• ASTM F 2042 : 2000 : EDT 1

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 II - Crosslinking and Fabrication

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-11-2014

    Language(s):  English

    Published date:  07-10-2000

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2015 Provides potential users of silicone elastomers, gels and foams relative to their fabrication and processing.

    Scope - (Show below) - (Hide below)

    1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone powders, fluids, pressure sensitive adhesives, or other types of silicone products.

    1.2 The information provided is offered to guide users in the selection of appropriate processing conditions for specific medical device applications.

    1.3 Formulation and selection of appropriate starting materials is covered in the companion document, F 2038 Part I. This monograph addresses only the curing, post-curing, and processing of elastomers, gels and foams as well as how the resulting product is evaluated.

    1.4 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use. Biocompatibility testing may be done on cured elastomers prior to final fabrication, but the most relevant data are those obtained on the finished device. Data on selected lots of material are only representative when compounding, and fabrication are performed under accepted quality systems such as ISO 9001 and current Good Manufacturing Practice Regulations. Extractables analyses may also be of interest for investigation of biocompatibility, and the procedures for obtaining such data depend on the goal of the study (see F619, the HIMA Memorandum 7/14/93, and USP 23, for examples of extraction methods).

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Guide
    Product Note Reconfirmed EDT 1
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ASTM F 1781 : 2015 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
    ASTM F 703 : 2018 Standard Specification for Implantable Breast Prostheses
    ASTM F 2038 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
    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
    ASTM D 926 : 2017 : REDLINE Standard Test Method for Rubber Property—Plasticity and Recovery (Parallel Plate Method)
    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 ST46 : 4ED 2002 STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    ASTM D 1349 : 2014 : REDLINE Standard Practice for Rubber—Standard Conditions for Testing
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    AAMI ST29 : 1988 DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES
    ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ASTM F 720 : 2017 : REDLINE Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
    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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