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YY/T 1471-2016 English PDF

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YY/T 1471-2016: Requirements and tests for indomethacin rubber used for Cu-IUD
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PDF similar to YY/T 1471-2016


Standard similar to YY/T 1471-2016

YY/T 1704.1   YY/T 1704.2   YY/T 1470   

Basic data

Standard ID YY/T 1471-2016 (YY/T1471-2016)
Description (Translated English) Requirements and tests for indomethacin rubber used for Cu-IUD
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Classification of International Standard 11.200
Word Count Estimation 10,143
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB/T 528-2009; GB/T 529-2008; GB/T 531.1-2008; YY 0334-2002
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the materials, requirements, test methods and storage of indomethacin-containing silicone rubber (hereinafter referred to as indomethacin silicone rubber) containing copper IUD. This standard applies to the use of copper containing IUDs containing indomethacin silicone rubber.

YY/T 1471-2016: Requirements and tests for indomethacin rubber used for Cu-IUD

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Requirements and tests for indomethacin rubber used for Cu-IUD ICS 11.200 C36 People's Republic of China Pharmaceutical Industry Standard Containing Indomethacin Silicone Rubber for Copper IUD Requirements and test methods 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this standard may involve patents. The release of this standard The Agency does not assume responsibility for identifying these patents. This standard is proposed and centralized by the National Standardization Technical Committee for Family Planning Instruments (SAC/TC169). The drafting of the standard units. Shanghai Medical Devices Testing Institute, Yantai Family Planning and Pharmaceutical Co., Ltd. The main drafters of this standard. Yao Tianping, Zou Fengping, Xu Jingduo, Tian Yunxia. Containing Indomethacin Silicone Rubber for Copper IUD Requirements and test methods

1 Scope

This standard specifies the material containing indomethacin silicone rubber (hereinafter referred to as indomethacin silicone rubber) containing copper IUD, requiring that the test Methods and storage. This standard applies to the use of copper containing IUDs containing indomethacin silicone rubber.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Rubber, vulcanized or thermoplastic elastomers - Determination of tensile stress - strain properties GB/T GB/T 529-2008 Determination of tear strength of vulcanized rubber or thermoplastic rubber (pants, right angle and crescent specimens) GB/T 531.1-2008 Vulcanized rubber or thermoplastic rubber - Test method for hardness - Part 1. Shore 's hardness method (Shao Hardness) General requirements for silicone rubber surgical implants YY 0334-2002 Pharmacopoeia of the People's Republic of China (2015)

3 material

3.1 indomethacin silicone rubber from the indomethacin raw materials loaded in the silicone rubber mixing, curing from. 3.2 Indomethacin API [Chemical name. 2-methyl-1- (4-chlorobenzoyl) -5-methoxy-1H-indole-3-acetic acid] should meet the "Chinese The Republic of China Pharmacopoeia (two) "(2015 edition) requirements. 3.3 silicone rubber should meet the requirements of YY 0334-2002. Note. The biological evaluation of indomethacin silicone rubber is carried out in conjunction with the biological evaluation of the final product of copper-containing IUD.

4 requirements

4.1 Surface quality Indomethacin silicone rubber color should be milky white or yellowish, the outer surface should be no bubbles, no impurities and foreign particles. 4.2 Physical properties of indomethacin silicone rubber The physical properties of the indomethacin silicone rubber shall be in accordance with Table 1.

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