YY/T 1457-2016: Non-active surgical implants - Determination method for oligomeric siloxanes in mammary implants

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Scope

This Standard specifies the gas chromatograph-mass spectrometer (GC/MS)
qualitative and quantitative test methods for oligomeric siloxanes in the silicone
elastomer shell and silicone gel filler of mammary implants.
In addition to the method selected in this Standard, other equivalent methods may also
be adopted, but appropriate methodological verification is required.

Basic Data

Standard ID	YY/T 1457-2016 (YY/T1457-2016)
Description (Translated English)	Non-active surgical implants - Determination method for oligomeric siloxanes in mammary implants
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	10,173
Date of Issue	2016-01-26
Date of Implementation	2017-01-01
Regulation (derived from)	China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)	State Food and Drug Administration