ASTM F2042-00(2011)
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
- Standard No.
- ASTM F2042-00(2011)
- Release Date
- 2011
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2042-18
- Latest
- ASTM F2042-18
- Scope
- 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).
ASTM F2042-00(2011) Referenced Document
- ANSI/AAMI ST29 Recommended Practice for Determining Residual Ethylene Oxide in Medical Devices
- ANSI/AAMI ST30 Determining Residual Ethylene Chlorohydrin and Ethylene Glycol in Medical Devices
- ANSI/AAMI ST41
- ANSI/AAMI ST46
- ANSI/AAMI ST50
- ASTM D1349 Standard Practice for Rubber-Standard Temperatures for Testing
- ASTM D1566 Standard Terminology Relating to Rubber*， 2021-11-01 Update
- ASTM D2240 Standard Test Method for Properties of Rubber &8212; Durometer Hardness*， 2024-04-21 Update
- ASTM D395 Standard Test Methods for Rubber Property-Compression Set
- ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
- ASTM D430 Standard Test Methods for Rubber Deterioration-Dynamic Fatigue
- ASTM D624 Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers*， 2024-04-21 Update
- ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
- ASTM D813 Standard Test Method for Rubber Deterioration-Crack Growth
- ASTM D814 Standard Test Method for Rubber Property—Vapor Transmission of Volatile Liquids*， 2020-02-01 Update
- ASTM D926 Standard Test Method for Rubber Property-Plasticity and Recovery (Parallel Plate Method)
- ASTM D955 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
- ASTM F1905 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
- ASTM F1906 Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
- ASTM F1984 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials*， 2018-02-01 Update
- ASTM F2038 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials*， 2024-04-21 Update
- ASTM F619 Standard Practice for Extraction of Medical Plastics
- ASTM F719 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
- ASTM F720 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
ASTM F2042-00(2011) history
- 2018 ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
- 2011 ASTM F2042-00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
- 2005 ASTM F2042-00(2005) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
- 2000 ASTM F2042-00e1 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
- 2000 ASTM F2042-00 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
