1. Scope

1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids, and other silicones. The information provided is offered to guide users in the selection of appropriate materials, after consideration of the chemical, physical and toxicological properties of individual ingredients or by-products. This standard offers general information about silicone materials typically used for medical applications. Detail on the crosslinking and fabrication of silicone materials is found in Part II of this standard.

1.2 Fabrication and properties of elastomers is covered in the companion document, F604, Part II. This monograph addresses only components of uncured elastomers, gels and foams.

1.3 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Users are also advised to refer to Material Safety Data Sheets provided with uncured silicone components.

1.5 Biological and physical properties tend to be more reproducible when materials are manufactured in accordance with accepted quality standards such as ANSI ISO 9001 and current FDA Quality System Regulations/Good Manufacturing Practice Regulations.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D1566 Terminology Relating to Rubber

F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

Sterility Standards

Quality Standards

Keywords

elastomer; foam; gel; HCR; high consistency rubber; liquid silicone rubber; LSR; moisture cure; medical device material; peroxide cure; platinum cure; RTV; Medical materials/applications--specifications; Orthopaedic medical devices--specifications; Silicone surgical implant materials; Surgical implants--specifications; Uncured elastomeric materials

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2038-00E01

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