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ASTM F2042-00(2005)

(Guide)

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication

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.
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, 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 Information

Status
Historical
Publication Date
28-Feb-2005
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F2042-00e1 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
Effective Date
01-Mar-2005
Replaced By
ASTM F2042-00(2011) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
Effective Date
01-Dec-2011
Referred By
ASTM F2038-18 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
Effective Date
01-Mar-2005
Referred By
ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
Effective Date
01-Mar-2005
Referred By
ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Mar-2005
Referred By
ASTM F703-18(2022) - Standard Specification for Implantable Breast Prostheses
Effective Date
01-Mar-2005

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ASTM F2042-00(2005) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and FabricationASTM F2042-00(2005) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
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ASTM F2042-00(2005) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2042 – 00 (Reapproved 2005)
Standard Guide for
Silicone Elastomers, Gels, and Foams Used in Medical
1
Applications Part II—Crosslinking and Fabrication
This standard is issued under the fixed designation F2042; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope plastic Elastomers—Tension
D430 Test Methods for Rubber Deterioration—Dynamic
1.1 This guide is intended to educate potential users of
Fatigue
silicone elastomers, gels and foams relative to their fabrication
D624 Test Method for Tear Strength of Conventional Vul-
and processing. It does not provide information relative to
canized Rubber and Thermoplastic Elastomers
silicone powders, fluids, pressure sensitive adhesives, or other
D792 Test Methods for Density and Specific Gravity (Rela-
types of silicone products.
tive Density) of Plastics by Displacement
1.2 Theinformationprovidedisofferedtoguideusersinthe
D813 Test Method for Rubber Deterioration—Crack
selection of appropriate processing conditions for specific
Growth
medical device applications.
D814 Test Method for Rubber Property—Vapor Transmis-
1.3 Formulation and selection of appropriate starting mate-
sion of Volatile Liquids
rials is covered in the companion document, F2038 Part I.This
D926 Test Method for Rubber Property—Plasticity and
monograph addresses only the curing, post-curing, and pro-
Recovery (Parallel Plate Method)
cessing of elastomers, gels and foams as well as how the
D955 Test Method of Measuring Shrinkage from Mold
resulting product is evaluated.
Dimensions of Thermoplastics
1.4 Silicone biocompatibility issues can be addressed at
D1349 Practice for Rubber—Standard Temperatures for
several levels, but ultimately the device manufacturer must
Testing
assess biological suitability relative to intended use. Biocom-
D1566 Terminology Relating to Rubber
patibilitytestingmaybedoneoncuredelastomerspriortofinal
D2240 Test Method for Rubber Property—Durometer
fabrication,butthemostrelevantdataarethoseobtainedonthe
Hardness
finished device. Data on selected lots of material are only
F619 Practice for Extraction of Medical Plastics
representative when compounding, and fabrication are per-
F719 Practice for Testing Biomaterials in Rabbits for Pri-
formed under accepted quality systems such as ISO 9001 and
mary Skin Irritation
current Good Manufacturing Practice Regulations. Extract-
F720 Practice for Testing Guinea Pigs for Contact Aller-
ables analyses may also be of interest for investigation of
gens: Guinea Pig Maximization Test
biocompatibility, and the procedures for obtaining such data
F748 Practice for Selecting Generic Biological Test Meth-
depend on the goal of the study (see F619, the HIMA
ods for Materials and Devices
Memorandum 7/14/93, and USP23, for examples of extraction
F813 Practice for Direct Contact Cell Culture Evaluation of
methods).
Materials for Medical Devices
2. Referenced Documents
F981 Practice forAssessment of Compatibility of Biomate-
2
rials for Surgical Implants with Respect to Effect of
2.1 ASTM Standards:
Materials on Muscle and Bone
D395 TestMethodsforRubberProperty—CompressionSet
F1905 Practice For Selecting Tests for Determining the
D412 Test Methods for Vulcanized Rubber and Thermo-
Propensity of Materials to Cause Immunotoxicity
F1906 Practice for Evaluation of Immune Responses In
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Biocompatibility Testing Using ELISATests, Lymphocyte
Surgical Materials and Devices and is the direct responsibility of Subcommittee
Proliferation, and Cell Migration
F4.11 on Polymeric Materials.
F1984 Practice for Testing for Whole Complement Activa-
Current edition approved Mar. 1, 2005. Published March 2005. Originally
´1
tion in Serum by Solid Materials
approved in 2000. Last previous edition approved in 2000 as F2042 – 00 . DOI:
10.1520/F2042-00R05.
F2038 Guide for Silicone Elastomers, Gels, and Foams
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Used in Medical Applications Part I—Formulations and
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Uncured Materials
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2042 – 00 (2005)
2.2 Other Biocompatibility Standards: Biological Performance of Materials: J. Black, Marcel De-
United States Pharmacopeia, current edition (appropriate kker, NY 1992
3
...

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1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
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SCOPE
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A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
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1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
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ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the 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.  
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.

  • Guide
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    English language
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  • Guide
    8 pages
    English language
    sale 15% off