YY/T 1555.1-2017Particular requirement of silicone gel filled breast implant-Performance requirement of silicone gel filler - Part 1: Limitation requirement of volatile substances (English PDF)

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.

3.1 Sample

Silicone gel filled breast implant.

3.2 Equipment

3.2.2 Electronic balance (accuracy of 0.1 mg).

3.2.3 Weighing bottle (the diameter is recommended to be 60 mm).

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.