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YY/T 1485-2016: Dentistry--Dental implant unit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1485-2016 | English | 139 |
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Dentistry--Dental implant unit
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YY/T 1485-2016
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Basic data | Standard ID | YY/T 1485-2016 (YY/T1485-2016) | | Description (Translated English) | Dentistry--Dental implant unit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 7,729 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB 4208-2008; GB 9706.1; YY/T 0628-2008; YY 1012-2004; YY 1045.2; YY 1057-2016; YY/T 1400-2016; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements of 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 implant treatment. This standard does not cover the requirements of mobile phones used for implantation. | YY/T 1485-2016: Dentistry--Dental implant 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 - Dental implant unit
ICS 11.060.20
C33
People's Republic of China Pharmaceutical Industry Standard
Dental Dental Implant
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is 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. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Dental Materials and Equipment Standardization Technical Committee of Dental Equipment and Instruments Subcommittee (SAC/TC99
SC1).
The drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Ningbo Lan Ye medical equipment
Limited, Xianyang Northwest Medical Devices (Group) Co., Ltd., Guilin Woodpecker Medical Devices Co., Ltd.
The main drafters of this standard. Lu Wenjuan, Zhao Lijun, Yang Qi, Du Xiao Shu.
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.
Any equipment parts recommended by the manufacturer for use with dental implants shall not cause equipment to be unsafe.
All tests specified in this standard are type tests.
Dental Dental Implant
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 article
Pieces. 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.
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