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YY/T 1602-2018Dentistry—Root canal preparation unit (English PDF)

牙科学根管预备机

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 19, 2018

Implementation date

January 1, 2019

Scope

YY/T 1602-2018 is the English-translated version of 牙科学根管预备机.

YY/T 1602-2018 is the Chinese pharmaceutical industry standard for the root canal preparation unit, the endodontic motor that drives files in the canal.

It sets the requirements, the test methods and the instructions, covering the speed and the torque and their accuracy and the torque limiting function, the reverse and auto-stop behaviour, the handpiece and the file chuck, the noise, the cleaning and sterilization of the parts that enter the mouth and the electrical safety. Issued on 19 January 2018, it has applied since 1 January 2019.

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Document preview — YY/T 1602-2018

National Standard of the People's Republic of China

ICS: 11.060.20
Classification: C 33

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0803.4-2015|YY 0717-2023|YY 0803.3-2016|YY 0803.1-2010|YY/T 1411-2023|YY/T 0268-2008

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