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YY/T 0818.2-2010 English PDF

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YY/T 0818.2-2010: Guide for silicone elastomers, gels and forms used in medical applications. Part 2: Crosslinking and fabrication
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YY/T 0818.2-2010English329 Add to Cart 3 days [Need to translate] Guide for silicone elastomers, gels and forms used in medical applications. Part 2: Crosslinking and fabrication Valid YY/T 0818.2-2010

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Basic data

Standard ID YY/T 0818.2-2010 (YY/T0818.2-2010)
Description (Translated English) Guide for silicone elastomers, gels and forms used in medical applications. Part 2: Crosslinking and fabrication
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 14,158
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard GB/T 528; GB/T 529; GB/T 531.1; GB/T 533; GB/T 1688; GB/T 2941; GB/T 7759; GB/T 12828; GB/T 16175; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.8; GB/T 16886.9; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17; GB/T 16886.18; GB/T 16886.19; GB/T 17037.4-2003; GB 18278; GB 18279; GB 18280; GB 19973.1; YY 0287; YY 0334; YY 0484; ASSI/AAMI ST 50
Adopted Standard ASTM F2042-2000, MOD
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to guidance silicone elastomer gel and foam production and processing. This section does not provide silicone powder, liquid, pressure or other types of silicone products related information. The information provided in this section are used to guide the user to select the appropriate conditions to process a particular purpose medical devices. Part 1 of this section, including formulations and appropriate selection of raw materials. This section only relates to silicone elastomers, gels and foam curing, post cured and processed, and how to evaluate the product.

YY/T 0818.2-2010: Guide for silicone elastomers, gels and forms used in medical applications. Part 2: Crosslinking and fabrication


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Guide for silicone elastomers, gels and forms used in medical applications.Part 2. Crosslinking and fabrication ICS 11.040.20 C31 People's Republic of China Pharmaceutical Industry Standard Standard Guide for Medical Silicone Elastomers, Gels, Foams Part 2. Crosslinking and production Guideforsiliconeelastomers, gelsandformsusedinmedicalapplications- Part 2. Crosslinkingandfabrication 2010-12-27 release 2012-06-01 implementation State Food and Drug Administration issued

Foreword

YY/T 0818, entitled "Medical Silicone Elastomer, Gel, Foam Standard Guide", consists of the following. Part 1. Composition and uncured materials; Part 2. Crosslinking and production. This part is part 2 of YY/T 0818. This part is drafted in accordance with the rules given in GB/T 1.1-2009. YY/T 0818 This part is modified using ASTM F2042-00 "Medical Silicone Elastomer, Gel, Foam Standard Guide Part 2 Points. cross-linking and production ". This part of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center proposed and centralized. This part of the drafting unit. Shandong Province, medical equipment product quality inspection center, Shandong 100 more than medical equipment Limited. This part of the main drafters. Shi Yanping, Zhang Limei, Wu Ping.

Introduction

Medical devices made from silicone elastomers are widely used in public health care and have a biosafety use in many applications history. This guide allows the user to understand that the formulation of such elastomers is the most primitive impact on the final instrument biocompatibility. Silicone elastomer Production will also have an impact on the biocompatibility of the final product, and the second part of this standard deals with the production of silicone elastomers. The standard is divided into two parts, one part involving the formula, part of the production involved. The information provided by this standard (and further research) Recommended) as a guide for users to find the biological effects of silicone formulations. The manufacturer's responsibility is to carry out the standard in its industrial production quasi. The manufacturer may deviate from the implementation of the standard, provided that the deviation is provided with the appropriate basis. The biocompatibility of silicone elastomers can be divided into several levels, but the manufacturer of the final instrument is required to use the intended use of the device Line biology evaluation. When the material is produced according to recognized quality standards (eg GB/T 19001 and current regulations/production management practices), its biological properties and physical Performance will be more reproducible. Standard Guide for Medical Silicone Elastomers, Gels, Foams Part 2. Crosslinking and production

1 Scope

This part of YY/T 0818 is intended for use in the manufacture and processing of silicone elastomers, gels and foams. This section does not provide organic Silicon powder, liquid, pressure sensitive adhesive or other types of silicone products. The information provided in this section is used to guide the user to select the appropriate conditions for the processing of a particular use of medical devices. Part 1 of this section includes the selection of recipes and suitable raw materials. This section deals only with silicone elastomers, gels and foams The second stage of vulcanization and processing, and how to evaluate the finished product.

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. GB/T 528 vulcanized rubber or thermoplastic rubber tensile stress and strain properties of the determination GB/T 529 Determination of tear strength of vulcanized rubber or thermoplastic rubber (pants, right angle and crescent specimens) GB/T 531.1 vulcanized rubber or thermoplastic rubber press hardness test method Part 1. Shore hardness tester (Shore hardness) GB/T 533 Determination of vulcanized rubber or thermoplastic rubber density GB/T 1688 Determination of tensile fatigue of vulcanized rubber Rubber - Physical test methods - General procedures for the preparation and adjustment of specimens GB/T GB/T 7759 vulcanized rubber, thermoplastic rubber at room temperature, high temperature and low temperature compression set GB/T 12828 Rubber and unvulcanization - Determination of plasticity and recovery values - Parallel plate method GB/T Test method for biological evaluation of medical organosilicon materials GB/T GB/T 16886 Biological evaluation of medical devices (all parts) GB/T 17037.4-2003 Plastics - Thermoplastic materials - Preparation of injection molded specimens - Part 4. Determination of molding shrinkage GB 18278 Sterilization of medical and health care products and routine control requirements Industrial damp heat sterilization GB 18279 Sterilization and routine control of ethylene oxide sterilization in medical devices GB 18280 Sterilization of medical and health care products and routine control requirements for radiation sterilization GB.19973.1 Methods for sterilization of medical devices - Part 1. Estimates of total microbes of products YY 0287 medical device quality management system for regulatory requirements General requirements for silicone rubber surgical implants YY 0334 YY 0484 foreign material implants two - component addition vulcanized silicone rubber ASSI/AAMIST50 dry heat (hot air) sterilizer

3 terms and definitions

The following terms and definitions apply to this document.

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