Powered by Google-Search & Google-Books Chinese Standards Shop Database: 169759 (Oct 25, 2020)
HOME   Quotation   Tax   Examples Standard-List   Contact-Us   View-Cart
  

YY/T 1555.1-2017

Chinese Standard: 'YY/T 1555.1-2017'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1555.1-2017English119 Add to Cart Days<=3 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
YY/T 1555.1-2017Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

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
Particular requirement of silicone gel filled breast implant-Performance requirement of silicone gel filler-Part 1. Limitation requirement of volatile substances
ICS 11.040.30
C30
People's Republic of China pharmaceutical industry standards
Silicon gel-filled breast implants specific requirements
Silicone gel filler performance requirements
Part 1. Limits of Volatile Substances
requirementofsiliconegelfiler-Part 1.Limitation
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Directory
Preface Ⅰ
1 range 1
2 Terms and definitions 1
3 samples and equipment 1
4 test methods 2
5 results calculated 2
6 limited requirements 2
Reference 3
Foreword
YY/T 1555 "Silicone-filled breast implant-specific requirements of silicone gel filler performance requirements" consists of two parts.
--- Part 1. Volatile substances limited requirements;
--- Part 2. Leachable substance limit requirements.
This part of YY/T 1555 Part 1.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part of the National Surgical Implant and Orthopedic Instruments Standardization Technical Committee (SAC/TC110) centralized.
This part of the drafting unit.China Food and Drug Inspection Institute, Hebei Province, Medical Devices and Pharmaceutical Packaging Materials Inspection Institute, the National Food
Drug Administration of Hubei Medical Devices Quality Supervision and Inspection Center.
This section participates in the drafting unit. Shanghai Corning Medical Products Co., Ltd., Shanghai Weining Plastic Products Co., Ltd., Guangzhou City, and plastic surgery
Materials Co., Ltd., Yuyao Jinsheng medical supplies plant.
The main drafters of this section. Fu Bufang, Wang Li, Wei Yan, Feng Xiaoming, Wang Chunren.
Silicon gel-filled breast implants specific requirements
Silicone gel filler performance requirements
Part 1. Limits of Volatile Substances
1 Scope
This section YY/T 1555 specifies silicone gel filled breast implants silicone gel filled with volatile substances detection methods and
Limited requirements.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Breast implants mammaryimplant
An implant with a housing for increasing the breast volume or replacing the breast can be filled by the manufacturer or surgeon into the housing
Fill the body.
[YY 0647-2008, Definition 3.5]
2.2
Volatile substances volatilesubstances
Heat at (150 ± 2) ° C for 4h to vaporize.
2.3
Filler filer
The contents of the implant.
2.4
Silicone gelgel
A class of low modulus gel materials composed of low cross-linked polysiloxanes.
3 samples and equipment
3.1 samples
Silicone gel filled breast implants.
3.2 equipment
3.2.1 thermostat blast drying oven.
3.2.2 electronic balance (precision 0.1mg).
3.2.3 weighing bottle (recommended diameter 60mm).
3.2.4 dryer.
Related standard:   YY/T 1555.2-2018  YY/T 1535-2017
Related PDF sample:   YY/T 1681-2019  YY/T 1630-2018
   
 
Privacy   ···   Product Quality   ···   About Us   ···   Refund Policy   ···   Fair Trading   ···   Quick Response
Field Test Asia Limited | Taxed in Singapore: 201302277C | Copyright 2012-2020