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Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0905-2023: Dentistry - Central compressed air source equipment Status: Valid YY/T 0905: Historical versions
Basic dataStandard ID: YY/T 0905-2023 (YY/T0905-2023)Description (Translated English): Dentistry - Central compressed air source equipment Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C33 Classification of International Standard: 11.060.20 Word Count Estimation: 26,277 Date of Issue: 2023-09-05 Date of Implementation: 2025-03-15 Older Standard (superseded by this standard): YY/T 0905.2-2013 Issuing agency(ies): State Drug Administration Summary: This standard specifies the requirements for central compressed air source equipment that provides dental air for dental treatment machines and various dental air equipment in dental clinics, and describes the corresponding test methods. This document also specifies quality requirements and test methods for dental air produced by central compressed air source equipment, such as requirements for purification levels of dental air. This document also specifies the requirements for information to be provided by the manufacturer regarding the performance, installation, operation and maintenance of central compressed air source equipment. This document applies only to central compressed air source equipment located outside the dental treatment room. This document does not apply to central compressed air source equipment and facility ducts located within dental treatment rooms. This document does not include requirements for central compressed air source equipment for dental laboratory applications such as CAD/CAM systems. YY/T 0905-2023: Dentistry - Central compressed air 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.ICS 11.060.20 CCSC33 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 0905.2-2013 Dental central compressed air source equipment (ISO 22052.2020,MOD) Published on 2023-09-05 Implemented on 2025-03-15 Released by the State Drug Administration Table of contentsPreface III Introduction V 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 2 4 Category 4 5 Requirements 5 6 sampling 6 7 Test method 6 8 Information provided by the manufacturer7 9 mark 9 Appendix A (informative) Central compressed air source equipment design example 10 Appendix B (informative) Suggested template for test report 11 Appendix C (informative) Typical arrangements and construction and installation recommendations for central compressed air source equipment in dental facilities13 Reference 19ForewordThis document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces YY/T 0905.2-2013 "Dental Site Equipment Part 2.Compressor System" and is the same as YY/T 0905.2- Compared with.2013, in addition to structural adjustments and editorial changes, the main technical changes are as follows. ---Changed the scope of the standard (see Chapter 1, Chapter 1 of the.2013 edition), terms and definitions (see Chapter 3, Chapter 3 of the.2013 edition), Classification (see Chapter 4, Chapter 4 of the.2013 edition), electrical safety (see 5.1, 5.1 of the.2013 edition), dental air quality (See 5.3, 5.2.4, 5.2.7, 5.2.8, 5.2.15 of the.2013 edition), air delivery flow rate of central compressed air source equipment (see 5.4.1, 5.2.1 of the.2013 edition), condensate discharge (see 5.4.2, 5.2.6 of the.2013 edition), bacterial filter (see 5.4.3, 5.2.9 of the.2013 edition), information provided by the manufacturer (see Chapter 8, Chapter 7 of the.2013 edition), marking (see Chapter 9,.2013 version of Chapter 8); ---Added electromagnetic compatibility requirements (see 5.2), sound level of central compressed air source equipment (see 5.4.4), sampling (see Chapter 6) Require; ---Deleted the breather pipe (see 5.2.2 of the.2013 version), air intake silencer and air intake filter (see 5.2.3 of the.2013 version), air Gas storage tank (see 5.2.5 of the.2013 edition), compressed air main pipe (see 5.2.10 of the.2013 edition), compressor unit connection point (see 5.2.11 of the.2013 edition), stop valve (see 5.2.12 of the.2013 edition), connectors (see 5.2.13 of the.2013 edition), pressure The requirements for force regulating valves (see 5.2.14 of the.2013 edition) and compressor unit vents (see 5.2.16 of the.2013 edition) will be relevant The content has been adjusted to informative appendix C. This document is modified to adopt ISO 22052.2020 "Dental Central Compressed Air Source Equipment". Compared with ISO 22052.2020, this document has made the following structural adjustments. ---Adjust Appendix B of ISO 22052.2020 to Appendix C; adjust Appendix C of ISO 22052.2020 to Appendix B. The technical differences between this document and ISO 22052.2020 and their reasons are as follows. ---Replaced ISO 1942 (see Chapter 3) with normatively cited GB/T 9937 to adapt to my country's technical conditions and increase operability work nature; ---Replaced ISO 8573-2 (see 7.2.3.3) with normatively cited GB/T 13277.2 to adapt to my country's technical conditions, adding Operability; ---Replaced ISO 8573-3 (see 7.2.3.2) with normatively cited GB/T 