YY/T 0818.1-2010 English PDFUS$279.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0818.1-2010: Guide for silicone elastomers, gels and forms used in medical applications. Part 1: Formulation and uncured materials Status: Valid
Basic dataStandard ID: YY/T 0818.1-2010 (YY/T0818.1-2010)Description (Translated English): Guide for silicone elastomers, gels and forms used in medical applications. Part 1: Formulation and uncured materials Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.20 Word Count Estimation: 12,149 Date of Issue: 2010-12-27 Date of Implementation: 2012-06-01 Quoted Standard: GB 18278; GB 18279; GB 18280; GB 19973.1; YY 0287; YY 0334; YY 0484; ASSI/AAMI ST 50 Adopted Standard: ASTM F2038-2000, 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 guide the user to grasp medical silicone elastomer gel and foam composition and use. This section does not provide silicone powders, liquids, and other forms of information silicones. The information provided in this section to guide the user through each single component or considering byproduct of the chemical, physical and toxicological properties, how to choose the appropriate material. This section of silicone materials in the medical field typical application provides a common message. Crosslinked silicone materials and production details, see Part 2 of this specification. Silastic implant surgery performance figures and see YY 0334 YY 0484. This section relates only uncured elastomers, gels and foams. This section does not involve the use of any security problems. This part of the responsibility of the user to establish appropriate safety and health practices and determine the relevant laws and regulations restrict the use of applicability. Uncured silicone component, the user can refer to (Material Safety Data Sheet). YY/T 0818.1-2010: Guide for silicone elastomers, gels and forms used in medical applications. Part 1: Formulation and uncured materials---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 1. Formulation and uncured materials ICS 11.040.20 C31 People's Republic of China pharmaceutical industry standards Medical silicone elastomers, gels, foams Standard Guide Part 1. Composition and uncured material Guideforsiliconeelastomers, gelsandformsusedinmedicalapplications- Part 1. Formulationanduncuredmaterials Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued ForewordYY/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 ASTMF2038-00 " Score. Composition and uncured material. " This section is proposed and managed by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This section is drafted. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this section. Shi Yanping, Zhang Limei, Wu Ping.IntroductionA 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. Medical silicone elastomers, gels, foams Standard Guide Part 1. Composition and uncured material1 ScopeYY/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 referencesThe 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) sterilizers3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 Silicone polymer siliconepolymer The main chain of the polymer containing repeating silicon and oxygen atoms, each silicon atom connecting two organic groups, the organic group is typically methyl, But it might be a vinyl, phenyl, fluoro or other organic group. 3.2 Cyclic and linear cyclicsandlinears D represents the molecular weight with a variable cyclic siloxane Si-O structural units (usually D4-D20); D7-D40 (or more) may be referred to "Macrocycle." According to chain length, the linear polymer may be variable or linear polymer having a high molecular weight; with M and D together represent, M is R3Si-O, D as described above; R & lt typically methyl. [E.g., MDM as (CH3) 3SiOSi (CH3) 2OSi (CH3) 3] and by processing Case of different silicone components of varying degrees, there is a low-molecular weight polymers, can be used according to the conditions, by vacuum, heat release or two ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0818.1-2010_English be delivered?Answer: Upon your order, we will start to translate YY/T 0818.1-2010_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0818.1-2010_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0818.1-2010_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
