YY/T 1692-2020 English PDF (YYT1692-2020)

This Standard specifies the terms and definitions, requirements, test methods and the requirements for instructions of hot melt gutta percha filling machine. This Standard is applicable to hot melt gutta percha filling machines, which complete root canal filling by heating and melting gutta percha. This Standard is not applicable to equipment and instruments used merely for cutting off gutta percha.

YY/T 1692-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.20
C 33
Dentistry - Hot Melt Gutta Percha Filling Machine
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JUNE 1, 2021
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Requirements... 6
5 Test Methods ... 9
6 Instructions for Use ... 12
Appendix A (informative) Schematic Maps of Injecting and Backfilling
Instrument and Heating and Packing Instrument ... 13
Dentistry - Hot Melt Gutta Percha Filling Machine
1 Scope
This Standard specifies the terms and definitions, requirements, test methods and the requirements for instructions of hot melt gutta percha filling machine. This Standard is applicable to hot melt gutta percha filling machines, which complete root canal filling by heating and melting gutta percha (hereinafter referred to as filling machines).
This Standard is not applicable to equipment and instruments used merely for cutting off gutta percha.
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 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
GB/T 9937.3 Dental Vocabulary - Part 3: Dental Instruments
YY/T 0149 Medical Instruments of Stainless Steel - Test Methods of Corrosion Resistance
YY 0505 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility - Requirements and Tests 3 Terms and Definitions
What is defined in GB 9706.1 and GB/T 9937.3, and the following terms and definitions are applicable to this document.
3.1 Hot Melt Gutta Percha Filling Machine
Hot melt gutta percha filling machine refers to an instrument that completes root canal filling by heating and melting gutta percha and injecting it into the root canal in root canal treatment. It is usually composed of an injecting and backfilling instrument or a 3.9 Work Tip Thermal Sleeve
Work tip thermal sleeve refers to a component that is installed on the bending section of the work tip to block high temperature and prevent from burning the patient’s oral cavity.
4 Requirements
4.1 Appearance
In accordance with the method described in 5.2, conduct the test. The appearance of the injecting and backfilling instrument shall satisfy the following requirements: a) The appearance of the injecting and backfilling instrument shall be easy to clean; the shell shall manifest no sharp edges, burrs or cracks; the plastic parts shall be free of blistering, cracking or deformation;
b) The panel of the injecting and backfilling instrument shall manifest no peeling or rusting of the coating; the text and marking on the panel shall be clearly visible.
4.2 Injecting and Backfilling Instrument (if possible)
4.2.1 Heating function of handpiece of injecting and backfilling instrument The heating function of handpiece of injecting and backfilling instrument shall satisfy the following requirements:
a) In accordance with the method described in 5.3.1 a), conduct the test; the manufacturer shall specify the adjustment range and adjustment mode of the heating temperature of the handpiece of the injecting and backfilling
instrument;
b) In accordance with the method described in 5.3.1 b), conduct the test; the heating temperature control deviation of the handpiece of the injecting and backfilling instrument shall not exceed ± 10%;
c) In accordance with the method described in 5.3.1 c), conduct the test; the injecting and backfilling instrument shall have an independent timer to control the continuous heating time; when the timer limit is reached, the handpiece of the injecting and backfilling instrument shall automatically stop heating; d) In accordance with the method described in 5.3.1 d), conduct the test; the handpiece of the injecting and backfilling instrument shall have an obvious indication for two working states: heating process and temperature reaching the preset value.
b) In accordance with the method described in 5.4.2 b), conduct the test. During the normal use, the surface temperature of the bending section of the work tip shall be not higher than 51 °C, or, the surface temperature of the work tip thermal sleeve (if possible) shall be not higher than 60 °C.
4.4 Toughness
The toughness of gutta percha injecting needle and work tip shall satisfy the following requirements:
a) In accordance with the method described in 5.5 a), conduct the test; after receiving the toughness test, the gutta percha injecting needle (if possible) shall manifest no phenomenon of fracture;
b) In accordance wit the method described in 5.5 b), unless the manufacturer specifies that the work tip (if possible) cannot be bended, otherwise, after receiving the toughness test, the work tip shall manifest no phenomenon of fracture. In addition, after being connected to the handpiece of the heating and packing instrument, it shall be able to normally heat up.
