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YY/T 0629-2021 English PDF

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YY/T 0629-2021: Dentistry - Central suction source equipment
Status: Valid

YY/T 0629: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0629-2021English319 Add to Cart 4 days [Need to translate] Dentistry - Central suction source equipment Valid YY/T 0629-2021
YY/T 0629-2008English639 Add to Cart 3 days [Need to translate] Dental equipment. High-and medium-volume suction systems Obsolete YY/T 0629-2008

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Basic data

Standard ID YY/T 0629-2021 (YY/T0629-2021)
Description (Translated English) Dentistry - Central suction source equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Word Count Estimation 17,139
Issuing agency(ies) State Drug Administration

YY/T 0629-2021: Dentistry - Central suction source equipment

---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 - Central suction source equipment ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standards Replace YY/T 0629-2008, YY/T 0905.1-2016 Central suction source equipment for dentistry (ISO 10637.2018, MOD) Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Table of contents

Foreword Ⅰ Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Category 3 5 Requirements 3 6 Sampling 4 7 Test method 4 8 Manufacturer Information 6 9 Mark 7 10 Packaging 7 Appendix A (informative appendix) Suction system type 8 Appendix B (informative appendix) Source equipment of dry suction system Figure 9 Appendix C (informative appendix) Source equipment of semi-dry suction system Figure 10 Appendix D (informative appendix) Source equipment of wet suction system Figure 11 Reference 12

