YY/T 1604-2018 English PDFUS$439.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1604-2018: Dentistry--Rotary polishers Status: Valid
Basic dataStandard ID: YY/T 1604-2018 (YY/T1604-2018)Description (Translated English): Dentistry--Rotary polishers Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C33 Classification of International Standard: 11.060.20 Word Count Estimation: 22,291 Date of Issue: 2018-01-19 Date of Implementation: 2019-01-01 Quoted Standard: GB/T 2828.1; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; YY/T 0805.3; YY/T 0873.1; YY/T 0873.2; YY/T 0873.6; YY/T 0874-2013; YY/T 0913-2015; YY/T 0967.1-2015; YY/T 0967.2-2015 Adopted Standard: ISO 21671-2006/AMD-2011, MOD Regulation (derived from): China Food and Drug Administration announced No. 8 of 2018 Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the dimensional requirements and other requirements for the most commonly used polishing instruments in dental laboratories and dental clinics. This standard applies to unassembled or assembled polishing instruments. YY/T 1604-2018: Dentistry--Rotary polishers---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.Rotary polishers ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standard Dental Rotary Polishing Instruments (ISO 21671.2006/Amd1.2011,MOD) Published on.2018-01-19 2019-01-01 Implementation The State Food and Drug Administration issued Directory Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms, definitions and symbols 1 4 Request 2 5 Unassembled polishing instruments 4 6 Assembled Polishing Instruments 8 7 Test method 16 8 Sampling and Receiving Quality Limit (AQL) 16 9 Logo 16 10 labels 17 11 Packaging 17 Reference 18 ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafted law to amend ISO 21671.2006 A1.2011 "Dental Rotary Polishing Instruments". The main differences between this standard and ISO 21671.2006 A1.2011 are as follows. --- With regard to the standard reference documents, this section made adjustments with technical differences to adapt to China's technical conditions and adjust the situation. The focus is reflected in Chapter 2, "Normative References," and the specific adjustments are as follows. ● Use GB/T 9937 (all parts) instead of ISO 1942 (all parts), the degree of consistency between the two parts of the standard as follows. ◆ GB/T 9937.1-2008 Oral Vocabulary Part 1. Basic and Clinical Terms (ISO 1942-1.1989, IDT); ◆ GB/T 9937.2-2008 Oral Vocabulary Part 2. Oral Materials (ISO 1942-2.1989, IDT); ◆ GB/T 9937.3-2008 Oral Vocabulary Part 3. Oral Instruments (ISO 1942-3.1989, IDT); ◆ GB/T 9937.4-2005 Oral Vocabulary Part 4. Dental Equipment (ISO 1942-4.1989, IDT); ◆ GB/T 9937.5-2008 Oral Vocabulary Part 5. Terms related to testing (ISO 1942-5.1989, IDT). --- As 4.3 has been detailed in the unit of size and angle, so delete the right in Figure 4, Figure 7, and Figure 8 in ISO 21671.2006 The expression "in millimeters" above. --- Corrected some printing errors in ISO 21671.2006. The "c0.5" under the first line d3 of table 10 was changed to "±0.5". Table 20 The diameter d1 of the working part corresponding to the nominal diameter code and the nominal size 050 of the five rows is changed from "5.4" to "5.0". Table 23 The nominal diameter and nominal size of the second row were changed from "060" to "050". --- As indicated in 4.3.2.1, "The rods of assembled polishing instruments should be Type 1, Type 2, Type 3 in YY/T 0967.1-2015. Or type 4. ”, so under section 10(c) “If applicable, the type of shaft conforming to ISO 1797” is amended to “If applicable, in line with "Shaft type of YY/T 0967.1-2015". For ease of use, this standard has made the following editorial changes. --- Some editorial changes were made in accordance with the requirements of GB/T 1.1; --- Delete the preface and introduction of international standards; --- For other international standards cited in this standard, if they have been converted into Chinese standards, this standard will replace the referenced international standard number with Corresponding national or industry standard number, and indicate the adoption relationship in Chapter 2 of this standard. Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard consists of the National Dental Materials and Devices Equipment Standardization Technical Committee Dental Equipment and Devices Subcommittee (SAC/TC99 SC1) centralized. This standard was drafted. Guangdong Provincial Institute of Medical Device Quality Supervision and Inspection, Hangzhou New Asia Dental Material Co., Ltd., Ningbo Xinyuan Dental Instrument Machinery Co., Ltd. The main drafters of this standard are Fang Fang, Yan Lin, Huang Minju, Xie Xinyi, Wu Yiming, Lei Xiufeng, Chen Xianming, and Zhi Zhimeng.IntroductionThis standard is one of the standards for dental rotary instruments. The dimensions and other requirements of the polishing instruments specified in this standard shall ensure the interchangeability of these instruments in dental laboratories and dental clinics. Sexual and safe use is important. The nominal diameters of the working parts listed in Chapters 5 and 6 are the same as those specified in YY/T 1011-2014. It should be noted that a 15-digit digital coding system is given in YY/T 0873 “Digital Coding System for Dental Rotary Instruments”. To divide all types of dental rotary instruments. Dental Rotary Polishing Instruments1 ScopeThis standard specifies the dimensional requirements and other requirements for the most commonly used polishing instruments in dental laboratories and dental clinics. This standard applies. For unassembled or assembled polishing instruments.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 2828.1 Count Sampling Inspection Procedures Part 1. Batch Inspection Sampling Plans Retrieved by Acceptance Quality Limit (AQL) (GB/T 2828.1-2012, ISO 2859-1.1999, IDT) GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)] YY/T 0805.3 Dental Rotating Diamond Instruments - Part 3. Particle size, nomenclature, and color code (YY/T 0805.3- 2010, ISO 7711-3.2004.IDT) YY/T 0873.1 Digital coding system for dental rotary instruments - Part 1. General characteristics (YY/T 0873.1-2013, ISO 6360-1.2004, IDT) YY/T 0873.2 Digital coding system for dental rotary instruments - Part 2. Shape (YY/T 0873.2-2014, ISO 6360-2.2004, IDT) YY/T 0873.6 Digital coding system for dental rotary instruments - Part 6. Characteristics of abrasive instruments (YY/T 0873.6- 2015, ISO 6360-6.2004, IDT) YY/T 0874-2013 Dental Laboratory Rotating Instruments Test Method (ISO 8325.2004, IDT) YY/T 0913-2015 Spindles for Dental Rotary Instruments (ISO 13295.2007, MOD) YY/T 0967.1-2015 Dental Rotary Instrument Poles Part 1. Metal Rods (ISO 1797-1.1992, MOD) YY/T 0967.2-2015 Dental rotating instrument poles - Part 2. Plastic rods (ISO 1797-2.1992, MOD) 3 Terms, definitions and symbols 3.1 Terms and Definitions The terms and definitions defined in GB/T 9937 and the following apply to this document. 3.1.1 Polishing equipment polisher Rotary instruments for polishing dental materials or teeth in dentistry. 3.1.2 Assembled polishing apparatus mountedpolisher A non-detachable polishing instrument that is mounted on the rod. 3.1.3 Unassembled polishing equipment unmountedpolisher The delivery device does not have a polishing device with a fixture or rod, but it can be assembled to a fixture or mandrel with a clamp or a screw. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1604-2018_English be delivered?Answer: Upon your order, we will start to translate YY/T 1604-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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