4.5 Surface Roughness
In accordance with the method described in 5.6, conduct the test; the surface roughness Ra of the work tip (if possible) shall be not greater than 0.8 μm. 4.6 Corrosion Resistance and Anti-sterilization
The corrosion resistance and anti-sterilization of the components of the filling machine shall satisfy the following requirements:
a) In accordance with the method described in 5.7 a), conduct the test; the work tip (if possible) shall have good corrosion resistance; there shall be no visible signs of corrosion;
b) In accordance with the method described in 5.7 b), conduct the test; when (if possible) gutta percha injecting needle, thermal protector cap, work tip and work tip thermal sleeve are for single use, then, before exiting factory, the single-use components shall be sterilized, or, be sterilized before use in accordance with the sterilization steps specified by the manufacturer in the accompanying documents, and there shall be no phenomenon of damage.
When (if possible) gutta percha injecting needle, thermal protector cap, work tip and work tip thermal sleeve are reusable, then, the reusable components shall at least be able to endure the number of sterilization specified by the manufacturer in accordance with the sterilization steps specified by the manufacturer in the accompanying documents without manifesting any
phenomenon of damage.
heating chamber specified by the manufacturer;
c) Conduct structural inspection and actual operation inspection; use a stopwatch for timing;
d) Conduct visual observation and actual operation in the inspection.
5.3.2 Gutta percha injecting needle installation test
Conduct actual operation in the inspection; use a dynamometer to axially pull the gutta percha injecting needle.
5.3.3 Thermal protector cap surface temperature test
Set the heating temperature of the handpiece of the injecting and backfilling instrument to the highest gear of the temperature control range. In accordance with the longest loading time in the working mode specified by the manufacturer, heat it up; use a thermometer to measure the surface temperature of the thermal protector cap. 5.4 Heating and Packing Instrument Test
5.4.1 Heating function test of handpiece of heating and packing instrument The heating function test of the handpiece of the heating and packing instrument shall be conducted in accordance with the following methods:
a) Conduct actual operation in the inspection;
b) In accordance with the stipulations of accompanying documents, set the heating temperature of the handpiece of the heating and packing instrument respectively to three gears (high, medium and low) of the temperature control range (if the number of heating temperature adjustment gears is less than 3, then, respectively set each heating temperature gear); properly install the work tip and actuate heating. Use a contact thermometer with a response time lower than the handpiece heating time and an accuracy superior to the
nominal accuracy of the handpiece to measure the maximum temperature of the tip of the work tip;
c) Conduct structural inspection and actual operation inspection; use a stopwatch for timing;
d) Conduct structural inspection and actual operation inspection;
e) Conduct visual observation and actual operation in the inspection.
5.4.2 Work tip test
Conduct the work tip test in accordance with the following methods:
6 Instructions for Use
The instructions for use shall comply with the requirements of GB 9706.1. In addition, the manufacturer shall also provide the following information:
a) The name, address and contact information of the manufacturer;
b) Product name and model of filling machine;
c) Product composition, accessories and tools of filling machine;
d) Working conditions and power supply rating (voltage and frequency);
e) Heating range and accuracy, and continuous heating time of automatic stop of the handpiece of the injecting and backfilling instrument (if possible); f) Heating range and accuracy, highest heating temperature and continuous heating time of automatic stop of the handpiece of the heating and packing instrument (if possible);
g) The operation mode, the continuous rate and maximum loading time of the handpiece of the injecting and backfilling instrument (if possible), and the handpiece of the heating and packing instrument (if possible);
h) In terms of (if possible) gutta percha injecting needle, work tip, thermal protector cap or work tip thermal sleeve, the sterilization method and
sterilization frequency of the component;
i) The specifications and dimensions of gutta percha injecting needle (if possible) and work tip (if possible);
j) Whether the work tip (if possible) can be bended and the bendable angle.