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ASTM F2042-00e1

(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

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
09-Jul-2000
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 F2042-00 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
Effective Date
10-Jul-2000
Replaced By
ASTM F2042-00(2005) - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
Effective Date
01-Mar-2005
Referred By
ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
Effective Date
10-Jul-2000
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
10-Jul-2000
Referred By
ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
10-Jul-2000
Referred By
ASTM F703-18(2022) - Standard Specification for Implantable Breast Prostheses
Effective Date
10-Jul-2000

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ASTM F2042-00e1 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and FabricationASTM F2042-00e1 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
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ASTM F2042-00e1 - 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
e1
Designation:F2042–00
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 F 2042; 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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Figs. 1-3 and Figs. 5-9 were editorially revised in June 2001.
1. Scope D 430 Test Methods for Rubber Deterioration—Dynamic
2
Fatigue
1.1 This guide is intended to educate potential users of
D 624 Test Method for Tear Strength of Conventional
silicone elastomers, gels and foams relative to their fabrication
2
Vulcanized Rubber and Thermoplastic Elastomers
and processing. It does not provide information relative to
D 792 Test Methods for Specific Gravity (Relative Density)
silicone powders, fluids, pressure sensitive adhesives, or other
3
and Density of Plastics by Displacement
types of silicone products.
D 813 Test Method for Rubber Deterioration—Crack
1.2 Theinformationprovidedisofferedtoguideusersinthe
2
Growth
selection of appropriate processing conditions for specific
D 814 Test Method for Rubber Property—Vapor Transmis-
medical device applications.
2
sion of Volatile Liquids
1.3 Formulation and selection of appropriate starting mate-
D 926 Test Method for Rubber Property—Plasticity and
rialsiscoveredinthecompaniondocument,F 2038PartI.This
2
Recovery (Parallel Plate Method)
monograph addresses only the curing, post-curing, and pro-
D 955 Test Method of Measuring Shrinkage from Mold
cessing of elastomers, gels and foams as well as how the
3
Dimensions of Molded Plastics
resulting product is evaluated.
D 1349 Practice for Rubber—Standard Temperatures for
1.4 Silicone biocompatibility issues can be addressed at
2
Testing
several levels, but ultimately the device manufacturer must
2
D 1566 Terminology Relating to Rubber
assess biological suitability relative to intended use. Biocom-
D 2240 Test Method for Rubber Property—Durometer
patibilitytestingmaybedoneoncuredelastomerspriortofinal
2
Hardness
fabrication,butthemostrelevantdataarethoseobtainedonthe
4
F 619 Practice for Extraction of Medical Plastics
finished device. Data on selected lots of material are only
F 719 Practice for Testing Biomaterials in Rabbits for
representative when compounding, and fabrication are per-
4
Primary Skin Irritation
formed under accepted quality systems such as ISO 9001 and
F 720 Practice for Testing Guinea Pigs for Contact
current Good Manufacturing Practice Regulations. Extract-
4
Allergens—Guinea Pig Maximization Test
ables analyses may also be of interest for investigation of
F 748 Practice for Selecting Generic Biological Test Meth-
biocompatibility, and the procedures for obtaining such data
4
ods for Materials and Devices
depend on the goal of the study (see F 619, the HIMA
F 813 PracticeforDirectContactCellCultureEvaluationof
Memorandum 7/14/93, and USP23, for examples of extraction
4
Materials for Medical Devices
methods).
F 981 Practice for Assessment of Compatibility of Bioma-
2. Referenced Documents
terials for Surgical Implantation With Respect to Effect of
4
Materials on Muscle and Bone
2.1 ASTM Standards:
F 1905 Practice for Selecting Tests for Determining the
D 395 Test Methods for Rubber Property—Compression
4
2
Propensity of Materials to Cause Immunotoxicity
Set
2
F 1906 Practice for Evaluation of Immunological Re-
D 412 Test Methods for Rubber Properties in Tension
sponses in Biocompatibility Testing Using ELISA Tests,
4
Lymphocyte Proliferation, and Cell Migration
1
This specification is under the jurisdiction of ASTM Committee F04 on F 1984 Practice for Testing Whole Complement Activation
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F4.11 on Polymeric Materials.
3
Current edition approved July 10, 2000. Published October 2000. Annual Book of ASTM Standards, Vol 08.01.
2 4
Annual Book of ASTM Standards, Vol 09.01. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2042
4
in Scrum by Solid Materials PCB Test Methods such as those used for MRI project No.
11
F 2038 Guide for Silicone Elastomers, Gels and Foams 4473, 1/24/97,
Used in Medical applications Part I: Formulations and Biological Performance of Materials: J. Black, Marcel De-
4
Uncured Materials kker, NY 1992
2.2 Other Biocompatibility Standards:
3. Terminology
United States Pharmacopeia, current edition (appropriate
5
monographs may include: <87>, <88>, <151>, <381>)
3.1
...

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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.  
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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
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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.
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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.  
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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.  
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ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
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.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
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.  
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.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off