YY/T 1746-2020 in English

VALID

Absorbable surgical suture—Test method for breaking strength in vitro hydrolytic degradation

Issued on:2020-09-27
Implemented on:2021-09-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $120.00
$117.00

Standard No:	YY/T 1746-2020
Document status:	VALID
Title in English:	Absorbable surgical suture—Test method for breaking strength in vitro hydrolytic degradation
Title in Chinese:	可吸收性外科缝线体外水解后断裂强力试验方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-09-27
Implemented on:	2021-09-01
ICS Classification:	11.040.30-Surgical instruments and materials
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	strength test absorbable surgical suture test method breaking strength retention value key test steps initial test breaks
Related Topics:	Crack test method breaking strength powerful Surgical Sutures suture water splitting UV Absorption Peak Absorption Intensity in vitro release method The outer absorption peak of pvc In vitro/be strong strong absorbent water splitting cracked water cracked water Hydrolysis test method a-cracking method In vitro myocardial contractility measurement Experimental method for fruit respiration intensity Solid food lysis method UV absorption cell matching test method

本标准规定了可吸收性外科缝线在体外模拟环境下的断裂强力保留值的试验方法。
本标准适用于水解降解的人工合成聚合物加工而成的可吸收性外科缝线。

Introduction

Analysis of the core content of the standard

Key parameters	Standard requirements	Technical significance
Material testing machine Gauge length	130mm±5mm	Ensure uniform distribution of tensile stress
Buffer pH value	7.4±0.2	Simulate the physiological environment of the human body
Oscillation frequency	60r/min	Accelerate the hydrolysis reaction process

Detailed explanation of key test steps

Initial breaking strength test requires 10 repeated tests to take the average value. Special attention: Class B sutures with specifications less than 8-0 must be tested in an untied state. If the test breaks within 1 cm of the fixture, the test must be discarded and retested.

Analysis of Standard Technology Evolution

This standard refers to ISO 13781:2017 international standard, and its main innovations include:

For the first time, the preparation ratio of phosphate buffer is clarified (18.2% KH₂PO₄ + 81.8% Na₂HPO₄·2H₂O)
A dynamic oscillating water tank is introduced to simulate the in vivo environment
A calculation formula for breaking strength retention (BSR) is established

Implementation Suggestions

Typical application case: A polylactic acid suture manufacturer found through testing based on this standard that after immersion in phosphate buffer at 37°C for 21 days, The breaking strength retention value of class=instrument>4-0 specification suture dropped from the initial 25N to 18N (BSR=72%), and the product sterilization process was optimized accordingly.

Implementation precautions:

The pH meter needs to be calibrated regularly (accuracy ≥0.02)
The ratio of test solution volume to suture mass ≥10:1
Different test cycles should be set for sutures of different materials

More samples: JC/T 2453-2018 JJG 21-2008 YD/T 3934-2021

Sample only — not a preview of YY/T 1746-2020

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