13277.3 to adapt to my country's technical conditions, adding Operability; ---Replaced ISO 8573-4 (see 7.2.3.1) with normatively cited GB/T 13277.4 to adapt to my country's technical conditions, adding Operability; ---Replaced ISO 2151 (see 7.2.4) with normatively cited GB/T 21271 to adapt to my country's technical conditions and increase operability work nature; ---Replaced IEC 60335-1 (see 5.1) with normatively quoted GB 4706.1 to adapt to my country's technical conditions and increase operability work nature; ---Replaced IEC 60417 (see 9.3) with normatively quoted GB/T 5465.2 to adapt to my country's technical conditions and increase operability work nature; ---Replaced IEC 61000-6-2 [see 5.2a)] with the normatively cited GB/T 17799.2 to adapt to my country's technical conditions, adding Increase operability; ---Replaced IEC 61000-6-3 [see 5.2a)] with the normatively cited GB 17799.3 to adapt to my country's technical conditions, adding Operability; ---Replaced ISO 9687 (see 8.2) with normatively cited YY/T 0628 to adapt to my country's technical conditions and increase operability work nature; ---Replaced ISO 7494-2 (see Chapter 3) with normatively cited YY/T 1043.2 to adapt to my country's technical conditions, adding Operability; ---Added GB 4793.1 and GB/T 18268.1 (see 5.1, 5.2, 8.2, 8.3, 9.1, 9.2), taking into account the actual implementation of standards within the country; ---Changed the auxiliary verb in the clause expression in the classification, changing "central compressed air source equipment should be divided into the following two types" to "central Compressed air source equipment can be divided into the following two types" (see Chapter 4) to adapt to technological development; ---Electrical safety has been changed, changing "should comply with the requirements of GB 4706.1" to "should comply with the requirements of GB 4706.1 or GB 4793.1" "Requirements", change "should be tested according to GB 4706.1" to "should be tested according to GB 4706.1 or GB 4793.1" (see 5.1), Because taking into account the actual situation of the implementation of domestic standards for medical devices; ---Changed the electromagnetic compatibility requirements and added "If the safety requirements comply with GB 4793.1, then the requirements of GB/T 18268.1 shall comply with combine. The test should be carried out in accordance with GB/T 18268.1" [see 5.2b)], and 5.2 in the original clause ISO 22052.2020 is listed as 5.2a), Because considering the actual situation of domestic implementation standards of medical devices; ---Changed the instructions for use, changing "h) technical data in compliance with GB 4706.1" to "h) in compliance with GB 4706.1 or GB 4793.1 "Technical data" (see 8.2), because the actual implementation of standards for medical devices in the country is considered; ---The technical description has been changed, changing "v) technical data in compliance with GB 4706.1" to "v) in compliance with GB 4706.1 or GB 4793.1 "Technical data" (see 8.3), because the actual implementation of standards for medical devices in the country is considered; ---Changed the mark on the central compressed air source equipment, changing "according to GB 4706.1" to "according to GB 4706.1 or GB 4793.1” (see 9.1), because of considering the actual situation of the implementation of standards for medical devices in China; ---Changed the marking of the control device, changing "GB 4706.1 applicable" to "GB 4706.1 or GB 4793.1 applicable" (see 9.2), Because considering the actual situation of domestic implementation standards of medical devices; ---Deleted the 5.5 test report to adapt to the specific domestic conditions. The following editorial changes have been made to this document. ---Deleted the introductory words about the ISO and IEC terminology database URLs in "Terms and Definitions" (see Chapter 3). Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is sponsored by the Dental Equipment and Equipment Sub-Technical Committee of the National Technical Committee for Standardization of Oral Materials and Equipment (SAC/TC99/ SC1) Return to home. This document was drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Guangdong Falcon Technology Industrial Co., Ltd., Sino Medical Device Group Tuan Co., Ltd., Dier Medical Equipment (Shanghai) Co., Ltd. The main drafters of this document. Li Shi, Zhang Xu, Wu Yiming, Li Wei, Wang Chuang, Liang Chaohong, Zhang Weifeng, Yang Jianwei, Lei Kangning, Zhao Lijun. The previous versions of this document and the documents it replaces are as follows. ---First released in.2013 as YY/T 0905.2-2013; ---This is the first revision.IntroductionCentral compressed air source equipment is almost universally found in modern dental treatment facilities. It consists of components independent of the treatment room and is used to Compress air, prepare air that meets quality requirements and store dental air for pneumatic devices in the treatment room (such as pneumatic handpieces and three-way nozzles) gun) end use, as well as for cooling purposes. Since the output of a central compressed air source device is used for dental treatment, the