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GB/T 41426-2022 in English

GB/T 41426-2022 in English

VALID

Dentistry—Integrated dental floss and handles

  • Issued on:2022-04-15
  • Implemented on:2022-11-01
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $250.00
$243.00
Standard No: GB/T 41426-2022
Document status: VALID
Title in English: Dentistry—Integrated dental floss and handles
Title in Chinese: 牙科学 一体式手柄牙线
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2022-04-15
Implemented on: 2022-11-01
ICS Classification: 97.170-Body care equipment
Chinese Classification: C33-Stomatologic device, equipment and material
Professional Classification: GB-National Standard
Related Topics: science
first-class discipline
first-class subject
One Stop Science
One-stop second-hand waters
handle
frontline scientists
scientific version
Dentistry
Science One
six one scientist
Two meals a day is the most scientific
GBT41426
GB/T 41426-2022
tooth
Adjustable handle tooth shape
dental floss
gb/t 41426
gb/t 41426-2022

《GB/T 41426-2022牙科学 一体式手柄牙线》由TC99(全国口腔材料和器械设备标准化技术委员会)归口,主管部门为国家药品监督管理局。


Introduction

Core Competitiveness and Technological Evolution

As an equivalent adopted standard of ISO 28158:2018, this document realizes for the first time a dual-modal detection system of static test device and tensile test equipment test methods...


Key Technical Indicators Comparison

Detection Dimensions Static Test Method Tensile Test Method
Loading Method Fixed 10N Gravity Dynamic 0-10N Uniform Load
Test Duration Last for 10 seconds ≤30 seconds to complete
Evaluation criteria Fracture/displacement>10mm is considered a failure

Device compliance implementation steps

Three stages of enterprise compliance

  1. Material screening: Recycled materials are prohibited, and biocompatible materials
  2. Dental floss composite verification: Wax layer adhesion requires 48H temperature change test
  3. 1300cc force verification: Complete three test batches according to Appendix A/B

Clinical use risk warning

  • Risk of excessive displacement: When the deformation of the floss/handle connection area is greater than 8mm, the injection molding parameters must be checked
  • Packaging sterilization verification: EO residue and extractable tests must be included

Sample only — not a preview of GB/T 41426-2022
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