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Significance and Use
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.
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, F2038 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).
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 Property--Compression Set
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D430 Test Methods for Rubber Deterioration--Dynamic 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 Property--Plasticity and Recovery (Parallel Plate Method)
D955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D1349 Practice for Rubber--Standard Temperatures for Testing
D1566 Terminology Relating to Rubber
D2240 Test Method for Rubber Property--Durometer Hardness
F619 Practice for Extraction of Medical Plastics
F719 Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
F720 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F1906 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation, and Cell Migration
F1984 Practice for Testing for Whole Complement Activation in Serum by Solid Materials
F2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I--Formulations and Uncured Materials
Quality Standards21CFR211 Current Good Manufacturing Practice for Finished Pharmaceuticals (current revision)
Other StandardsBiologicalPerformanc J. Black, Marcel Dekker, NY 1992
Other Biocompatibility StandardsHIMAMemorandum Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials, 7/14/93 Available from Advanced Medical Technology Association, 1200 G St. N.W. Suite 400 Washington, D.C. 20005-3814, http://www.advamed.org.
Sterilization StandardsAAMITIR8–251 Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
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)