YY/T 1684-2020 English PDF

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YY/T 1684-2020: Dentistry--Apex locator
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1684-2020	129	Add to Cart	3 days	Dentistry--Apex locator	Valid

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Basic data

Standard ID: YY/T 1684-2020 (YY/T1684-2020)
Description (Translated English): Dentistry--Apex locator
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.20
Word Count Estimation: 7,798
Date of Issue: 2020-03-31
Date of Implementation: 2021-10-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements, test methods and instructions for apex locators. This standard applies to the apex locator used to confirm the position of the apical foramen by electrical measurement during root canal treatment.

YY/T 1684-2020: Dentistry--Apex locator

---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--Apex locator ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standard Dental apex locator 2020-03-31 released 2021-10-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain contents of this document may involve patents. Publication of this document The agency is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is organized by the National Dental Materials and Equipment Standardization Technical Committee Dental Equipment and Equipment Sub-Technical Committee (SAC/TC99 SC1) Centralized. Drafting organizations of this standard. Guangdong Medical Device Quality Supervision and Inspection Institute, Guilin Woodpecker Medical Devices Co., Ltd., Dentsply Tianjin) International Trade Co., Ltd. The main drafters of this standard. Lu Wenjuan, Lin Hongning, Wu Yiming, Fu Shi, Wang Yiwei, Xiao Chunyu. Dental apex locator

1 Scope

This standard specifies the requirements, test methods and instructions for apex locators. This standard applies to the apex locator that confirms the position of the apical hole by electrical measurement during root canal treatment.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Safety GB/T 9937 (all parts) oral vocabulary YY 0803.1-2010 Dental root canal instruments Part 1.General requirements and test methods

3 Terms and definitions

The following terms and definitions defined in GB 9706.1 and GB/T 9937 apply to this document. 3.1 Tooth apex locator In the process of root canal treatment, a device to confirm the position of the apical hole by electrical measurement. 3.2 Electrode wire One end is connected with the host of the locator, and the other end is a wire connected with the lip hook and the root canal file clamp. 3.3 Lip hook A conductive component placed on the patient’s lip when locating the apical hole. 3.4 Root Canal File Clip Fixing devices such as root canal files and enlargement needles are also used as conductive parts to ensure that current can flow through the root canal file and enlargement in the root canal when the root canal is positioned. Measuring instruments such as large needles. 3.5 Apical hole The opening of the root canal at the apex of the tooth is the main channel for the connection between the pulp and the periapical tissue and the whole body. The blood vessels, nerves, and lymph vessels of the dental pulp This enters the medullary cavity.

4 requirements

4.1 Appearance and structure The appearance and structure are as follows. a) The outer surface of the locator should be flat, smooth, and tidy, and there should be no obvious bumps, cracks, or sharp edges. The outline of the transition should be clear. There are obvious scratches. b) The control parts and sockets of the locator should be installed correctly and firmly, and their functions should meet the marked functions. c) The locator switch and control buttons/knobs should be flexible and reliable in operation, and the fasteners should not be loose. d) The characters and marks of the locator should be clear, accurate and firm. Perform visual inspection according to 6.1. 4.2 Positioning accuracy When using the device shown in 6.2 to locate the apical hole, the difference between the positioning position and the actual position should be within ±0.5mm. Test according to 6.2 method. 4.3 Identification of the apical hole When the device detects the apical hole, it should be able to give visual and auditory reminders. Test according to the method of 6.3. 4.4 Sterilization resistance of the lip hook Reusable lip hooks, according to the sterilization steps recommended by the manufacturer, unless otherwise specified by the manufacturer, the lip hooks should at least withstand 250 cycles of processing without performance degradation. The test should be carried out in accordance with the manufacturer's instructions or other technical documents. After the test, it shall meet the requirements of 4.2 and 4.3. 4.5 Corrosion resistance of lip hook The lip hook should be corrosion resistant, that is, after the material is sterilized as specified in 4.4, there should be no visible corrosion. Perform visual inspection according to 6.1. 4.6 Safety requirements Should meet the requirements of GB 9706.1.

5 sampling

All type tests shall be carried out on a representative model of the locator.

6 Test method

6.1 Visual inspection Direct visual inspection without magnification. 6.2 Positioning accuracy test 6.2.1 Measuring device 6.2.1.1 The equivalent model of isolated teeth should have a root canal channel, see Appendix A. 6.2.1.2 K-type standard root canal file, in line with YY 0803.1, stainless steel material, nominal size 015. 6.2.1.3 0.9% normal saline. 6.2.1.4 Fixing frame, as shown in Figure 1 for fixing the equivalent model of the isolated tooth. Figure 1 Test system for positioning accuracy 6.2.2 Test procedure a) As shown in Figure 1, arrange the test system. b) Slowly insert the K-shaped root canal file into the equivalent model of the isolated tooth until the locator prompts to reach the apical hole, and observe the tip of the K-shaped root canal file Whether the tip is within ±0.5mm of the actual apical hole. 6.3 Identification test of apical hole Using the test system of 6.2, when the locator detects the apex hole, check the prompt function of the locator. 6.4 Safety requirements Test according to the requirements of GB 9706.1.

7 Manual

The instructions should meet the requirements of GB 9706.1.In addition, the manufacturer should provide the following information. a) Working environment (including at least humidity and temperature); b) The positioning accuracy of the locator; c) If applicable, the sterilization method of the lip hook, and a description of whether the root canal file holder and electrode wire can be sterilized; d) If applicable, instructions for single use of lip hook and root canal file holder.

Appendix A

(Normative appendix) Equivalent model of isolated teeth The equivalent model of isolated teeth can be made of polyethylene resin or other non-conductive materials. As shown in Figure A.1, the height of the equivalent model of the isolated tooth should be 16mm~20mm. Root canal outlet (simulated apical hole) diameter It should be 0.15mm±0.02mm. The bottom outlet should be cylindrical, with a diameter of 3.5mm±0.2mm, and a height of 1mm~2mm. The shape of the root canal channel can be designed according to the standard root canal instrument with the nominal specification of 015 (see 5.1 in YY 0803.1-2010). Root canal The exit of the canal (simulated apical hole) is the reference 0mm, and the scale is marked with 0.5mm and -0.5mm. The overall external shape of the equivalent model of isolated teeth is specified by the manufacturer, which can be rectangular or cylindrical. The height should be 16mm~ 20mm. The bottom in Figure A.1 is an example, it is a square with a side length of 10mm~12mm. Unit is mm Figure A.1 Equivalent model of isolated teeth ......

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