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YY/T 1693-2020Dentistry - Sinus membrane elevator (English PDF)

牙科学 上颌窦膜提升器

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 26, 2020

Implementation date

September 1, 2021

Scope

YY/T 1693-2020 is the English-translated version of 牙科学 上颌窦膜提升器.

YY/T 1693-2020 is the Chinese pharmaceutical industry standard for the sinus membrane elevator, the dental instrument used to lift the Schneiderian membrane when the maxillary sinus floor is raised before an implant is placed.

It sets the classification of these instruments, the requirements they must meet and the test methods for them, together with the requirements for marking and labelling.

The requirements cover the materials and their corrosion resistance, the shape and finish of the working end, the strength of the joint between working end and handle, cleanability and sterilization. Issued on 26 February 2020, it has applied since 1 September 2021.

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Document preview — YY/T 1693-2020

National Standard of the People's Republic of China

ICS
11.060.25
Classification
C 33

Issued by: National Medical Products Administration of the People's Republic of China

Contents

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

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.

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 document. 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

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