YY/T 0818.1-2010Guide for silicone elastomers, gels and foams used in medical applications - Part 1: Formulation and uncured materials (English PDF)

Foreword

YY/T 0818 under the general title of "medical silicone elastomers, gels, foams Standard Guide", consists of the following components.

--- Part 1. Composition and uncured material;

--- Part 2. crosslinked and production. This section YY/T Section 10818 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

YY/T 0818 This section uses amend Part 1 of medical silicone elastomers, gels, foams Standard Guide ASTM F2038-00 " Score. Composition and uncured material. "

This section is drafted. Shandong Medical Devices Product Quality Inspection Center.

Introduction

A silicone elastomer medical devices are widely used in public health, and biologically safe for use in many applications history. This guide allows users to understand the formulation of such elastomers are the most primitive of the final instrument biocompatibility of. Silicone elastomers Production will also affect the final product biocompatibility, in Part 2 of this guide involves a silicone elastomer production.

This guide is divided into two parts, one on the recipe part involves production. Information (and further research in this guide provided Recommended) can be used as a user to find biological effects of silicone recipe guide. Manufacturer's responsibility to carry out standard in its industrial production quasi. Manufacturers can deviate in the implementation of standards, provided that the deviations provide the appropriate basis.

Biocompatible silicone elastomer problem can be divided into several levels, but the final equipment manufacturer to be based on the expected use of the instrument into Biological evaluation of the line.

When the material in accordance with recognized quality standards (such as GB/T 19001 and current regulations/Manufacturing Practice) production, its physical and biological properties Performance will be more reproducible.

1 Scope

YY/T 0818 This section is expected to be used to guide the user to grasp the composition and use of medical silicone elastomers, gels and foams. this Section does not provide information on silicone powders, liquids and other forms of silicone. This section provides information to guide the user Having considered each single component or a chemical, physical and toxicological properties of by-products, how to choose suitable materials. This section silicone material In a typical application in the field of medical material provides general information. Details of crosslinked silicone materials and production, see Part 2 of this specification.

Performance silicone rubber surgical implants and see YY 0334 YY 0484. This section relates only uncured elastomers, gels and foams Component.

This section does not involve the use of any safety issues. Users of this section has the responsibility to develop appropriate safety and health practices and Prior to use to determine the applicability of the relevant regulatory limits. Uncured silicone components, it recommends that users can refer to "Material Safety Data Sheet."

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB 18278 confirm sterilization of health care products and routine control of industrial moist heat sterilization

GB 18279 ethylene oxide sterilization of medical devices Validation and routine control

GB 18280 confirm sterilization of health care products and routine control of radiation sterilization

GB 19973.1 Sterilization of medical devices - Microbiological methods - Part 1. Product estimated the total number of microorganisms Requirements YY 0287 medical device quality management system for regulatory

YY 0334 silicone rubber surgical implants - General requirements

YY 0484 surgical implants bicomponent plus molding silicone rubber ASSI/AAMIST50 dry heat (hot air) sterilizers

3 Terms and Definitions

The following terms and definitions apply to this document.