ISO 23940:2021
Dentistry - Excavators

Standard No.

ISO 23940:2021

Release Date

2021

Published By

International Organization for Standardization (ISO)  IX  /  ISO

Latest

ISO 23940:2021

Introduction

Interpretation of the core content of the standard

The ISO 23940:2021 standard systematically specifies the physical characteristics and performance requirements of dental excavators, mainly including the following technical elements:

Technical dimensions	Requirements of the 1997 version	Updates to the 2021 version
Instrument classification	4 basic forms	6 new spoon-shaped variants (Form E 501-506)
Connection strength	600N tension/400Ncm torque	Reduced to 450N tension/0.25Nm torque
Labeling requirements	UDI not specified	New mandatory requirements for UDI coding

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Detailed explanation of key parameters

1. Instrument classification system

The standard divides excavators into 5 basic forms:

• Form A: Straight (100 series)
• Form B: Angled (200 series)
• Form C: Reverse-angle (300 series)
• Form D: Compound-angle (400 series)
• Form E: Spoon type (500 series, 6 new subtypes) 2. Material and hardness requirements Working end material must comply with ISO 21850-1 stainless steel standard, Vickers hardness range 550-800 HV1. The surface should be free of visible defects (pores, cracks, etc.) and production residues.

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  Clinical implementation recommendations

  Sterilization processing specifications

  The standard requires that the device must withstand 100 reprocessing cycles (cleaning-disinfection-sterilization). Key points:

  1. Follow the ISO 17664 processing guidelines provided by the manufacturer
  2. A total length exceeding 173mm may affect the loading of the sterilization box
  3. Check the integrity of the connection parts after each sterilization

  Key points of quality control

  It is recommended that medical institutions establish the following testing procedures:

  • Check the integrity of the UDI mark during incoming acceptance
  • Perform regular sampling for Vickers hardness testing
  • Perform quarterly random inspection of connection strength (450N tension/0.25Nm torque)

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  Technology Evolution Analysis

  The main technological advances of the 2021 version of the standard are reflected in:

  • Morphology expansion: Adding spoon-shaped excavators to meet the development needs of minimally invasive dentistry
  • Safety optimization: Reducing connection strength requirements to reduce the risk of instrument breakage
  • Traceability enhancement: Introducing the UDI system to improve the traceability of medical devices