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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 1045-2021 is the Chinese standard "Dentistry - Handpieces and motors". Its scope clause reads: This document specifies requirements, test methods for handpieces and motors of various structures used in the treatment of dental patients and in contact with patients, and also specifies Manufacturer's information, marking requirements.

This document applies to. a) Straight handpieces and curved handpieces; b) high-speed gas turbine handpiece; c) air motor; d) electric motors; e) Polish the phone.

This document does not apply to. --- Oral camera phone; ---Light curing mobile phone; ---Pneumatic scaler; --- Electric scaler; --- Sandblasting mobile phone; ---Multifunctional spray gun.

NOTE. Appendix A clarifies the types of handpieces and motors covered by this document.

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Document preview — YY 1045-2021

National Standard of the People's Republic of China

Classification: C33

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Mobile phone classification
5 Requirements and performance
5.1 General requirements
5.2 Drop test
5.3 Noise level
5.4 Power source
5.5 Air and water pressure
5.6 Temperature
5.7 Repeat handling tolerance
5.8 Leakage and/or liquid ingress
5.9 Electromagnetic compatibility
5.10 Controller
5.11 Connection and Supply
5.12 Collet system for rods
5.13 Test stick
5.14 Speed
5.15 Radial runout
5.16 Stall torque
5.17 Head and Front Dimensions
5.18 Output power of high-speed gas turbine handpiece
5.19 Mobile phone with light
6 Sampling
7 Test
7.1 General test conditions
7.2 Visual inspection
7.3 Power
7.4 Air source
7.5 Spray air source
7.6 Water source
7.7 Air and water pressure
7.8 Motor cooling air
7.9 Mobile phone cooling air
7.10 Connection of mobile phone and motor
7.11 Connection and supply
7.12 Test rod
7.13 Collets for rods
7.14 Head and Front Dimensions
7.15 Radial runout
7.16 Stall torque
7.17 Noise levels
7.18 Speed
7.19 Case temperature rise
7.20 Overtemperature
7.21 Repeat handling tolerance
7.22 Output power of high-speed gas turbine handpieces
7.23 Mobile phone with light
8 Instructions for use, maintenance and service
9 Technical Specifications
10 mark
10.1 Overview
10.2 Mobile phones
10.3 Motor
11 Tags
Appendix A (Informative) Classification Tree for Cell Phones and Motors
Appendix B (Informative) Test Report Format

1 Scope

This document specifies requirements, test methods for handpieces and motors of various structures used in the treatment of dental patients and in contact with patients, and also specifies

Manufacturer's information, marking requirements.

This document applies to.

a) Straight handpieces and curved handpieces;

b) high-speed gas turbine handpiece;

c) air motor;

d) electric motors;

e) Polish the phone.

This document does not apply to.

--- Oral camera phone;

---Light curing mobile phone;

---Pneumatic scaler;

--- Electric scaler;

--- Sandblasting mobile phone;

---Multifunctional spray gun.

NOTE. Appendix A clarifies the types of handpieces and motors covered by this document.

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 1.Specification (GB/T 3785.1-2010, IEC 61672-1..2002, IDT)

GB/T 4340.1 Vickers Hardness Test for Metal Materials Part 1.Test Methods (GB/T 4340.1-2009, ISO 6507-

1.2005, MOD)

GB 9706.1-2020 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance (IEC 60601-

1.2012, MOD)

GB 9706.260-2020 Medical Electrical Equipment Part 2-60.Special Requirements for Basic Safety and Basic Performance of Dental Equipment (IEC 80601-2-60.2012, MOD)

GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD)

YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements (YY/T 0466.1-2016, ISO 15223-1.2012, IDT)

YY/T 0514 Hose connectors for dental pneumatic handpieces (YY/T 0514-2018, ISO 9168.2009, MOD) […]

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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

ISO 2768 · IEC 61672 · ISO 6507 · IEC 60601 · IEC 80601 · ISO 1942.2009 · ISO 15223 · ISO 9168.2009

Cited by

YY/T 1012-2021Dentistry—Coupling dimensions for handpiece connectors

Similar standards

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

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