Valid

YY/T 1683-2019Dentistry — Osteotome (English PDF)

牙科学 牙骨凿

Preview PDF

This is a limited preview

Buy now to download the full PDF (21 pages)

Need quotation for your management?

Get a formal quotation for YY/T 1683-2019 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

October 23, 2019

Implementation date

October 1, 2020

Scope

YY/T 1683-2019 is the English-translated version of 牙科学 牙骨凿.

YY/T 1683-2019 is the Chinese pharmaceutical industry standard for the dental osteotome, the chisel used in oral surgery to compress bone, to lift the maxillary sinus floor and to split the ridge.

It sets the requirements and the test methods, and the marking and labelling of such instruments, covering the materials and their hardness and corrosion resistance, the shape and finish of the working end, the strength of the instrument under impact and bending and its ability to be cleaned and sterilized repeatedly. Issued on 23 October 2019, it has applied since 1 October 2020.

Found what you need?

Document preview — YY/T 1683-2019

National Standard of the People's Republic of China

ICS
11.060.01
Classification
C 33

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

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms, definitions and symbols

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.

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 document. 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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

How to Download YY/T 1683-2019

  1. 1

    Add to cart

    Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.

  2. 2

    Checkout

    Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).

  3. 3

    Instant delivery (0–9 sec)

    Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.

  4. 4

    Invoice included

    A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.

Related Standards

English PDF
21 pages
Instant delivery (0–9 sec)
Invoice included
View Cart

Secure payment via Stripe

Payments accepted

VisaMastercardAmerican ExpressApple PayGoogle PayStripe

YY/T 1683-2019

$205.00