YY/T 1555.1-2017 English PDF (YYT1555.1-2017)

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YY/T 1555.1-2017: Particular requirement of silicone gel filled breast implant—Performance requirement of silicone gel filler—Part 1: Limitation requirement of volatile substances
YY/T 1555.1-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 30
Particular requirement of silicone gel filled breast
implant - Performance requirement of silicone gel filler
- Part 1: Limitation requirement of volatile substances
ISSUED ON: MARCH 28, 2017
IMPLEMENTED ON: APRIL 01, 2018
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Terms and definitions ... 4 
3 Samples and equipment ... 5 
4 Test method ... 5 
5 Result calculation ... 5 
6 Limit requirements ... 6 
References ... 7 
Particular requirement of silicone gel filled breast
implant - Performance requirement of silicone gel filler
- Part 1: Limitation requirement of volatile substances
1 Scope
This part of YY/T 1555 specifies the detection methods and limit requirements
of volatile substances in silicone gel filler of silicone gel filled breast implant.
2 Terms and definitions
The following terms and definitions are applicable to this document.
2.1
mammary implant
An implant with a shell, which is used for increasing the volume of the breast or
replacing the breast. The shell can be filled with objects by a manufacturer or a
surgeon.
[YY 0647-2008, definition 3.5]
2.2
volatile substances
Substances that can be vaporized by heating at (150±2) °C for 4 h.
2.3
filler
The contents of the implant.
2.4
silicone gel
A type of low-modulus gel material that is composed of low-degree cross-linked
polysiloxane.
3 Samples and equipment
3.1 Sample
Silicone gel filled breast implant.
3.2 Equipment
3.2.1 Constant temperature blast drying oven.
3.2.2 Electronic balance (accuracy of 0.1 mg).
3.2.3 Weighing bottle (the diameter is recommended to be 60 mm).
3.2.4 Desiccator.
4 Test method
4.1 Principle
Heat the silicone gel sample at a certain temperature; calculate the percentage
of mass loss of the sample after heating accounting for the initial mass of the
sample, which is the mass fraction of the volatile substances of the silicone gel.
4.2 Test procedure
Take 2 g ~ 3 g of silicone gel sample; spread it in a weighing bottle, with a
diameter of about 60 mm, that has been dried to constant weight (m0) in a
constant temperature blast drying oven at (150±2) °C; weigh (m1), accurate to
0.000 1 g; place it in a constant temperature blast drying oven at (150±2) °C to
heat for 4 h; then, take it out and place it in a desiccator to cool to room
temperature; weigh it (m2). Test two samples in parallel. The results are
expressed as the average of the results of the two parallel samples.
Note: Refer to ASTM F703-07 for the test procedure.
5 Result calculation
Calculate the mass fraction ρ of silicone gel volatile substances as follows:
Where:
ρ – the mass fraction of silicone gel volatile substances;