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YY 1045-2021: (Dentistry cell phone and motor)
Status: Valid YY 1045: Evolution and historical versions
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(Dentistry cell phone and motor)
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YY 1045-2021
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| YY 1045.1-2009 | English | 439 |
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Dental handpieces. Part 1: High-speed air turbine handpieces
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YY 1045.1-2009
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PDF similar to YY 1045-2021
Standard similar to YY 1045-2021 YY 1042 YY/T 0823 YY/T 0824 YY/T 1043.1 Basic data | Standard ID | YY 1045-2021 (YY1045-2021) | | Description (Translated English) | (Dentistry cell phone and motor) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Word Count Estimation | 37,367 | | Issuing agency(ies) | State Drug Administration | YY 1045-2021: (Dentistry cell phone and motor)---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 cell phone and motor)
ICS 11.060.25
CCSC33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0836-2011, YY 0837-2011, YY 1045.1-2009, YY 1045.2-2010
Dental Handpieces and Motors
Published on 2021-09-06
2024-05-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction VII
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Mobile phone classification 4
5 Requirements and performance 4
5.1 General requirements 4
5.2 Drop test 4
5.3 Noise level 4
5.4 Power source 4
5.5 Air and water pressure 5
5.6 Temperature 6
5.7 Repeat handling tolerance 6
5.8 Leakage and/or liquid ingress 7
5.9 Electromagnetic compatibility 7
5.10 Controller 7
5.11 Connection and Supply 7
5.12 Collet system for rods 9
5.13 Test stick 9
5.14 Speed 11
5.15 Radial runout 11
5.16 Stall torque 11
5.17 Head and Front Dimensions 11
5.18 Output power of high-speed gas turbine handpiece 12
5.19 Mobile phone with light 12
6 Sampling 13
7 Test 13
7.1 General test conditions 13
7.2 Visual inspection 13
7.3 Power 13
7.4 Air source 13
7.5 Spray air source 13
7.6 Water source 14
7.7 Air and water pressure 14
7.8 Motor cooling air 14
7.9 Mobile phone cooling air 15
7.10 Connection of mobile phone and motor 16
7.11 Connection and supply 16
7.12 Test rod 16
7.13 Collets for rods 16
7.14 Head and Front Dimensions 17
7.15 Radial runout 17
7.16 Stall torque 17
7.17 Noise levels 17
7.18 Speed 18
7.19 Case temperature rise 18
7.20 Overtemperature 18
7.21 Repeat handling tolerance 19
7.22 Output power of high-speed gas turbine handpieces 19
7.23 Mobile phone with light 20
8 Instructions for use, maintenance and service21
9 Technical Specifications 21
10 mark 22
10.1 Overview 22
10.2 Mobile phones 22
10.3 Motor 22
11 Tags 22
Appendix A (Informative) Classification Tree for Cell Phones and Motors 23
Appendix B (Informative) Test Report Format 24
Reference 28
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.High-speed Gas Turbine Handpiece", YY 1045.2-2010 "Dental Handpiece No.
Part 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, 5.2.2 and 5.2.3 of YY 0836-2011);
--- Increased air pressure and water pressure (see 5.5);
--- Changed the temperature (see 5.6, 5.1.6 of YY 0836-2011);
--- Modified repeated treatment tolerance (see 5.7, 5.1.5 of YY 0836-2011);
--- Increased leakage and/or ingress (see 5.8);
--- Changed electromagnetic compatibility (see 5.9, 5.3.14 of YY 0836-2011);
--- Changed the controller (see 5.10, 5.1.3 and 5.2.7 of YY 0836-2011);
--- Changed the connection and supply (see 5.11, 5.2.4 of YY 0836-2011);
--- Changed the speed (see 5.14, 5.2.6 of YY 0836-2011);
--- Delete the classification (see 4 of YY 0836-2011);
--- Delete faces, corners and edges (see 5.1.1.2 of YY 0836-2011);
--- Deleted disinfection and cleaning (see 5.1.4 of YY 0836-2011);
--- Deleted the corrosion resistance (see 5.1.7 of YY 0836-2011);
--- Delete the light source (see 5.2.5 of YY 0836-2011);
--- Deleted torque (see 5.2.8 of YY 0836-2011).
Compared with YY 0837-2011, the main changes of this document are as follows.
