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YY/T 1555.1-2017 English PDF

YY/T 1555.1-2017 (YY/T1555.1-2017, YYT 1555.1-2017, YYT1555.1-2017)
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YY/T 1555.1-2017English110 Add to Cart 0--9 seconds. Auto-delivery Particular requirement of silicone gel filled breast implant—Performance requirement of silicone gel filler—Part 1: Limitation requirement of volatile substances Valid YY/T 1555.1-2017
Standards related to: YY/T 1555.1-2017

BASIC DATA
Standard ID YY/T 1555.1-2017 (YY/T1555.1-2017)
Description (Translated English) Particular requirement of silicone gel filled breast implant--Performance requirement of silicone gel filler--Part 1: Limitation requirement of volatile substances
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 6,687
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Drafting Organization China Institute of Food and Drug Control, Hebei Province, Medical Devices and Pharmaceutical Packaging Materials Inspection Institute, the State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection Center
Administrative Organization National Surgical Implants and Orthopedic Instruments Standardization Technical Committee (SAC/TC 110)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 38
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

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; ...