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YY/T 1683-2019 English PDF

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YY/T 1683-2019: Dentistry - Osteotome
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PDF similar to YY/T 1683-2019


Standard similar to YY/T 1683-2019

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Basic data

Standard ID YY/T 1683-2019 (YY/T1683-2019)
Description (Translated English) Dentistry - Osteotome
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.01
Word Count Estimation 12,122
Date of Issue 2019
Date of Implementation 2021-04-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements and test methods for osteotome used in dental procedures such as bone extrusion, maxillary sinus lift, and jaw splitting. It also specifies the requirements for the labelling of such products. This standard applies to dental instruments used in dental surgery osteotome. This standard does not apply to orthopedic chisels used in orthopedic surgery.

YY/T 1683-2019: Dentistry - Osteotome

---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-Osteotome ICS 11.060.01 C33 People's Republic of China Pharmaceutical Industry Standard Dental chisel (ISO 17937..2015, MOD) Published on October 23,.2019 2021-04-01 implementation Published by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafting method to modify and adopt ISO 17937..2015 "Dental Dentistry". Compared with ISO 17937..2015, the main differences between this standard are as follows. --- Some layout formats have been modified according to GB/T 1.1-2009; --- The word "this international standard" was changed to "this standard"; --- Removed the foreword of international standards; --- Modified the content of the work end mark (see 7.2.1 Overview); --- Increased the test method for the impact strength of the connection between the rod and the handle (see 8.5.3 Impact test) --- Regarding the normative references, this standard has made adjustments with technical differences to suit China's technical conditions and the situation of adjustment. The situation is reflected in Chapter 2 "Regulatory Reference Documents", and the specific adjustments are as follows. ● ISO 6508-1 was replaced with GB/T 230.1 which adopted the international standard; ● Replaced ISO 6507-1 with GB/T 4340.1, which adopted the international standard; ● GB/T 9937 (all parts) instead of ISO 1942 (all parts), the degree of consistency between the two standards 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 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). ● Replaced ISO 15087-1 with YY/T 0170 which adopted the international standard; ● Replaced ISO 13504 with YY/T 1486 equivalent to the international standard; ● Replaced ISO 16443 with YY/T 1619 equivalent to the international standard. Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is supported by the National Dental Materials and Devices Standardization Technical Committee of the Dental Equipment and Devices Subcommittee (SAC/TC99 SC1) Centralized. This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Guangzhou Xifu Medical Equipment Co., Ltd., Hangzhou Xinya Dental Materials Materials Co., Ltd., Shandong Xinhua Medical Devices Co., Ltd. The main drafters of this standard. Huang Minju, Huang Yuzhe, Zeng Zhixiong, Li Jiyan, Zhang Degui, Chen Xianming, and Cai Chuanwen.

Introduction

Osteotomy is a surgical instrument commonly used in plastic surgery. However, in dental surgery, when preparing an implant site for a dental implant At present, some types of osteotome are used for bone compression, maxillary sinus lifting and jaw splitting. These types of osteotome are explained in this standard. Dental chisel

1 Scope

This standard specifies the requirements and test methods for dental chisels used in dental surgery such as bone compression, maxillary sinus lifting, and jaw splitting. It also stipulates the requirements for marking and labeling of this type of products. This standard applies to dental instruments used in dental surgery. This standard does not apply to orthopedic chisels used in orthopedic surgery.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 230.1 Rockwell hardness test for metallic materials-Part 1. Test method (GB/T 230.1-2018, ISO 6508-1. (2016, MOD) GB/T 4340.1 Vickers hardness test for 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 0170-2011 Teeth (ISO 15087-1..1999, MOD) YY/T 1486 General requirements for dental implant equipment and related auxiliary equipment (YY/T 1486-2016, (ISO 13504..2012, IDT) YY/T 1619 Terminology of dental implant systems and related processes (YY/T 1619-2018, ISO 16443..2014, IDT) 3 Terms, definitions and symbols 3.1 Terms and definitions GB/T 9937 (all parts), YY/T 1486 and YY/T 1619 as well as the following terms and definitions apply to this document. 3.1.1 Dental chisel osteotome Hand-held dental instruments designed for dental surgery such as bone compression, maxillary sinus lifting, and jaw splitting. Note. The dental bone chisel is composed of a working front end, a rod and a handle. 3.1.2 Squeezer Bone squeezer bone-condenser A handheld dental instrument with a conical working end improves the initial stability of the implant by squeezing the maxilla around the implant socket. 3.1.3 Bone splitter chisel Hand-held dental instruments designed to split the jawbone to form buccal and lingual or buccal and palatal bone plates with implants implanted between them. NOTE. Bone splitters can also be used selectively to remove the patella during implant and transplant procedures.

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