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YY/T 1485-2016Dentistry—Dental implant unit (English PDF)

牙科学牙科种植机

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1485-2016 is the English-translated version of 牙科学牙科种植机.

YY/T 1485-2016 is the Chinese pharmaceutical industry standard for the dental implant unit, the motor and control unit used with a handpiece to prepare the site and place a dental implant.

It specifies the requirements, the test methods and the instructions for use, covering the speed and the torque delivered and their accuracy, the reduction handpiece and the coupling, the irrigation of the site, the programmes and the display, the sterilization of the parts that are sterilized and the electrical safety. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1485-2016

National Standard of the People's Republic of China

Classification: C 33

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

Foreword
Introduction
1 Scope
2 Normative reference documents
3 Terms and definitions
4 Requirements

Foreword

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

Introduction

The dental implants specified in this standard are intended to provide a source of power for mobile phones used for implant treatment.

The dental implants specified in this standard may be used in conjunction with mobile phones.

1 Scope

This standard specifies the requirements for dental implants, test methods and instructions.

This standard applies to dental implants (as defined in 3.1). The dental implants are used in conjunction with mobile phones for dental implantation for dental implantation treatment.

This standard does not cover the requirements of mobile phones used for implant treatment.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB 4208-2008 enclosure protection class (IP code) (IEC 60529.:2001, IDT)

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)] Graphical symbols for dental equipment (ISO 9687.:1993, IDT) YY/T 0628-2008

YY 1012-2004 Dental phone coupling size (ISO 3964. 1982, IDT)

YY 1045.2 Dental handsets Part 2. Straight phones and curved handsets (YY 1045.2-2010, ISO 7785-2.:1995, IDT) General technical conditions for medical foot switch YY 1057-2016

YY/T 1400-2016 Dentistry Dental equipment Surface materials - Determination of chemical disinfectants (ISO 21530.:2004, IDT)

3 Terms and definitions

GB 9706.1, GB/T 9937 Definitions and the following terms and definitions apply to this document.

3.1 Dental implant machine

dentalimplantunit A device that provides driving force for mobile phones used for implantation therapy, consisting of at least a host, a planter motor, and a foot switch.

4 Requirements

4.1 Operation control device

4.1.1 Overview

The operation control device should be designed and positioned to prevent its accident from starting.

Operation control devices and graphic symbols indicating performance shall comply with the requirements of YY/T 0628-2008.

4.1.2 Speed

The dental plant should have a speed setting function.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

GB 4208-2008

Similar standards

YY/T 1064-2022|YY/T 1486-2016|YY/T 1411-2023|YY/T 0127.4-2023|YY 0304-2023|YY 0315-2023

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