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YY/T 1691-2020 English PDF (YYT1691-2020)

YY/T 1691-2020 English PDF (YYT1691-2020)

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YY/T 1691-2020: Dentistry--Torque transmitter for handpieces

This Standard specifies the terms and definitions, classification, expected performance, performance attributes, performance evaluation, production, repetitive processing tolerance, information and test methods provided by the manufacturer of torque transmitters. This type of torque transmitter is used as an auxiliary device to be connected to a dental handpiece, which is used to place oral implants during oral implant surgeries and perform further operations on the connecting parts in the craniofacial region.
YY/T 1691-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.060.25
C 33
Dentistry - Torque Transmitter for Handpieces
(ISO 17509:2016, MOD)
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JUNE 1, 2021
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 7
4 Classification ... 7
5 Expected Performance ... 7
6 Performance Attributes ... 7
7 Performance Evaluation ... 10
8 Production ... 10
9 Repetitive Processing Tolerance ... 10
10 Information Provided by the Manufacturer ... 11
11 Test Methods ... 11
Foreword
This Standard was drafted in accordance with the rules provided in GB/T 1.1-2009. This Standard adopts the re-drafting law to modify the adoption of ISO 17509:2016 Dentistry - Torque Transmitter for Handpieces (English version).
In comparison with ISO 17509:2016, the main technical differences are as follows: ---The Foreword part of ISO is deleted.
---In accordance with the habits of Chinese expression, the sequence of paragraphs in ?€?Scope?€? is adjusted.
---In terms of Normative References, this Standard makes adjustments, so as to adapt to China?€?s technical conditions and facilitate the implementation of this Standard. The condition of the adjustments is intensively reflected in Chapter 2 ?€?Normative References?€?. See the specific adjustments below:
??? GB/T 4340.1, which is adopted in the modification, is used to replace ISO 6507-1 (see 6.3);
??? GB/T 6062, which is equivalently adopted, is used to replace ISO 3274 (see 6.1);
??? GB/T 9937 (all parts) is used to replace ISO 1942 (all parts) (see Chapter 3). The consistency between different parts of the two standards is as
follows:
??? GB/T 9937.1-2008 Dental Vocabulary - Part 1: General and Clinical
Terms (ISO 1942-1:1989, IDT);
??? GB/T 9937.2-2008 Dental Vocabulary - Part 2: Dental Materials (ISO
1942-2:1989, IDT);
??? GB/T 9937.3-2008 Dental Vocabulary - Part 3: Dental Instruments
(ISO 1942-3:1989, IDT);
??? GB/T 9937.4-2005 Dental Vocabulary - Part 4: Dental Equipment (ISO
1942-4:1989, IDT);
??? GB/T 9937.5-2008 Dental Vocabulary - Part 5: Terms Associated with
Testing (ISO 1942-5:1989, IDT);
??? GB/T 10610, which is equivalently adopted, is used to replace ISO 4288 (see 6.1);
Dentistry - Torque Transmitter for Handpieces
1 Scope
This Standard specifies the terms and definitions, classification, expected performance, performance attributes, performance evaluation, production, repetitive processing tolerance, information and test methods provided by the manufacturer of torque transmitters. This type of torque transmitter is used as an auxiliary device to be connected to a dental handpiece, which is used to place oral implants during oral implant surgeries and perform further operations on the connecting parts in the craniofacial region.
This Standard is applicable to torque transmitters that implant implants into or remove implants from the patient?€?s oral cavity. The torque transmitter is connected to a power- driven system equipped with a torque control function. This Standard does not include dental implants or components connected to dental implants.
This Standard is not applicable to the power-driven system itself.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 4340.1 Metallic Materials - Vickers Hardness Test - Part 1: Test Method (GB/T 4340.1-2009, ISO 6507-1:2005, MOD)
GB/T 6062 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Nominal Characteristic of Contact (stylus) Instruments (GB/T 6062-2009, ISO 3274:1996, IDT)
GB/T 9937 Dental Vocabulary (all parts) [ISO 1942 (all parts)]
GB/T 10610 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Rules and Procedures for the Assessment of Surface Texture (GB/T 10610- 2009, ISO 4288:1996, IDT)
YY/T 0967.1-2015 Dental Rotary Instruments - Shanks - Part 1: Shanks Made of Metals (ISO 1797-1:1992, MOD)
YY/T 1474 Medical Devices - Application of Risk Management to Medical Devices 6.1 Dimensions
The dimensions and tolerances of shanks shall comply with the requirements for Type- 1 shanks in YY/T 0967.1-2015. The shape and dimensions of Type-1 shanks and the head shall be specified by the manufacturer.
NOTE: Figure 1 ~ Figure 4 are examples.
The surface roughness shall comply with the requirements of YY/T 0967.1-2015. In accordance with the methods specified in GB/T 6062 and GB/T 10610, conduct the test.
Test shall be conducted in accordance with the method specified in 11.1 and 11.2. 6.2 Performance
The torque transmitter connected to a suitable dental handpiece shall be designed to transmit a torque of at least 0.8 N???m to the dental implant.
The shape and dimensions of the connecting part of the implant or its connecting parts and the torque transmitter shall at least be included in the label information. Test shall be conducted in accordance with the method specified in 11.3. NOTE: the measured value is a technical limit, instead of a medical description. The structure of the torque transmitter shall comply with the requirements of YY/T 1474 and provide safe and reliable operations in its connection with handpieces. 6.3 Material Selection
Applicable to Chapter 7 in YY/T 1486-2016.
The manufacturer of torque transmitter shall use materials designated in Appendix A in YY/T 1486-2016.
The hardness of steel rod pieces shall be tested by the method designated in GB/T 4340.1 and shall be not less than Vickers hardness 500HV5.
signs of performance degradation or corrosion.
The repetitive treatment cycle shall include recommended methods of cleaning, disinfection and sterilization.
10 Information Provided by the Manufacturer
Applicable to Chapter 11 in YY/T 1486-2016.
The shape and dimensions of the connecting part of the implant or its connecting parts and the torque transmitter shall at least be included in the label information. When appropriate, the manufacturer?€?s name or registered trademark shall be marked on the device or related auxiliary devices.
11 Test Methods
11.1 Inspection of Product Technical Documents
By checking the product?€?s technical documents, determine whether it complies with the requirements.
11.2 Dimensions
Conduct visual inspection and use suitable measuring instruments for the measurement, so as to determine whether the product complies with the requirements of all dimensions described by the manufacturer.
11.3 Stall Torque
11.3.1 Instruments
The requirements for the instruments are as follows:
a) Clamping system, which shall comply with YY/T 0967.1-2015.
b) Torque meter or dynamometer, which can measure torque in Newton meters, with an accuracy of ?? 10%.
11.3.2 Steps
Insert the torque transmitter into the clamping system, then, fix it. Connect the torque measuring device to the outer end of the torque transmitter. Slowly rotate the torque meter, until the maximum allowable torque is reached. No phenomenon of deformation shall be observed.

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