YY/T 1555.2-2018: Particular requirements for the silicone gel filled breast implant - Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances

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Scope

This Part of YY/T 1555 specifies the extraction methods, detection methods and
limit requirements for extractable substances in the silicone gel filler used for
artificial mammary implant.
This Part applies to artificial mammary implants with silicone gel as the inner
filler.

Basic Data

Standard ID	YY/T 1555.2-2018 (YY/T1555.2-2018)
Description (Translated English)	Particular requirements for the silicone gel filled breast implant - Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.30
Word Count Estimation	9,966
Date of Issue	2018-12-20
Date of Implementation	2020-01-01
Quoted Standard	YY 0334-2002; YY/T 1457
Regulation (derived from)	State Drug Administration Announcement No. 97 of 2018
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the extraction method, detection method and limit requirements for extractable substances in silicone gel fillings for artificial breast implants. This standard applies to artificial breast implants with silicone gel as the inner filling.