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0629-2008 "High-volume and medium-volume suction system for dental equipment" and YY/T 0905.1-2016 "Dental Scientific field equipment part 1.Attraction system. The main differences between this standard and YY/T 0629-2008 are as follows. ---Modified the content of the scope (see Chapter 1, Chapter 1 of the.2008 edition); ---Modified the normative reference documents (see Chapter 2, Chapter 2 of the.2008 edition); ---Modified terms and definitions (see Chapter 3, Chapter 3 of the.2008 edition); ---Modified the classification (see Chapter 4, Chapter 4 of the.2008 edition); ---Added the characteristic description of the flow performance of the central suction source equipment (see 5.1); ---Modified the maximum suction pressure (see 5.2, 5.3 of the.2008 edition); ---Modified the safety requirements (see 5.3, 5.8 in the.2008 edition); ---Added electromagnetic compatibility (EMC) requirements (see 5.4); ---Added the requirements for amalgam separators (see 5.5.1); ---Added the requirements for the bacterial filter (see 5.5.2); --- Modify the requirements of manufacturer information (see Chapter 8, Chapter 8 of the.2008 edition); --- Modified the marking requirements (see Chapter 9, Chapter 9 of the.2008 edition); ---Added informative appendices A, B, C, D ((see appendix A, B, C, D); ---Added references; --- Deleted the general provisions (see 5.1 of the.2008 edition); --- Deleted the general requirements (see 5.2 in the.2008 edition); --- Deleted the air separator requirements (see 5.4 in the.2008 edition); --- Deleted the attachment requirements (see 5.5 in the.2008 edition); --- Deleted the noise level requirements (see 5.6 in the.2008 edition); --- Deleted the waste disposal requirements (see 5.7 in the.2008 edition); --- Deleted the original informative Appendix A ((see Appendix A of the.2008 edition). The main differences between this standard and YY/T 0905.1-2016 are as follows. ---Modified the content of the scope (see Chapter 1, Chapter 1 of the.2016 edition); ---Modified the normative reference documents (see Chapter 2, Chapter 2 of the.2016 edition); ---Modified terms and definitions (see Chapter 3, Chapter 3 of the.2016 edition); ---Modified the classification (see Chapter 4, Chapter 4 of the.2016 edition); ---Added the characteristic description of the flow performance of the central suction source equipment (see 5.1); ---Modified the maximum suction pressure (see 5.2, 5.2.2 of the.2016 edition); ---Modified the safety requirements (see 5.3, 5.2.21 of the.2016 edition); ---Added electromagnetic compatibility (EMC) requirements (see 5.4); ---Modified the requirements of the bacterial filter (see 5.5.2, 5.2.19 of the.2016 edition); --- Modify the requirements for manufacturer information (see Chapter 8, Chapter 8 of the.2016 edition); --- Modified the marking requirements (see Chapter 9, Chapter 9 of the.2016 edition); ---Modified the order of 4 informative appendices A, B, C, D (see appendix A, B, C, D); --- Deleted the overview (see 5.1 of the.2016 edition); --- Deleted general requirements (except for maximum suction pressure, bacterial filter, electrical safety requirements) (see 5.2 in the.2016 edition); --- Deleted performance (see 5.3 of the.2016 version); --- Deleted cleaning and disinfection (see 5.4 in the.2016 edition); --- Deleted the position of the attracting machine (see 5.5 in the.2016 edition); ---The exhaust system has been deleted (see 5.6 in the.2016 edition). This standard uses the redrafting method to modify and adopt ISO 10637.2018 "Dental Central Suction Source Equipment" (English version). The main technical differences between this standard and ISO 10637.2018 are as follows. ---Regarding normative reference documents, this standard has been adjusted to adapt to my country's technical conditions and facilitate the implementation of this standard. The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows. ● Added GB 9706.1 and YY 9706.102 (see Chapter 2); ● Replace ISO 1942 with the modified GB/T 9937 (see Chapter 3); ● Replace ISO 7494-2 with YY/T 1043.2 which is equivalent to the international standard (see Chapter 3); ● Replace IEC 60335-1 with GB 4706.1 equivalent to the international standard (see 5.3, 5.4, 7.1.4, 8.1, 9.1); ● Replace IEC 61000-6-2 (see 5.4) with GB/T 17799.2 which is equivalent to adopting international standards; ● Replace IEC 61000-6-3 (see 5.4) with GB 17799.3 which is equivalent to adopting international standards; ● Replace ISO 11143 (see 5.5.1) with YY 0835 modified to adopt international standards; ● Replace ISO 5167-1 (see 7.2.1, 8.3) with GB/T 2624.1 which is equivalent to adopting international standards; ● Replace ISO 9687 (see 8.2) with YY/T 0628 which is equivalent to adopting international standards; ● Replace ISO 7010.2011 (see 9.2) with GB/T 31523.1 which is modified to adopt international standards; ---Modified the safety requirements, amended "shall meet the requirements of IEC 60335-1" to "shall meet the requirements of GB 4706.1 or GB 9706.1 "Requirements", amend "Test in accordance with IEC 60335-1" to "In accordance with GB 4706.1 or GB 9706.1 Test” (see 5.3), because it takes into account the actual implementation of medical electrical safety standards in the country; ---Added electromagnetic compatibility related requirements, and added "If the safety requirement is GB 9706.1, for electromagnetic compatibility, then YY 9706.102 applies. Test in accordance with the provisions of YY 9706.102" (see 5.4.2), the original clause is listed as 5.4.1, because To take into account the actual implementation of medical electrical safety standards in China; ---Modified other conditions, and revised "the conditions specified in IEC 60335-1 shall apply" to "GB 4706.1 or GB 9706.1" The conditions shall apply" (see 7.1.4), because the actual implementation of medical electrical safety standards in the country is taken into account; ---Modified the requirements outlined in the manufacturer's information, and amended "IEC 60335-1 shall apply" to "GB 4706.1 or GB 9706.1" The corresponding content in "Applies" (see 8.1), because it takes into account the actual implementation of medical electrical safety standards in the country; ---Modified the requirements for external marking, and amended "shall meet the requirements of IEC 60335-1" to "shall meet the requirements of GB 4706.1 or The requirements of GB 9706.1" (see 9.1), because it takes into account the actual implementation of medical electrical safety standards in the country; ---Modified the requirements for the connection point of the exhaust pipe, and replaced the "ISO 7010, symbol" with "No. 5-11 in GB/T 31523.1" W009” (see 9.2), make the numbers correspond. 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, Sino Medical Device Group Co., Ltd., Ningbo Lanye Medical Device Machinery Co., Ltd. The main drafters of this standard. Li Wei, Wu Yiming, Liang Chaohong, Zhao Lijun, Xu Yi, Ding Han, Yu Huatong. The previous versions of the standard replaced by this standard are as follows. ---YY/T 0629-2008; ---YY/T 0905.1-2016.

