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YY/T 1696-2020Dentistry—Intraoral spatulas (English PDF)

牙科学 口内塑形刀

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 30, 2020

Implementation date

December 1, 2021

Scope

YY/T 1696-2020 is the English-translated version of 牙科学 口内塑形刀.

YY/T 1696-2020 is the Chinese pharmaceutical industry standard for intraoral spatulas, the metal and non-metal instruments with which a filling material is placed and shaped in a cavity, including single-use ones.

It sets the requirements, the test methods and the marking, covering the materials and their corrosion resistance, the shape and finish of the working ends, the stiffness and strength of the instrument, and, for reusable ones, the ability to be cleaned and sterilized.

Instruments used to place and shape non-metallic direct restorative materials are included. Issued on 30 June 2020, it has applied since 1 December 2021.

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Document preview — YY/T 1696-2020

National Standard of the People's Republic of China

Classification
C 33

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Categories

Foreword

This 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.

1 Scope

This 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 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 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 definitions

The 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 Categories

Due 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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

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