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Significance and Use
4.1 This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties.
4.2 Silicone manufacturers supplying material to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly or through the US FDA Master File program.
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, . 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 (21 CFR, Parts 210, 211, and 820). 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 ISO 10993–12 and the HIMA Memorandum 7/14/93 for examples of extraction methods).
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound 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, health, and environmental 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.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D395 Test Methods for Rubber PropertyCompression Set
D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
D430 Test Methods for Rubber DeteriorationDynamic Fatigue
D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D813 Test Method for Rubber Deterioration--Crack Growth
D814 Test Method for Rubber Property--Vapor Transmission of Volatile Liquids
D926 Test Method for Rubber PropertyPlasticity and Recovery (Parallel Plate Method)
D955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D1349 Practice for Rubber--Standard Conditions for Testing
D1566 Terminology Relating to Rubber
D2240 Test Method for Rubber PropertyDurometer Hardness
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part IFormulations and Uncured Materials
Sterilization StandardsANSI/AAMI ST50 Dry Heat (Heated Air) Sterilizers ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Other Biocompatibility StandardsFDA Guidance on Use of International Standard ISO 10993-1, Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management processGuidance for Industry and Food and Drug Administration Staff Available from Food and Drug Administration (FDA), 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, http://www.fda.gov.
Quality Standards21 CFR 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs: General 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR 820 Quality System Regulation Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://dodssp.daps.dla.mil. ISO9001 Quality Management SystemsRequirements
Other StandardsDow Corning CTM 0155 (Gel-Like Materials With Modified Penetrometer) Dow Corning CTM 0813 (Gel-Like Materials With One Inch Diameter Head Penetrometer) PCB Test Methods such as those used for MRI Project No. 4473, Jan 24, 1997 Available from Midwest Research Institute, 425 Volker Blvd., Kansas City, MO 641102299, Ph: (816) 753-7600.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 13111303(Silicone foam); 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
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ASTM F2042-18, Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top