ASTM F604-94
Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)

Standard No.

ASTM F604-94

Release Date

2017

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F604-94

Scope

1.1 This specification covers silicone elastomers intended for use as materials of construction for fabrication of medical devices. 1.2 Variations in ingredients, processing, and vulcanization (crosslinking/cure) systems of silicone elastomer are necessary to achieve the properties required in specific medical device applications. 1.2.1 An alphabetical/numerical code abbreviation is defined in this specification as what may be used to specify ingredients, crosslinking systems, processing conditions, and physical properties of many silicone elastomers used in medical device applications by a standard, abbreviated designation. 1.3 In all cases where the provisions of this specification are in conflict with those of the detailed specifications for a particular product, the latter shall take precedence. 1.3.1 When silicone elastomers are used in medical device applications where the materials requirements cannot be completely achieved by the technology prescribed in this specification, it may be necessary to adjust ingredients, processing, or cure systems to a greater extent to obtain the properties needed in these specific medical device applications. 1.3.1.1 When silicone elastomers are adjusted more extensively than prescribed in this specification, such adjustments shall be completely described and controlled in specifications for each specific material. 1.3.1.2 All sections of this specification that contain requirements pertinent to safety and effectiveness apply to all silicone elastomers used as materials of construction for medical devices, including those adjusted more broadly than defined in this specification. 1.4 While silicone elastomers have demonstrated excellent biocompatibility in medical device applications, the biocompatibility of silicone elastomers as a generic class has not been established. Many compositions and formulations are possible. Manufacturing practices, facilities, controls, process validation, and other considerations that ensure batch-to-batch duplication, assurance of identity, and quality of ingredients, as well as freedom from contamination or cross-contamination may vary widely within the silicone elastomer industry. Medical device manufacturers must ensure safety and effectiveness of each specific composition or formulation from each supplier in its intended applications. Historic, clinical, and biocompatibility data are pertinent prospectively only when all compounding, formulating, and fabrication are done in accordance with the provisions of Good Manufacturing Practice Regulations, which help ensure medical materials and devices are reasonably duplicated each time they are manufactured. 1.5 This specification is intended to assist in the development of specifications for formulated silicone elastomer compounds. It is also recommended for use in materials and finished device labeling to specify the type or types of silicone elastomers contained. 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.

ASTM F604-94 Referenced Document

• ASTM D1349 Standard Practice for Rubber-Standard Temperatures for Testing
• ASTM D1418 Standard Practice for Rubber and Rubber Latices-Nomenclature
• ASTM D149 Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
• ASTM D150 Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
• ASTM D1566 Standard Terminology Relating to Rubber*， 2021-11-01 Update
• ASTM D1898 
• ASTM D2240 Standard Test Method for Properties of Rubber &8212; Durometer Hardness*， 2024-04-21 Update
• ASTM D257 Standard Test Methods for DC Resistance or Conductance of Insulating Materials
• ASTM D3137 Standard Test Method for Rubber Property—Hydrolytic Stability*， 2018-08-01 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 D570 Standard Test Method for Water Absorption of Plastics*， 2018-08-01 Update
• 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 D865 Standard Test Method for Rubber-Deterioration by Heating in Air (Test Tube Enclosure)
• 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 D991 Standard Test Method for Rubber Property—Volume Resistivity Of Electrically Conductive and Antistatic Products*， 2020-02-01 Update
• ASTM F1251 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
• ASTM F619 Standard Practice for Extraction of Medical Plastics
• 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 F604-94 history

• 2017 ASTM F604-94 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)