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YY/T 1021.1-2022Dentistry—Extraction forceps - Part 1: General requirements (English PDF)

牙科学 拔牙钳 第1部分:通用要求

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 18, 2022

Implementation date

June 1, 2023

Scope

YY/T 1021.1-2022 is the English-translated version of 牙科学 拔牙钳 第1部分:通用要求.

YY/T 1021.1-2022 is the Chinese pharmaceutical industry standard that sets the general performance requirements for dental extraction forceps and the test methods for them.

It is the first part of the YY/T 1021 series and applies to all extraction forceps, covering the materials and their corrosion resistance, the hardness and finish of the beaks and their alignment when closed, the strength of the joint and the handles, and the durability of the instrument under repeated use, together with the marking.

It replaces YY/T 1021-2005, was issued on 18 May 2022 and has applied since 1 June 2023.

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Document preview — YY/T 1021.1-2022

National Standard of the People's Republic of China

Classification
C 33
Replacing
YY/T 1021-2005

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Requirements
  • 5 Test method
  • 6 Flags
  • Reference

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.

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Editions of YY/T 1021.1

EditionTitleRevisionStatus
YY/T 1021.1-2022Dentistry—Extraction forceps - Part 1: General requirementscurrent editionCurrent
YY/T 1021-2005Dentistry—Extraction forceps - Part 1: General requirementsprevious editionSuperseded

This page sells the current edition, YY/T 1021.1-2022. Earlier editions are listed for reference only.

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