• ASTM F 2038 : 2000 : R2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-13-2019

    Language(s):  English

    Published date:  12-01-2011

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2015 Specifies the selection of appropriate materials, after consideration of the chemical, physical, and toxicological properties of individual ingredients or by-products.

    Scope - (Show below) - (Hide below)

    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.

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    Committee F 04
    Document Type Guide
    Product Note Reconfirmed 2011
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 703 : 2018 Standard Specification for Implantable Breast Prostheses
    ASTM F 2042 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    ASTM F 1781 : 2015 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
    ASTM F 1441 : 2003 : R2014 Standard Specification for Soft-Tissue Expander Devices

    Standards Referencing This Book - (Show below) - (Hide below)

    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
    AAMI ST30 : 1989 DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI ST29 : 1988 DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES
    ANSI/ISO/ASQ Q9001:2008 Quality Management Systems - Requirements
    ASTM D 1566 : 2015 : REDLINE TERMINOLOGY RELATING TO RUBBER
    AAMI TIR 8 : 1ED 91 MICROBIOLOGICAL METHODS FOR GAMMA IRRADIATION STERILIZATION OF MEDICAL DEVICES
    AAMI ISO TIR 13409 : 1996 ERRATA 2005 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE FOR SMALL OR INFREQUENT PRODUCTION BATCHES
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