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YY/T 1746-2020 (YY/T1746-2020)

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YY/T 1746-2020: PDF in English (YYT 1746-2020)
YY/T 1746-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 30
Absorbable surgical suture - Test method for breaking
strength in vitro hydrolytic degradation
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Principle ... 4 
3 Apparatus and reagents ... 4 
4 Test procedure ... 5 
5 Test report ... 7 
References ... 8 
Absorbable surgical suture - Test method for breaking
strength in vitro hydrolytic degradation
1 Scope
This Standard specifies the test method for the retention value of breaking
strength of absorbable surgical suture (hereinafter referred to as suture) in the
in vitro simulated environment.
This Standard applies to the absorbable surgical suture which is processed
from synthetic polymers that are hydrolyzed and degraded.
2 Principle
Test the retention value of suture breaking strength in different time periods in
an in vitro simulated environment, which provides reference information for
whether the suture can maintain sufficient tension during the critical period of
wound healing.
3 Apparatus and reagents
3.1 Material testing machine
The tensile speed is 300 mm/min ± 10 mm/min; the test gauge length is 130
mm ± 5 mm.
Note: If the suture length cannot meet the requirements of the specified test
gauge length, the test gauge length can be adjusted according to the
actual length of the suture; the corresponding stretching speed is set to
2 times the adjusted test gauge length. If the adjusted test gauge length
is set to 50 mm, the stretching speed is set to 2×50 = 100 mm/min.
3.2 Electric-heating constant-temperature oscillating water tank or constant-
temperature oscillator
The temperature is 37 °C ± 1 °C; the oscillation frequency: 60 r/min (or other
suitable oscillation methods).
3.3 pH meter
The accuracy of the pH meter is not less than 0.02.
3.4 Container
4.2.4 Calculate the average of the 10 recorded force values, which is the initial
breaking strength.
4.3 Test of residual breaking strength
4.3.1 Take 10 sutures of the same batch as the initial test value (4.2); put them
into the container (3.4), so that the sutures are completely immersed in the test
solution (3.5) (the ratio of the volume of the test solution to the mass of the
suture is at least 10 mL:1 g).
Note: If the suture length can meet the test conditions, take the same suture to
test the initial breaking strength value and the residual breaking strength
value, respectively.
4.3.2 Place the container in the electric-heating constant-temperature
oscillating water tank (3.2); select the corresponding test period according to
the material of the suture and the intended use. During the test period, the pH
value of the test solution in the container shall be monitored as needed. If the
pH value of the buffer exceeds the specified limit value (7.4 ± 0.2), use the 0.1
mol/L sodium hydroxide solution or dilute phosphoric acid to adjust or replace
the buffer, to make it meet the requirements (3.5).
4.3.3 At the end of the test period, take out the suture and remove the water on
the surface of the suture until there is no dripping.
Note: The method of removing water shall not affect the breaking strength of
the suture.
4.3.4 Carry out the test according to steps 4.2.1 ~ 4.2.3.
4.3.5 Calculate the average of the 10 recorded force values, which is the
residual breaking strength.
4.4 Result calculation
Calculate the retention value of breaking strength according to Formula (1):
Where:
BSR -- Retention value of breaking strength;
F0 -- Initial breaking strength;
F1 -- Residual breaking strength.
......

BASIC DATA
Standard ID YY/T 1746-2020 (YY/T1746-2020)
Description (Translated English) Absorbable surgical suture -- Test method for breaking strength in vitro hydrolytic degradation
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 5,560
Date of Issue 2020-09-27
Date of Implementation 2021-09-01
Drafting Organization Shanghai Pudong Jinhuan Medical Products Co., Ltd., Shanghai Medical Device Testing Institute, Huaiyin Medical Device Co., Ltd., Jiangsu Medical Device Testing Institute
Administrative Organization National Technical Committee for Standardization of Surgical Instruments (SAC/TC 94)
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration