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YY 1045-2021Dentistry - Handpieces and motors (English PDF)

牙科学 手机和马达

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

September 6, 2021

Implementation date

May 1, 2024

Scope

YY 1045-2021 is the English-translated version of 牙科学 手机和马达.

YY 1045 is the mandatory Chinese standard for dental handpieces and motors, consolidating what was previously a multi-part series into one document. It covers the whole family: high-speed air turbines, low-speed straight and contra-angle handpieces, and the electric and air motors that drive them. The standard sets the requirements they have to meet and the test methods that verify them, covering the couplings and their interchangeability, bur retention, concentricity and runout, the coolant supply, noise and vibration, and the resistance to repeated sterilization that determines how long an instrument survives in practice. Handpieces are the most heavily used and most frequently reprocessed instruments in dentistry. Being a YY standard without the /T suffix, compliance is compulsory in China. It takes effect in May 2024.

Document preview — YY 1045-2021

National Standard of the People's Republic of China

Classification
C33

Issued by: National Medical Products Administration

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions

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 replaces YY 0836-2011 "Dental low-voltage electric motor for dental handpieces", YY 0837-2011 "Dental handpieces for dental gas Moving Motor", YY 1045.1-2009 "Dental Handpiece Part

1 Scope

YY 1045 is the mandatory Chinese standard for dental handpieces and motors, consolidating what was previously a multi-part series into one document. It covers the whole family: high-speed air turbines, low-speed straight and contra-angle handpieces, and the electric and air motors that drive them. The standard sets the requirements they have to meet and the test methods that verify them, covering the couplings and their interchangeability, bur retention, concentricity and runout, the coolant supply, noise and vibration, and the resistance to repeated sterilization that determines how long an instrument survives in practice. Handpieces are the most heavily used and most frequently reprocessed instruments in dentistry. Being a YY standard without the /T suffix, compliance is compulsory in China. It takes effect in May 2024.

2.Straight and Curved Handsets." Main differences between this document and YY 0836-2011, YY 0837-2011, YY 1045.1-2009, YY 1045.2-2010 as follows:

--- Changed the scope of application, added 5 applicable products and 6 inapplicable products, and added Appendix A in the form of a diagram The formula lists the mobile phone and motor classification;

--- Added and changed normative references;

--- Added and changed terms and definitions;

--- Added Appendix B, giving an example of a test report. Compared with YY 0836-2011, the main changes of this document are as follows:

--- Changed the general requirements (see 5.1,

5.1.1 of YY 0836-2011);

--- Changed the drop test (see 5.2,

5.1.1.1 of YY 0836-2011);

--- Changed the noise level (see 5.3,

5.2.9 of YY 0836-2011);

--- Changed the power source (see 5.4, 5.1.2, 5.2.1,

5.2.3 of YY 0836-2011);

--- Increased air pressure and water pressure (see 5.5);

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 1184 Shape and Position Tolerance No tolerance value ( GB/T 1184-1996, ISO 2768-2.1989, eqv)

GB/T 1804 General Tolerances Unmarked Tolerances for Linear and Angular Dimensions ( GB/T 1804-2000, ISO 2768- 1.1989, eqv)

GB/T 3785.1 Electroacoustic Sound Level Meter Part

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 62 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 1184-1996 · ISO 2768 · GB/T 1804-2000 · GB/T 3785.1-2010 · IEC 61672 · GB/T 4340.1-2009 · ISO 6507 · IEC 60601 · GB 9706.260-2020 · IEC 80601 · GB/T 9937-2020 · ISO 1942.2009 · ISO 15223 · YY/T 0514-2018 · ISO 9168.2009

Similar standards

YY 1042|YY/T 0823|YY/T 0824|YY/T 1043.1

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