YY/T 0818.1-2010 (English Version) PDF

Scope: This part of YY/T 0818 is intended to guide users on 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 in selecting appropriate materials after considering the chemical, physical and toxicological properties of individual components or by-products. This section provides general information on typical applications of silicone materials in the medical field. Details of cross-linking and fabrication of silicone materials are found in Part 2 of this specification. The properties of silicone rubber surgical implants are also described in YY 0334 and YY 0484. This section deals only with the components of uncured elastomers, gels and foams. This section does not cover any safety aspects of use. It is the responsibility of the user of this section to establish appropriate safety and health practices and to determine the applicability of relevant regulatory limitations prior to use. For uncured silicone components, it is recommended that users also refer to the Material Safety Data Sheet.

YY/T 0818.1-2010 Referenced Document

GB 18278 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
GB 18279 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization*， 2023-09-08 Update
GB 18280 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
GB/T 19973.1 Microbiological methods for sterilization of healthcare products - Part 1: Determination of the total number of microorganisms on products*， 2023-03-17 Update
YY 0334 General specification for surgical implants made of silicone elastomer
YY 0484 Implants for surgery-Two-part addition-cure silicone elastomers

2010 YY/T 0818.1-2010 Guide for silicone elastomers, gels and forms used in medical applications.Part 1：Formulation and uncured materials