YY/T 0818.2-2010Standard guide for organosilicone elastomers, gels and foams used in medical applications - Part 2: Crosslinking and fabrication (English PDF)
医用有机硅弹性体、凝胶、泡沫标准指南 第2部分：交联和制作
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY/T 0818.2-2010 is the English-translated version of 医用有机硅弹性体、凝胶、泡沫标准指南 第2部分：交联和制作.
YY/T 0818.2-2010 is the Chinese standard "Standard guide for organosilicone elastomers, gels and foams used in medical applications - Part 2: Crosslinking and fabrication".
Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY/T 0818.2-2010
National Standard of the People's Republic of China
- ICS
- 11.040.20
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 528Rubber, vulcanized or thermoplastic -- Determination of tensile stress-strain properties
- GB/T 529Rubber, vulcanized or thermoplastic -- Determination of tear strength (Trouser, angle and crescent test pieces)
- GB/T 531.1Rubber, vulcanized or thermoplastic -- Determination of indentation hardness -- Part 1: Durometer method (Shore hardness)
- GB/T 533Rubber, vulcanized or thermoplastic -- Determination of density
- GB/T 1688Rubber, vulcanized -- Determination of tension fatigue
- GB/T 12828Rubber, raw and unvalcanized compounded -- Determination of plasticity number and recovery number -- Parallel plate method
GB/T 7759 · GB/T 16886 · GB 18278 · GB 18280 · YY 0287
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Related Standards
GB 18278.1-2015 — Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 — Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18279-2023 — Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
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