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YY/T 1602-2018 English PDF

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YY/T 1602-2018: Dentistry--Root canal preparation unit
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1602-2018139 Add to Cart 3 days Dentistry--Root canal preparation unit Valid

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Basic data

Standard ID: YY/T 1602-2018 (YY/T1602-2018)
Description (Translated English): Dentistry--Root canal preparation unit
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.20
Word Count Estimation: 7,719
Date of Issue: 2018-01-19
Date of Implementation: 2019-01-01
Quoted Standard: GB 9706.1; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; YY/T 0628; YY 1012; YY 1045.2; YY 1057-2016; YY/T 1400-2016
Regulation (derived from): China Food and Drug Administration announced No. 8 of 2018
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements, test methods, and instructions for the root canal preparation machine. This standard applies to the root canal preparation machine (hereinafter referred to as the preparation machine).

YY/T 1602-2018: Dentistry--Root canal preparation unit

---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.Root canal preparation unit ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standard Dentistry root canal preparation machine Published on.2018-01-19 2019-01-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. Publication of this document The organization is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is divided into the National Technical Committee for Dental Materials and Equipment Standardization Technical Committee of Dental Equipment and Devices (SAC/TC99). SC1). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Guilin Woodpecker Medical Devices Co., Ltd., Ningbo Lanye Medical Equipment Co., Ltd. The main drafters of this standard. Lu Wenjuan, Liu Sisheng, Yan Lin, Du Xiaotong, Xu Buguang, Xu Wen. Dentistry root canal preparation machine

1 Scope

This standard specifies the requirements, test methods and instructions for the root canal preparation machine. This standard applies to the root canal preparation machine (hereinafter referred to as the preparatory machine).

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1.1988, IDT) GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)] YY/T 0628 dental equipment graphic symbol (YY/T 0628-2008, ISO 9687.1993, IDT) YY 1012 dental handpiece coupling size (YY 1012-2004, ISO 3964.1982, IDT) YY 1045.2 Dental handpieces Part 2. Straight and contra-angle handpieces (YY 1045.2-2010, ISO 7785-2.1995, MOD) YY 1057-2016 General technical conditions for medical foot switches YY/T 1400-2016 Determination of surface chemical resistance to chemical disinfectants in dental equipment (ISO 21530.2004, IDT)

3 Terms and definitions

The following terms and definitions as defined in GB 9706.1 and GB/T 9937 apply to this document. 3.1 Root canal preparation machine rootcanalpreparationunit It is usually composed of a control part, a motor, a mobile phone, and is used for root canal treatment and root canal preparation and root canal preparation and cleaning equipment.

4 requirements

4.1 Appearance and structure 4.1.1 The outer surface of the preparatory machine should be smooth, smooth and tidy. There should be no obvious bumps, cracks or sharp edges. The contour of the transition should be clear and there should be no Obvious scratches. 4.1.2 The control parts and sockets of the preparatory machine shall be installed correctly and firmly, and their functions shall comply with the marked functions. 4.1.3 The standby switch and control button/knob operation should be flexible and reliable, and the fasteners should be free from looseness. 4.1.4 The text and marking of the preparatory machine should be clear, accurate and firm. 4.2 indication function 4.2.1 If the battery is powered, it should be able to display the battery level and should prompt when the battery is low. 4.2.2 should be able to indicate speed, torque and motor steering. If it can be used with two or more speed ratio mobile phones, the speed ratio should be indicated.
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