ASTM-F2038 2011

$40.63

F2038-00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part Iâ€”Formulations and Uncured Materials

Published By	Publication Date	Number of Pages
ASTM	2011	5

Guaranteed Safe Checkout

Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

ASTM F2038-00-Reapproved2011

Historical Standard: Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

ASTM F2038

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 guide 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 guide.

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 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.

1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

1.6 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.

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/F2038-00R11

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
3	Significance and Use Formulation FIG. 1 FIG. 2
4	Packaging, Labeling, and Storage Health and Safety Sterilization Quality Control Provisions
5	Keywords X1. RATIONALE X1.1 X1.2

Additional information

Standard Title	F2038-00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part Iâ€”Formulations and Uncured Materials
Published Code	ASTM
Publication Date	2011
Pages Count	5
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics