Valid

YY/T 1622.1-2018Dentistry—Periodontal probes - Part 1: General requirements (English PDF)

牙科学 牙周探针 第1部分:通用要求

Preview PDF

This is a limited preview

Buy now to download the full PDF (24 pages)

Need quotation for your management?

Get a formal quotation for YY/T 1622.1-2018 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

November 7, 2018

Implementation date

November 1, 2019

Scope

YY/T 1622.1-2018 is the English-translated version of 牙科学 牙周探针 第1部分:通用要求.

YY/T 1622.1-2018 is the Chinese pharmaceutical industry standard that sets the general requirements and test methods for periodontal probes, the graduated probes with which pocket depth is measured.

It is the first part of the YY/T 1622 series and applies to probes made of austenitic or martensitic stainless steel, covering the dimensions and the tip diameter, the graduation marks and their accuracy and legibility, the stiffness of the working end, the corrosion resistance and the ability to be cleaned and sterilized.

It does not apply to probes whose working end is entirely plastic, nor to the probe types it excludes by name. Issued on 7 November 2018, it has applied since 1 November 2019.

Found what you need?

Document preview — YY/T 1622.1-2018

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

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 terms, definitions and symbols
  • 4 Category
  • 5 Requirements
  • 6 Test method
  • 7 labels and logos

Foreword

YY/T 1622 "Dental Periodontal Probe" is divided into two parts.

--- Part 1. General requirements;

--- Part 2. Identification. This part is part 1 of YY/T 1622.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This section uses the redrafting method to modify the use of ISO 21672-1:2012 "Dental Periodontal Probes Part 1. General Requirements".

The technical differences between this part and ISO 21672-1:2012 are as follows.

--- Modified 5.1 "shape and size";

--- Removed Appendix 15 of ISO 15087-1:1999 in 5.2.4.1;

--- Revised the requirements for tensile load, torque, hardness and stiffness in 5.6 and 5.7;

--- Revised the requirements for corrosion resistance of periodontal probes in 5.7;

--- For other international standards cited in this section, if it has been converted to Chinese standards, this section replaces the referenced international standard number with Corresponding national standard number, and indicate the adoption relationship in Chapter 2.

This section has also made the following editorial changes compared to the original.

--- Removed the preface to international standards.

1 Scope

This part of YY/T 1622 specifies the general requirements and test methods for periodontal probes.

This section applies to periodontal probes made of austenitic stainless steel or martensitic stainless steel.

This section does not apply to periodontal probes made entirely of plastic at the working end, nor to HAUER probes and can be set up. A prosthetic probe for the detection force.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 228.1 tensile testing of metallic materials - Part 1. Test methods for room temperature (GB/T 228.1-2010, ISO 6892-1. 2009, MOD)

GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1. Test methods (GB/T 4340.1-2009, ISO 6507- 1.2005, MOD)

GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)]

YY/T 0149-2006 Test Method for Corrosion Resistance of Stainless Steel Medical Devices (ISO 13402:1995, MOD)

YY/T 0294.1 Metal materials for surgical instruments - Part 1. Stainless steel (YY/T 0294.1-2005, ISO 7153-1:1991, MOD)

YY/T 0820-2010 Information on the treatment of re-sterilizable medical devices provided by the sterilization manufacturer of medical devices (0802- 2010, ISO 17664:2004, IDT)

3 Terms, definitions and symbols

3.1 Terms and definitions

The following terms and definitions as defined in GB/T 9937 apply to this document.

3.1.1 Periodontal probe

Dental handpiece for measuring the depth of the periodontal pocket, diagnosing and evaluating the periodontal pocket environment.

3.1.2 Root fork probe furcationprobe

Periodontal probe for detecting premolars and molar root bifurcations.

3.2 Symbol

The following symbols apply to this document. R1. Rod radius. R2. Working radius. B1. edge thickness.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

How to Download YY/T 1622.1-2018

  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
24 pages
Instant delivery (0–9 sec)
Invoice included
View Cart

Secure payment via Stripe

Payments accepted

VisaMastercardAmerican ExpressApple PayGoogle PayStripe

YY/T 1622.1-2018

$185.00