performance of the device as well as the quality characteristics of the air supplied to the dentistry are important. is the subject of this document. The requirements specified in this document are developed taking into account the requirements for air for dental use specified in YY/T 1043.2. In medical applications, the quality of "medical air" is well defined. For example, there are similar definitions in the European Pharmacopoeia and other countries. Medical air is used for artificial respiration, anesthesia, endoscopy and other in vivo applications, as well as for long-term treatment. In addition, it is used for sterile environment, such as the operating room. For these applications, a more precise definition of air quality is necessary. The European Pharmacopoeia gives airborne substances Content values and limits, as well as limits for hazardous pollutants. In dental applications, compressed air is used to power treatment room pneumatic equipment such as pneumatic handpieces (drills) and to dry hands. surgical site. The air used for these purposes is intermittently introduced into the patient's mouth and can, to a large extent, be rapidly expelled through dental suction equipment. Since the ambient air in a dental treatment room is not sterile, there is no need to sterilize the dental air or to The substance content of the air used is controlled beyond the requirements of normal ambient air. However, air used in dentistry has some basic quality characteristics. a) Protect sensitive dental instruments and instruments (from oil, water, particles); b) Provide clean and dry air to prevent dental surgery from being affected (because oil is a release agent and will affect oral adhesion systems such as system, etc.); c) Prevent high humidity in the dental air from causing corrosion to air storage tanks and air ducts, and causing technical problems in dental instruments. malfunction; also prevents the growth of microorganisms in dental air systems. The test methods in this document were developed based on well-defined specifications for determining the quality of air for dental use. So far, there is no international standard defining the quality of "dental air". See Appendix A for relevant design examples of central compressed air source equipment. See Appendix B for a suggested template for the test report. Typical arrangements and construction and installation recommendations for central compressed air source equipment in dental facilities are provided in Appendix C. Dental central compressed air source equipment1 ScopeThis document specifies the central compressed air source equipment that provides dental air for dental treatment machines and various dental air equipment in dental clinics. equipment requirements, and the corresponding test methods are described. This document also specifies the quality requirements and test methods for dental air produced by central compressed air source equipment, e.g. Air purification level requirements. This document also specifies the requirements for information to be provided by the manufacturer regarding the performance, installation, operation and maintenance of central compressed air source equipment. This document applies only to central compressed air source equipment located outside the dental treatment room. This document does not apply to central compressed air source equipment and facility ducts located within dental treatment rooms. This document does not cover dental technicians requirements for central compressed air source equipment for room applications such as CAD/CAM systems.2 Normative reference documentsThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB 4706.1 Safety of household and similar electrical appliances Part 1.General requirements (GB 4706.1-2005, IEC 60335-1. 2004(Ed4.1),IDT) GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements (GB 4793.1-2007, IEC 61010-1.2001,IDT) GB/T 5465.2 Graphical symbols for electrical equipment Part 2.Graphical symbols (GB/T 5465.2-2008, IEC 60417DB. 2007,IDT) GB/T 9937 Dental terminology (GB/T 9937-2020, ISO 1942.2009, MOD) GB/T 13277.2 Compressed air Part 2.Measuring method of suspended oil content (GB/T 13277.2-2015, ISO 8573-2. 2007,MOD) GB/T 13277.3 Compressed air Part 3.Humidity measurement method (GB/T 13277.3-2015, ISO 8573-3.1999, MOD) GB/T 13277.4 Compressed air Part 4.Solid particle measurement method (GB/T 13277.4-2015, ISO 8573-4. 2001,MOD) GB/T 17799.2 Electromagnetic and general standard immunity test in industrial environment (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 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements (GB/T 18268.1-2010,IEC 61326-1.2005,IDT) GB/T 21271 Vacuum technology vacuum pump noise measurement (GB/T 21271-2007, ISO 2151.2004, MOD) YY/T 0628 Dental Dental Equipment Graphical Symbols (YY/T 0628-2020, ISO 9687.2015 AMD1.2018, IDT) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0905-2023_English be delivered?Answer: Upon your order, we will start to translate YY/T 0905-2023_English as soon as possible, and keep you informed of the progress. 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