YY/T 0803.1-2022 (YY 0803.1-2010) PDF EnglishUS$260.00 · In stock · Download in 9 seconds
YY 0803.1-2010: Dentistry. Root-canal instruments. Part 1: General requirements and test methods Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY 0803.1: Historical versions
Similar standardsYY 0803.1-2010: Dentistry. Root-canal instruments. Part 1: General requirements and test methods---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0803.1-2010YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.060.20 C 33 YY 0803.1-2010 / ISO 3630-1.2008 Dentistry - Root-canal instruments - Part 1.General requirements and test methods (ISO 3630-1.2008, IDT) Issued on: DECEMBER 27, 2010 Implemented on: JUNE 01, 2012 Issued by. China Food and Drug Administration Table of ContentsForeword... 4 Introduction... 5 1 Scope... 6 2 Normative references... 6 3 Terms, definitions and symbols... 7 3.1 Terms and definitions... 7 3.2 Symbols... 9 4 Classification... 9 5 Requirements... 9 5.1 General... 9 5.2 Type 1.standard-sized instruments... 10 5.3 Type 2.taper-sized instruments... 11 5.4 Type 3.shape-sized instruments... 13 5.5 Type 4.non-taper-sized instruments... 13 5.6 Type 5.non-uniform taper-sized instruments... 14 5.7 Materials... 15 5.8 Dimensions... 16 5.9 Mechanical requirements... 16 5.10 Chemical requirements... 17 6 Sampling... 17 7 Test methods... 18 7.1 Visual inspection... 18 7.2 Test conditions... 18 7.3 Measurement of dimensions... 18 7.4 Resistance to fracture by twisting and angular deflection... 19 7.5 Stiffness... 21 7.6 Handle and shank security... 22 7.7 Corrosion test... 23 7.8 Heat effects of sterilization... 23 8 Designation, marking and identification... 24 8.1 General... 24 8.2 Identification symbols... 24 9 Packaging... 25 10 Manufacturer’s instructions for use... 25 11 Labelling... 25 References... 27ForewordAll technical contents of this Part are mandatory. YY 0803 consists of the following parts, under the general title Dentistry - Root-canal instruments. -- Part 1.General requirements and test methods; -- Part 2.Enlargers; -- Part 3.Condensers; -- Part 4.Auxiliary instruments. This Part is Part 1 of YY 0803. This Part is identical to ISO 3630-1.2008 Dentistry - Root-canal instruments - Part 1. General requirements and test methods (English version). The main differences between this Part and ISO 3630-1.2008 are as follows. -- Make some editorial modifications in accordance with the requirements of GB/T 1.1; -- Delete the foreword of the international standard; -- For other international standards cited in this Part, if they have been converted into Chinese standards, replace the referenced international standard number with the corresponding national or industry standard number, and indicate the adoption relationship in Chapter 2 of this Part. This Part shall be under the jurisdiction of Subcommittee 1 on Dental Equipment and Devices of National Technical Committee 99 on Dental Materials and Equipment of Standardization Administration of China (SAC/TC 99/SC 1). Drafting organization of this Part. Guangzhou Medical Device Quality Supervision and Test Institute of the China Food and Drug Administration, Shenzhen Superline Technology Co., Ltd. Chief drafting staffs of this Part. Lu Wenjuan, Wu Yiming, Peng Canguang, Wang Zhong. Dentistry - Root-canal instruments - Part 1.General requirements and test methods1 ScopeThis part of YY 0803 specifies general requirements and test methods for root-canal instruments used for endodontic purposes, e.g. enlargers, shaping and cleaning instruments, condensers, and accessory instruments. In addition it covers general size designations, colour coding, packaging and identification symbols.2 Normative referencesThe following documents, referenced by YY 0803, are indispensable for the application of this document. For dated references, all subsequent amendments (not including errata content) or revisions do not apply to this Part. However, parties to agreements that are based on this Part are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest edition applies to this Part. GB/T 7408, Data elements and interchange formats - Information interchange - Representation of dates and times (GB/T 7408-2005, ISO 8601.2000, IDT) GB/T 9937, Dentistry - Vocabulary (all parts) (GB/T 9937-2008, ISO 1942, IDT) YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1.General requirements (YY/T 0466.1-2009, ISO 15223.2007, IDT) YY 0803.2-2010, Dental root-canal instruments - Part 2.Enlargers (ISO 3630- 2.2000, IDT) ISO 554, Standard atmospheres for conditioning and/or testing - Specifications ISO 1797-1.1992, Dental rotary instruments - Shanks - Part 1.Shanks made of metals ISO 1797-2.1992, Dental rotary instruments - Shanks - Part 2.Shanks made of plastics ISO 3696.1987, Water for analytical laboratory use - Specification and test methods ISO 6360-2, Dentistry - Number coding system for rotary instruments - Part 2. Shapes ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
