YY/T 1693-2020 English PDF

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YY/T 1693-2020: Dentistry--Sinus membrane elevator
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1693-2020	169	Add to Cart	3 days	Dentistry--Sinus membrane elevator	Valid

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Basic data

Standard ID: YY/T 1693-2020 (YY/T1693-2020)
Description (Translated English): Dentistry--Sinus membrane elevator
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.25
Word Count Estimation: 9,999
Date of Issue: 2020-02-26
Date of Implementation: 2021-09-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the classification, requirements and test methods of maxillary sinus membrane lifters used for maxillary sinus lift during dental implant placement. This standard also specifies requirements for marking and labelling. This standard applies to maxillary sinus membrane lifters used for maxillary sinus lift during dental implant placement.

YY/T 1693-2020: Dentistry--Sinus membrane elevator

---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--Sinus memberane elevator ICS 11.060.25 C33 People's Republic of China Pharmaceutical Industry Standard Dentistry Maxillary Sinus Membrane Lifter (ISO 19490.2017, MOD) 2020-02-26 released 2021-09-01 implementation Issued by the State Drug Administration

Table of contents

Preface Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Category 2 5 Requirements 2 5.1 Working end material 2 5.2 Handle material 2 5.3 Size 2 5.4 Appearance 2 5.5 Repetitive processing resistance 2 5.6 Hardness of working end 2 5.7 Connection of rod and handle 2 5.8 Shape of the working end 2 6 Test method 4 6.1 Length measurement 4 6.2 Appearance test 4 6.3 Repeated handling resistance test 4 6.4 Hardness test 4 6.5 Connection of rod and handle 4 6.5.1 Tensile test 4 6.5.2 Torque test 4 7 Mark 4 7.1 Device marking 4 7.2 Packaging label 4 7.3 Instructions for use 4 Reference 5

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 19490.2017 "Dental Maxillary Sinus Membrane Elevator". The technical differences between this standard and ISO 19490.2017 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 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 Terms (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 Dental 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.Terminology Related to Testing (ISO 1942-5.1989, IDT); ● Replace ISO 15087-1 with YY/T 0170-2011 modified to adopt international standards; ● Replace ISO 13504.2012 with YY/T 1486-2016 which is equivalent to adopting international standards; ● Replace ISO 16443 with YY/T 1619 which is equivalent to the international standard. --- Replace ISO 15087-1 Appendix C with the corresponding YY/T 0170-2011 Appendix A in "6.5.1 Tensile Test"; ---In "6.5.2 Torque Test", replace ISO 15087-1 Appendix D with the corresponding YY/T 0170-2011 Appendix A. This standard has made the following editorial changes. ---According to GB/T 1.1-2009, some layout formats have been modified; --- "This International Standard" is changed to "This Standard"; ---The foreword of the international standard is deleted. Please note that certain 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, Hangzhou Xinya Dental Materials Co., Ltd., Ningbo Lanye Medical Devices Machinery Co., Ltd. The main drafters of this standard. Zhou Liangbin, Wu Yiming, He Yanying, Chen Ying, Yuan Qin, Chen Xianming, Xu Buguang.

Introduction

The maxillary sinus membrane lifter is used for dentistry for maxillary sinus lift surgery that increases the thickness of the bone layer in the vertical direction during the placement of dental implants. instrument. The types of these maxillary sinus membrane lifters are listed in this standard. Dentistry Maxillary Sinus Membrane Lifter

1 Scope

This standard specifies the classification, requirements and tests of maxillary sinus membrane lifters used for maxillary sinus elevation during dental implant placement method. This standard also specifies requirements for marking and labeling. This standard applies to the maxillary sinus membrane elevator used for maxillary sinus elevation during dental implant placement.

2 Normative references

The 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 references, the latest version (including all amendments) applies 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 0170-2011 dental elevator (ISO 15087-1.1999, MOD) YY/T 1486-2016 General requirements for dental implant equipment and related auxiliary equipment (ISO 13504.2012, IDT) YY/T 1619 Dental implant system and related process terms (YY/T 1619-2018, ISO 16443.2014, IDT)

3 Terms and definitions

GB/T 9937 (all parts), YY/T 1486-2016 and YY/T 1619 and the following terms and definitions apply to this file. 3.1 Maxillary sinus membrane lifter Hand-held dental instruments used to lift or shift the maxillary sinus membrane (maxillary sinus floor) through the sidewall of the maxillary sinus or the top of the alveolar ridge to increase bone mass Implant placement. Note. The maxillary sinus membrane lifter includes a working head (3.3) and a rod connected to the handle. The device may be double-ended. 3.2 Working end The part of the maxillary sinus membrane lifter consisting of a working head (3.3) and a rod connected to the handle. 3.3 Working head The functional part of the working end (3.2) will first contact the bone and maxillary sinus membrane.

4 categories

According to this standard, maxillary sinus membrane lifters should be divided into the following types according to their maxillary sinus lifting methods. ---Type 1.Sidewall/vestibule/external approach; ---Type 2.Vertical/Alveolar crest/internal approach.

5 requirements

5.1 Working end materials The working end should be made of materials conforming to YY/T 1486-2016. 5.2 Handle material The handle material of the maxillary sinus membrane elevator should be specified by the manufacturer. 5.3 Dimensions The overall length shall be specified by the manufacturer. Note. The total length of more than 178mm may cause it to be unable to be placed in trays and boxes for repeated processing. 5.4 Appearance The device shall have no visible surface defects when tested in accordance with 6.2. 5.5 Repetitive processing resistance According to the method tested in 6.3, there should be no obvious deterioration or corrosion. 5.6 Hardness of working end According to the method of 6.4, the hardness of the working end of the device should not be less than 480HV1 or 48HRC. 5.7 Connection of rod and handle The maxillary sinus membrane lifter assembled by the rod and handle should not be loosened after the tensile test and torque test described in 6.5. 5.8 Shape of working end The shape of the working end and working head shall be specified by the manufacturer. Figures 1 to 3 are only examples. Working end and working head can also have other design.

6 Test method

6.1 Length measurement Use a measuring instrument whose accuracy is less than 1/10 of the product size tolerance for length measurement. 6.2 Appearance test Use normal visual inspection without using a magnifying glass. 6.3 Repeated handling resistance test Follow the manufacturer's instructions for 100 repetitions of the device. Repetitive treatment includes cleaning, disinfection and/or sterilization methods recommended by the manufacturer law. Check for any corrosion/surface defects on the surface of the device in accordance with 6.2.Repeat the hardness test of 6.4. 6.4 Hardness test Test Vickers hardness or Rockwell hardness according to the method in GB/T 4340.1 or GB/T 230.1. 6.5 Connection of rod and handle 6.5.1 Tensile test Apply a pulling force of 1000N at the connection between the rod and the handle, parallel to the centerline of the handle, for 5s, according to YY/T 0170-2011 In the method described in Appendix A. 6.5.2 Torque test Apply a torque of 500N·cm at the connection between the rod and the handle for 5s, as described in Appendix A in YY/T 0170-2011 Method to proceed.

7 mark

7.1 Device marking The device marking should meet the requirements of 11.2 in YY/T 1486-2016. 7.2 Packaging label The label on the package should meet the requirements of 11.1 and 11.3 in YY/T 1486-2016. 7.3 Instructions for use Instructions for use should meet the requirements of 11.4 and below in YY/T 1486-2016. The description of the instructions for use should include repeated treatment methods for instrument cleaning, disinfection and/or sterilization. references ......

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