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YY/T 1555.2-2018

Chinese Standard: 'YY/T 1555.2-2018'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1555.2-2018Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  
YY/T 1555.2-2018English159 Add to Cart Days<=3 Particular requirements for the silicone gel filled breast implant. Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances Valid YY/T 1555.2-2018

   

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 & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 9,998
Date of Issue 2018-12-20
Date of Implementation 2020-01-01
Quoted Standard YY 0334-2002; YY/T 1457
Drafting Organization China Institute of Food and Drug test
Administrative Organization National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices
Regulation (derived from) State Drug Administration Announcement No. 97 of 2018
Proposing organization State Drug Administration
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.

YY/T 1555.2-2018
(Silicone-filled breast implants - Particular requirements for silicone gel fillings - Part 2. Limits for extractable substances)
ICS 11.040.30
C30
People's Republic of China Pharmaceutical Industry Standard
Silicone gel filled breast implant special requirements
Silicone gel filling performance requirements
Part 2. Limit requirements for extractable substances
Part 2. Limitsrequirementforextractablesubstances
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Foreword
YY/T 1555 "Silicone-filled breast implants require silicone gel filler performance requirements" consists of two parts.
--- Part 1. Limitation requirements for volatile substances;
--- Part 2. Limit requirements for extractable substances.
This part is the second part of YY/T 1555.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This section drafted by. China Food and Drug Control Institute, Hebei Province Medical Devices and Pharmaceutical Packaging Materials Inspection Institute, Huainan City
Food and Drug Testing Center, Shenzhen Drug Testing Institute (Shenzhen Medical Device Testing Center), Xi'an Petroleum University.
The main drafters of this section. Fu Bufang, Wang Li, Wang Kun, Cao Ping, Lin Chunling, Peng Jun, Feng Xiaoming, Wang Chunren.
Silicone gel filled breast implant special requirements
Silicone gel filling performance requirements
Part 2. Limit requirements for extractable substances
1 Scope
This part of YY/T 1555 specifies the extraction method and detection of extractable substances in silicone gel fillings for artificial breast implants.
Method and limit requirements.
This section applies to artificial breast implants with silicone gel as the inner filling.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this standard.
YY 0334-2002 General requirements for silicone rubber surgical implants
YY/T 1457 passive surgical implants - Determination of oligosiloxanes in breast implants
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Breast implant mammaryimplant
An implant with a housing for increasing breast volume or replacing a breast, which can be filled by the manufacturer or surgeon into the housing
Fill the object.
[YY 0647-2008, definition 3.5]
3.2
Filler filer
The contents of the implant.
3.3
Silicone silicone
A class of low modulus gel materials composed of low crosslinked polysiloxanes.
3.4
Extractable substance extractingsubstances
Substance immersed from the silicone gel under the specified leaching conditions with a suitable solvent.
4 Limited requirements
4.1 pH
The absolute value of the difference between the pH of the sample aqueous extract and the blank control solution should be no more than 1.5.
Related standard:   YY/T 1555.1-2017  YY/T 1535-2017
Related PDF sample:   YY/T 1681-2019  YY/T 1630-2018
   
 
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