--- Changed the general requirements (see 5.1, 5.1.1 and 5.1.2 of YY 0837-2011);
--- Changed the drop test (see 5.2, 5.1.1.1 of YY 0837-2011);
--- Changed the noise level (see 5.3, 5.2.10 of YY 0837-2011);
--- Changed the power source (see 5.4, 5.2.1, 5.2.2 and 5.2.3 of YY 0837-2011);
--- Changed the air pressure and water pressure (see 5.5, 5.2.11 of YY 0837-2011);
--- Changed the temperature (see 5.6, 5.1.6 of YY 0837-2011);
--- Changed repeated treatment tolerance (see 5.7, 5.1.5 of YY 0837-2011);
--- Increased leakage and/or ingress (see 5.8);
--- Changed the controller (see 5.10, 5.1.3 and 5.2.8 of YY 0837-2011);
--- Changed the connection and supply (see 5.11, 5.2.4 and 5.2.5 of YY 0837-2011);
--- Changed the speed (see 5.14, 5.2.7 of YY 0837-2011);
--- Delete the classification (see 4 of YY 0837-2011);
--- Delete faces, corners and edges (see 5.1.1.2 of YY 0837-2011);
--- Deleted disinfection and cleaning (see 5.1.4 of YY 0837-2011);
--- Deleted corrosion resistance (see 5.1.7 of YY 0837-2011);
--- Deleted the light power supply (see 5.2.6 of YY 0837-2011);
--- Deleted the braking torque (see 5.2.9 of YY 0837-2011).
Compared with YY 1045.1-2009, the main changes of this document are as follows.
--- Changed the mobile phone classification (see 4, 4 of YY 1045.1-2009);
--- Changed the general requirements (see 5.1, 5.1.1 and 5.1.3 of YY 1045.1-2009);
--- Added drop test (see 5.2);
--- Changed the noise level (see 5.3, 5.7 of YY 1045.1-2009);
--- Changed the power source (see 5.4, 5.4 of YY 1045.1-2009);
--- Changed the air pressure and water pressure (see 5.5, 5.6 of YY 1045.1-2009);
--- Changed repeated treatment tolerance (see 5.7, 5.9 of YY 1045.1-2009);
--- Increased leakage and/or ingress (see 5.8);
--- Added controller (see 5.10);
--- Changed the connection and supply (see 5.11, 5.5 of YY 1045.1-2009);
--- Changed the chuck system of the rod (see 5.12, 5.2.3, 5.2.4 and 5.2.5 of YY 1045.1-2009);
--- Changed the test bar (see 5.13, 5.2.1 of YY 1045.1-2009);
--- Changed the speed (see 5.14, 5.3.1 of YY 1045.1-2009);
--- Changed the radial runout (see 5.15, 5.2.6 of YY 1045.1-2009);
--- Changed the stall torque (see 5.16, 5.3.2 of YY 1045.1-2009);
--- Changed the size of the head and front end (see 5.17, 5.1.4 of YY 1045.1-2009);
--- Increased the output power of the high-speed gas turbine handpiece (see 5.18);
--- Added mobile phone with light (see 5.19);
--- Deleted the corrosion resistance (see 5.8 of YY 1045.1-2009);
--- Deleted the lighting power supply (see 5.10 of YY 1045.1-2009).
Compared with YY 1045.2-2010, the main changes of this document are as follows.
--- Changed the mobile phone classification (see 4, 4 of YY 1045.2-2010);
--- Changed the general requirements (see 5.1, 5.1.1 and 5.1.3 of YY 1045.2-2010);
--- Added drop test (see 5.2);
--- Increased noise level (see 5.3);
--- Changed the power source (see 5.4, 5.3 of YY 1045.2-2010);
--- Increased air pressure and water pressure (see 5.5);
--- Changed the temperature (see 5.6, 5.6 of YY 1045.2-2010);
--- Changed repeated treatment tolerance (see 5.7, 5.5 of YY 1045.2-2010);
--- Increased leakage and/or ingress (see 5.8);
--- Added controller (see 5.10);
--- Changed the connection and supply (see 5.11, 5.4 of YY 1045.2-2010);
--- Changed the chuck system of the rod (see 5.12, 5.2 of YY 1045.2-2010);
--- Increase the test rod (see 5.13);
--- Increased the speed (see 5.14);
--- Changed the radial runout (see 5.15, 5.2.6 of YY 1045.2-2010);
--- Changed the size of the head and front end (see 5.17, 5.1.4 of YY 1045.2-2010);
--- Added mobile phone with light (see 5.19);
--- Deleted corrosion resistance (see 5.7 of YY 1045.2-2010);
--- Deleted the light power supply (see 5.8 of YY 1045.2-2010).
This document uses the redrafting method to modify the adoption of ISO 14457.2017 "Dental handpieces and motors". This document is related to ISO 14457.
The technical differences for.2017 are as follows.
--- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.
