YY/T 1755-2021 English PDF

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YY/T 1755-2021: Dentistry - Powder jet handpieces and powders
Status: Valid

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Basic data

Standard ID: YY/T 1755-2021 (YY/T1755-2021)
Description (Translated English): Dentistry - Powder jet handpieces and powders
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Word Count Estimation: 14,160
Issuing agency(ies): State Drug Administration

YY/T 1755-2021: Dentistry - Powder jet handpieces and powders

---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 - Powder jet handpieces and powders ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standards Dental blasting handpiece and sandblasting powder (ISO 20608.2018,MOD) Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Table of contents

Foreword Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Mobile phone classification 3 5 Requirements 3 6 Sampling 6 7 Measurement and test methods 6 8 Instructions for use, maintenance and service 8 9 Technical Specification 9 10 Signs and labels 9 11 Packaging 10

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafting method to amend and adopt ISO 20608.2018 "Dental Blasting Handpieces and Blasting Powder". The main technical differences between this standard and ISO 20608.2018 are as follows. ---Regarding normative reference documents, this standard has made different adjustments to adapt to my country's technical conditions and adjustments. Reflected in Chapter 2 "Regulatory Application Documents", the specific adjustments are as follows. ● Replace ISO 1942 with GB/T 9937 modified to adopt international standards (see Chapter 3); ● Replace IEC 62366-1 with YY/T 1474 equivalent to the international standard (see 5.1, 5.2, 5.8, 5.9); ● Replace ISO 14971 with YY/T 0316 equivalent to the international standard (see 5.1, 5.2); ● Replace ISO 10993-1 with GB/T 16886.1 equivalent to the international standard (see 5.1, 5.2); ● Replace IEC 60601-1.2005 AMD1.2012 (see 5.2, 5.7, 5.8, 5.12); ● Replace ISO 7494-1 (see 3.2, 5.3, 5.11, 8.1) with YY/T 1043.1 which is modified to adopt international standards; ● Replace IEC 80601-2-60.2012 (see 5.5, 5.12, 7.8, 7.9); ● Replace ISO 9687 with YY/T 0628 which is equivalent to the international standard (see 5.8, 10.1); ● Replace ISO 9168 (see 5.10, 5.11, 7.6) with YY/T 0514 modified to adopt international standards; ● Replace IEC 61672-1 (see 7.7) with GB/T 3785.1 which is equivalent to adopting international standards; ● Replace ISO 17664 with YY/T 0802 modified to adopt international standards (see 8.1); ● Use GB/T 16483 instead of ISO 11014 (see 8.2, 9.2, 10.3); ● Replace ISO 15223-1 with YY/T 0466.1 equivalent to the international standard (see 10.1); ● Replace ISO 21531 with YY/T 1501 equivalent to the international standard (see 10.1); ● Delete the international standards ISO 5349.1 and ISO 5349.2. ---Delete 5.6 "vibration" of ISO 20608.2018, which has been stipulated in GB 9706.1. --- Delete the 5.14 "test report" of ISO 20608.2018 to adapt to the specific domestic situation. This standard also made the following editorial changes. --- Delete the "Foreword" of ISO 20608.2018. ---Delete the introductory words about the website of IEC and ISO terminology database in the terms and definitions of ISO 20608.2018. ---Delete Appendix A "Example of Test Report" of ISO 20608.2018. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is organized by the National Dental Materials and Equipment Standardization Technical Committee Dental Equipment and Equipment Sub-Technical Committee (SAC/ TC99/SC1) Centralized. Drafting organizations of this standard. Guangdong Medical Device Quality Supervision and Inspection Institute, Kava Shengbang (Shanghai) Dental Medical Devices Co., Ltd., Yimai Sri Lanka Electronic Medical System Trading (Shanghai) Co., Ltd. The main drafters of this standard. Wu Weirong, Lin Hongning, Zhang Yang, Wu Yiming, Li Junfang, Kong Yuan.

Introduction

Sandblasting handpieces have been used in the dental field for many years. Technological development continues to create better and easier-to-operate sandblasting mobile phones and the sandblasting powder used. For example, for cleaning teeth, for To obtain a good clinical effect, the correct combination of these elements is extremely important. Dental blasting handpiece and sandblasting powder

1 Scope

This standard specifies the general requirements, test methods, manufacturer's information, signs and packaging for sandblasting mobile phones. This independently designed sandblasting hand The machine is shown in Figure 1. This standard applies to sandblasting handpieces and sandblasting powders in the dental field. They can be used to remove patients' tartar, stains and dental plaque. Used for cleaning When cleaning and polishing teeth, abrasion is a side effect. This standard is also applicable to sandblasting handpieces and sandblasting powders that use air-driven abrasion in the dental field, such as the preparation of minimally invasive cavities, adhesion The surface treatment and the removal of the cement before the mixture is used. In this case, abrasion is part of the expected result. This standard does not apply to dental units that provide power for sandblasting handpieces. This standard does not apply to dental polishing handpieces (contra-angle handpieces), or electric plaque cleaners (scaler) or multi-function handpieces (spray guns).

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 3785.1 Electroacoustic Sound Level Meter Part 1.Specifications (GB/T 3785.1-2010, IEC 61672-1.2002, IDT) GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1. 2012, MOD) GB 9706.260-2020 Medical electrical equipment Part 2-60.Specific requirements for basic safety and basic performance of dental equipment (IEC 80601-2-60.2012,MOD) GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD) GB/T 16483 Chemical safety technical specification content and item sequence GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (GB/T 16886.1- 2011, ISO 10993-1.2009, IDT) YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction Version, IDT) YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements (YY/T 0466.1-2016,ISO 15223-1.2012,IDT) YY/T 0514 Dental hose connector for pneumatic dental handpiece (YY/T 0514-2018, ISO 9168.2009, MOD) YY/T 0628 Graphical symbols for dentistry dental equipment (YY/T 0628-2020, ISO 9687.2015 A1.2018, IDT) YY/T 0802 Handling of medical devices Information provided by medical device manufacturers (YY/T 0802-2020, ISO 17664. 2017, MOD) YY/T 1043.1 Dental treatment machine Part 1.General requirements and test methods (YY/T 1043.1-2016, ISO 7494-1.2011, MOD) YY/T 1474 Application of medical device usability engineering to medical devices (YY/T 1474-2016, IEC 62366.2007, IDT) YY/T 1501 Graphical symbols for dental instruments (YY/T 1501-2016, ISO 21531.2009, IDT) ......

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