YY/T 1043.1-2022 English PDF

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YY/T 1043.1-2022: Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
Status: Valid

YY/T 1043.1: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1043.1-2022	399	Add to Cart	4 days	Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements	Valid
YY/T 1043.1-2016	519	Add to Cart	3 days	Dentistry--Dental units--Part 1: General requirements and test methods	Obsolete
YY/T 1043-2004	559	Add to Cart	3 days	Dental units	Obsolete

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YY 1042   YY/T 0823   YY/T 0824   YY 1045   YY/T 1043.2   

Basic data

Standard ID: YY/T 1043.1-2022 (YY/T1043.1-2022)
Description (Translated English): Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Word Count Estimation: 18,116
Date of Issue: 2022-10-17
Date of Implementation: 2024-04-01
Older Standard (superseded by this standard): YY/T 0058-2015; YY/T 1043.1-2016
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements and test methods for non-mobile dental units, dental patient chairs, and combinations of the two, whether or not they are powered. This standard also specifies the requirements for instructions for use, technical instructions, marking and packaging. This standard does not apply to physician chairs, portable dental equipment and dental lights.

YY/T 1043.1-2016: Dentistry--Dental units--Part 1: General requirements and test methods

---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 units - Part 1. General requirements and test methods ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 1043-2004 Dental Dental Treatment Machine Part 1. General requirements and test methods (ISO 7494-1..2011, MOD) 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Category 4 5 request 2 6 sampling 5 7 Test 5 8 Manufacturer's instructions 6 Mark 7 10 Packaging 7 Appendix A (informative appendix) Differences and reasons for this chapter and ISO 7494-1..2011 8 Reference 9

Foreword

YY 1043 "dental dental treatment machine" is divided into two parts. - Part 1. General requirements and test methods; Part 2. Water supply and gas supply. This part is part 1 of YY 1043. YY/T 0630-2008 (ISO 7494-2..2003, IDT) is part 2 of YY 1043 and is subsequently revised. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY/T 1043-2004 "dental treatment machine". This section is the main change compared with YY/T 1043-2004 as follows. --- increased the definition and requirements of dental devices and high frequency surgical devices; - increased biocompatibility requirements; --- Increased requirements for the connection of the piping lines; - the need to remove the pressure release; --- updated the technical description and logo requirements; --- Removal of normative Appendix A, test sequence; --- Added information on the differences between Appendix A, this part and ISO 7494-1..2011 Chapter number differences and reasons. This section is modified using ISO 7494-1..2011 "Dental Dental Therapy Machine Part 1. General Requirements and Test Methods" (English Version). The main technical differences between this part and ISO 7494-1..2011 are as follows. --- According to the current domestic medical equipment safety requirements of the implementation of the situation, with GB 9706.1-2007 (IEC 60601-1. 1988 A1..1991 A2..1995, IDT) Replace IEC 60601-1..2005; Similarly, remove IEC 80601-2-60 "Medical electrical equipment Part 2-60. Particular requirements for basic safety and basic performance of dental equipment ", IEC 62366" Medical device availability Procedures in the application of medical devices "and 5.1.4 usability; 5.1.2, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6 were followed by YY/T 1043-2004 "dental treatment machine" 5.1.2, 5.3.2, 5.3.10, 5.3.12.2, 5.3.13.2, 5.3.17, 7.3.2, 7.3.3 are followed by YY/T 1043-2004 Section of the treatment machine "7.3.3,7.3.4 test method; - For international standards cited in this section, if converted to our standard, this section will replace the international standard number referenced The corresponding country or industry standard number, and indicate the use of the relationship in Chapter 2; --- Added information on the differences between Appendix A, this part and ISO 7494-1..2011 Chapter number differences and reasons. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This part of the National Dental Material and Equipment Standardization Technical Committee of Dental Equipment and Instruments Subcommittee (SAC/TC99 SC1). This part of the drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Xianyang Northwest Medical Devices (Group) Co., Ltd., Foshan City Shengtian Medical Devices Co., Ltd., Ningbo Lan Ye Medical Equipment Co., Ltd., Taishan City Fu Ken scientific research industry Limited company. This part of the main drafters. Wu Yiming, Li Wei, Zhao Lijun, Li Danrong, Yang Qi, Peng Bo, Lei Kangning. This part was first published in 1965, the second revision in 1989, the third revision in.2004, this time for the fourth revision.

Introduction

This section does not contain qualitative and quantitative test methods for biological hazards, but is recommended when assessing possible biological hazards GB/T 16886.1. Dental Dental Treatment Machine Part 1. General requirements and test methods

1 Scope

This part of YY/T 1043 specifies the requirements and test methods of the dental treatment machine, whether or not it is driven by electricity. This part also specifies the manufacturer's instructions, labeling and packaging requirements.

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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB/T 9937 Oral vocabulary (all parts) [ISO 1942 (all parts), IDT] YY 0058-2015 Dental patient chair (ISO 6875..2011, MOD) Graphical symbols for dental equipment (ISO 9687..1993, IDT) YY/T 0628-2008 Access to Drainage Pipes for Dental Equipment (ISO 11144..1995, IDT) YY/T 0841-2011 Medical electrical equipment Medical electrical equipment Periodic testing and post-repair testing (IEC 62353..1997, IDT) YY/T 1285-2015 Dental Oral Health Care Personnel Dental Equipment Location Information System (ISO 4073. 2009, IDT) ISO 21530..2004 Dentistry-Materialsused Dental Materials Surface Materials Chemical Densitizers (Dentistry-Materialsused fordentalequipmentsurfaces-Determination ofresistancetochemicaldisinfectants)

3 terms and definitions

GB/T 9937, GB 9706.1-2007 and YY/T 1285-2015 and the following terms and definitions apply to this document. 3.1 Dental equipment dentalequipment Facilities, machines, instruments and accessories for dental treatment and/or related procedures. 3.2 Dental treatment machine dentalunit An interconnected dental device and apparatus constitute a functional combination of equipment for dental treatment. 3.3 Dental phone dentalhandpiece Hand-held instruments connected to dental treatment machines for oral treatment. 3.4 High frequency surgical device highfrequencysurgerydevice/HFsurgerydevice A hand-held medical electrical device for cutting or repairing biological tissue and transmitting high frequency current during a surgical procedure. ......

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