● Deleted the ISO 5349-1 and ISO 5349-2 standards, due to the deletion of the original 5.9 vibration requirements;
● Deleted the IEC 62366-1 standard, due to the deletion of the original 5.14 usability requirements;
● Deleted the ISO 10993-1 standard, because the original 5.2 material requirements were deleted;
● Added the YY 9706.102 standard, which is included in the reference because of the original ISO text (see 5.9);
● Replacing ISO 1797 (all parts) with YY/T 0967 (all parts), [see 8c)], one between the parts of the two standards
The degree of consistency is as follows.
● YY/T 0967.1-2015 Dental Rotary Instrument Rods Part 1.Metal Rods (ISO 1797-1.1992, MOD);
● YY/T 0967.2-2015 Dental Rotary Instrument Rods Part 2.Plastic Rods (ISO 1797-2.1992, MOD);
● YY/T 0967.3-2016 Dental Rotary Instrument Rods Part 3.Ceramic Rods (ISO 1797-3.2013, MOD).
● Replacing ISO 1942 with GB/T 9937 modified to adopt international standards (see Chapter 3);
● Replace ISO 2768-1 with GB/T 1804 which is equivalent to international standard (see 5.11.3.2.3, 5.13);
● Replace ISO 2768-2 with GB/T 1184 which is equivalent to adopting international standards (see 5.11.3.2.3, 5.13);
● Replacing ISO 3964 with YY/T 1012 modified to adopt international standards (see 5.4.2.3, 5.11.3.1, Figure A.1);
● Replace ISO 6507-1 with GB/T 4340.1 modified to adopt international standards (see 7.12);
● Replacing ISO 7494-1 with YY/T 1043.1 modified to adopt international standards (see 5.4.1);
● Replacing ISO 9168 with YY/T 0514 modified to adopt international standards (see 5.11.2, Figure A.1);
● Replace ISO 9687 with YY/T 0628 which is equivalent to adopting international standards (see 5.10, 10.1, 11);
● Replacing ISO 13295 with YY/T 0913 modified to adopt international standards (see 5.12.1);
● Replace ISO 15223-1 with YY/T 0466.1 which is equivalent to adopting international standards (see 10.1, 11);
● Replacing ISO 17664 with YY/T 0802 modified to adopt international standards (see 8l));
● Replace ISO 21531 with YY/T 1501 which is equivalent to adopting international standards (see 10.1);
● Replace IEC 60601-1 with GB 9706.1 modified to adopt international standards (see 5.2, 5.4.1, 5.8, 5.10, 7.3);
● Replace IEC 61672-1 with GB/T 3785.1 which is equivalent to adopting international standards (see 7.17.1.1);
● Replace IEC 80601-2-60 with GB 9706.260 modified to adopt international standards (see 5.1, 5.4.1, 5.6.2.1, 5.6.3.1,
7.3, 7.19.1, 7.20.1);
the condition of standing power supply;
--- Deleted 5.2, because the choice of materials is determined by the manufacturer, and no specific product characteristic requirements are proposed, and the clause numbers after 5.2 are corresponding
Change;
--- Deleted the content of the IEC 62366-1 usability standard, involving clauses 5.1, 5.5, and 5.14;
--- Deleted 5.9, because vibration has been required in the GB 9706.1-2020 standard;
--- Added "if applicable" to the requirements of 5.11.3.1 Overview, 5.11.3.2.2 Dimensions and 5.11.3.2.3 Mandrels, since other connections are allowed
form;
--- Changed the test method of 7.13.1.2, from the original force measured by the determined moving distance to the one determined by applying
Force measures the moving distance, the principle is the same, but the inspection process is more maneuverable;
--- Changed the test method of 7.15.2, citing the test method of the old version of the standard, which is clearer and more operable;
--- Added the output power calculation formula in 7.22.2, which is given in the form of a note to clarify the output power of the high-speed gas turbine mobile phone
calculation method;
--- Changed the content of 8e) to clarify that the type of mobile phone and/or motor connection and the applicable standards are specified in the manual;
--- Removed Chapter 12 Packaging;
---Add GB/T 16886.1 and YY/T 1474 standards to the references.
Please note that some content of this document may be patented. The issuer 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.
The previous versions of the documents replaced by this document are as follows.
---YY 0836-2011;
---YY 0837-2011;
---GB 12133-1989, YY 91045-1999, YY 1045.1-2009;
---YY 1045.2-2010.
Introduction
If the materials of mobile phones and/or motors involve biological evaluation, see GB/T 16886.1.
See YY/T 1474 for availability of mobile phones and/or motors.
Dental Handpieces and Motors
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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