of each part of the tooth extraction forceps are given.
dental extraction forceps
Part 1.General Requirements
1 Scope
This document specifies general performance requirements and test methods for dental extraction forceps.
This document applies to all dental extraction forceps.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 230.1 Rockwell hardness test of metallic materials Part 1.Test method (GB/T 230.1-2018, ISO 6508-1.
2016, MOD)
GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD)
YY/T 0802 Treatment of medical devices Information provided by medical device manufacturers (YY/T 0802-2020, ISO 17664.
3 Terms and Definitions
The terms and definitions defined in GB/T 9937 and the following apply to this document.
3.1
extraction forceps
Pliers for tooth extraction.
3.2
beak beak
The functional working end of the extraction forceps for holding teeth.
3.3
facialbeak
Beaks designed to make buccal contact with teeth.
3.4
lingualbeak
Beaks designed to be in contact with the lingual surface of the teeth.
3.5
beak separation
The minimum distance between the tips of the beaks of the forceps when the forceps are closed.
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