Introduction

Dental suction system removes solids, liquids, aerosols and gases from the oral cavity and surrounding areas to improve the operation during oral treatment Effect and efficiency, limit pollutants in the surrounding environment. In the central suction system, the equipment that generates suction and performs other supporting functions is located The central location outside the dental treatment room to isolate the device from the immediate area where the patient is being treated, and usually provide negative pressure to multiple treatment rooms. The central suction system consists of four basic elements. 1) Suction components for dental treatment rooms (e.g. suction systems for dental treatment machines); 2) Suction pipeline facilities; 3) Central suction source equipment; 4) Exhaust pipe. The central suction source equipment includes the connection point from the suction pipe facility (that is, the discharge end of the suction pipe facility) to the exhaust pipe connection point (that is, the exhaust pipe). All components of the gas pipeline inlet). In addition to the equipment that generates airflow, the central amalgam separator and the water-gas separator (if any) are also centrally pumped. An integral part of source suction equipment. Central suction source equipment for dentistry

1 Scope

This standard specifies the classification, requirements, test methods, manufacturer information, marking and packaging of stationary electric central suction source equipment, including Central amalgam separator and water vapor separator. This standard also stipulates that the manufacturer provides information on the performance, installation, operation and maintenance of the central suction source equipment as a whole dental pump. Part of the suction system. This standard applies to central suction source equipment that provides vacuum pressure and airflow at the connection point of the pipeline facility. This standard does not apply to portable suction source equipment, air/hydroventuri suction equipment, or suction source equipment located in the treatment room. This standard also does not apply to suction source equipment used for life support or removal of halogenated anesthetic gases. This standard does not include requirements for suction piping facilities and exhaust piping systems or treatment room equipment.

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 2624.1 Use a differential pressure device installed in a circular cross-section pipe to measure the flow of fluid in a full pipe. Part 1.General principles and Requirements (GB/T 2624.1-2006, ISO 5167-1.2003, IDT) GB 4706.1 Safety of household and similar electrical appliances Part 1.General requirements (GB 4706.1-2005, IEC 60335-1. 2004, IDT) GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020, IEC 60601-1.2012, MOD) GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD) GB/T 17799.2 Electromagnetic compatibility general standard industrial environment immunity test (GB/T 17799.2-2003, IEC 61000-6-2.1999, IDT) GB 17799.3 General Standard for Electromagnetic Compatibility. Emissions in Residential, Commercial and Light Industrial Environments (GB 17799.3-2012, IEC 61000-6-3.2011, IDT) GB/T 31523.1 Safety Information Identification System Part 1.Marking (GB/T 31523.1-2015, ISO 7010.2011, MOD) YY/T 0628 Graphical symbols for dental equipment (YY/T 0628-2020, ISO 9687.2015 AMD1.2018, IDT) YY 0835 Dental amalgam separator (YY 0835-2011, ISO 11143.2008, MOD) YY/T 1043.2 Dental treatment machine for dentistry Part 2.Gas, water, suction and waste water system (YY/T 1043.2-2018, ISO 7494-2.2015, IDT) YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance Capacity requirements and tests (YY 9706.102-2021, IEC 60601-1-2.2007, IDT) ISO 29463-1.2017 High-efficiency filters and filter media used to remove particles in the air Part 1.Classification, performance, testing And mark (Highefficiencyfiltersandfiltermediaforremovingparticlesfromair-Part 1.Classification, performance,testingandmarking)

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