YY/T 1696-2020 English PDFUS$129.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1696-2020: (Dental Sculpting Knife) Status: Valid
Basic dataStandard ID: YY/T 1696-2020 (YY/T1696-2020)Description (Translated English): (Dental Sculpting Knife) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C33 Word Count Estimation: 7,744 Date of Issue: 2020-06-30 Date of Implementation: 2021-12-01 Regulation (derived from): Announcement No. 76 (2020) of the National Medical Products Administration Issuing agency(ies): State Drug Administration YY/T 1696-2020: (Dental Sculpting Knife)---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.(Dental Sculpting Knife) ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standards Dental shaping knife (ISO 18556.2016,MOD) 2020-06-30 released 2021-12-01 implementation Issued by the National Medical Products Administration ForewordThis 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 18556.2016 "Dental Oral Shaping Knife". The main technical differences between this standard and ISO 18556.2016 and the reasons are as follows. ---Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and facilitate this standard The implementation of the standards and adjustments are collectively reflected in Chapter 2 "Normative Reference Documents". The specific adjustments are as follows. ● Replace ISO 6508-1 with GB/T 230.1 which is modified to adopt international standards; ● Replace ISO 6507-1 with GB/T 4340.1 modified to adopt international standards; ● Replace ISO 1942 (all parts) with GB/T 9937 (all parts), the degree of consistency between the parts of the two standards as follows. ● GB/T 9937.1-2008 Oral Vocabulary Part 1.Basic and Clinical Terminology (ISO 1942-1.1989, IDT); ● GB/T 9937.2-2008 Dental Vocabulary Part 2.Dental Materials (ISO 1942-2.1989, IDT); ● GB/T 9937.3-2008 Oral Vocabulary Part 3.Dental Devices (ISO 1942-3.1989, IDT); ● GB/T 9937.4-2005 Dental Terminology 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); ● Replace ISO 17664 with YY/T 0802 which is equivalent to adopting international standards. ---Added normative references and YY/T 0281 references (see Chapter 2, 5.5); ---Convert the steel grade to my country's applicable steel grade (see 5.2); ---Add the test method in "Handle and Blade Connection" (see 5.5); ---Some layout formats have been modified in accordance with GB/T 1.1-2009; ---The ISO preface is deleted. 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, Ningbo Lanye Medical Device Co., Ltd. The main drafters of this standard. He Yanying, Xu Suhua, Deng Xiaobin, Xu Buguang, Zhang Min. Dental shaping knife1 ScopeThis standard specifies the requirements and test methods for metallic and non-metallic intraoral shaping knives used to fill and shape tooth cavities with filling materials. Method, including disposable intraoral shaping knife. This standard also specifies the requirements for its marking. Note. Including devices used to place and shape non-metallic direct repair materials. This standard applies to intraoral shaping knives.2 Normative referencesThe 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 230.1 Rockwell hardness test of metallic materials Part 1.Test method (GB/T 230.1-2018, ISO 6508-1. 2016, MOD) GB/T 4340.1 Vickers hardness test of metallic materials Part 1.Test method (GB/T 4340.1-2009, ISO 6507- 1.2005, MOD) GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)] YY/T 0281 Test method for connection firmness of dental surgical instruments YY/T 0802 Medical device sterilization manufacturer provides information on the treatment of re-sterilizable medical devices (YY/T 0802- 2010, ISO 17664.2004, IDT)3 Terms and definitionsThe following terms and definitions defined in GB/T 9937 apply to this document. 3.1 Intraoralspatula A hand-held dental instrument with a flat blade for filling the tooth cavity with filling material and shaping the surface contour. It can be made of metal or non-metallic. Made of metal materials. 3.2 Non-metallic intraoral spatula Intraoral shaping knife made of plastic or ceramic material.4 categoriesDue to different design and material properties (such as shape, function, bending performance), the blades of the intraoral shaping knife are divided into the following types. ---Type 1.Oval, cut, hard; ---Type 2.Rectangular, smooth, flexible. ...... |
