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ASTM F1839-97

(Specification)

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1 Rationale for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.
1.5 This specification provides qualification criteria for vendor or end-user processes and acceptance criteria for individual material lots.
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.
1.7 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: 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.

General Information

Status
Historical
Publication Date
09-Oct-2001
ICS
11.040.01 - Medical equipment in general
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaced By
ASTM F1839-01 - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
Effective Date
10-Oct-2001

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ASTM F1839-97 - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and InstrumentsASTM F1839-97 - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
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ASTM F1839-97 - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
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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: F 1839 – 97
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Specification for
Rigid Polyurethane Foam for Use as a Standard Material for
1
Testing Orthopaedic Devices and Instruments
This standard is issued under the fixed designation F 1839; 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. Scope 2. Referenced Documents
1.1 This specification covers rigid unicellular polyurethane 2.1 ASTM Standards:
foam for use as a standard material for performing mechanical C 273 Test Method for Shear Test in Flatwise Plane of Flat
3
tests utilizing orthopaedic devices or instruments. The specifi- Sandwich Constructions or Sandwich Cores
cation is applicable to sheets or blocks of foam, or foam that is D 1621 Test Method for Compressive Properties of Rigid
4
made by the user using a two-part liquid mixture. Cellular Plastics
1.2 This specification covers polyurethane foam material D 1622 Test Method for Apparent Density of Rigid Cellular
4
that is used in the laboratory for mechanical testing, as Plastics
5
described in 1.1. These materials are not intended for implan- E 4 Practices for Load Verification of Testing Machines
tation into the human body. F 117 Test Method for Driving Torque of Medical Bone
6
1.3 The foam described herein possesses mechanical prop- Screws
erties which are on the order of those reported for human F 1691 Test Method for Determining the Axial Pullout of
6
cancellous bone. See Appendix X1 Rationale for further Medical Bone Screws
information regarding the appropriateness of using the speci- 2.2 ISO Standards:
fied foam as a model for human cancellous bone. 5835-1 Implants for Surgery - Metal Bone Screws with
1.4 This specification covers compositional requirements, Hexagonal Driver Connection, Spherical Under Surface of
7
physical requirements, mechanical requirements, and test Head, Asymmetrical Thread - Dimensions
methods for rigid polyurethane foam in the solid final form.
3. Terminology
1.5 This specification provides qualification criteria for
vendor or end-user processes and acceptance criteria for 3.1 Definitions:
3.1.1 final form—the condition of the foam product when
individual material lots.
1.6 This specification provides mechanical properties of five used by the end-user to perform tests of orthopaedic devices or
2
instruments. The condition of the foam product of which all
different grades of foam in the solid final form. A foam that
does not meet the specified mechanical properties shall be physical and mechanical tests required by this specification are
performed.
identified as an ungraded foam.
1.7 Unless otherwise indicated, the values stated in SI units 3.1.1.1 solid—the foam is in a uniform solid form, such as
a slab, plate or block.
are to be regarded as standard. The values in parentheses are
given for information only. 3.1.2 foam rise direction—the nominal direction that the
1.8 The following precautionary statement pertains to the foam rises during the polymerization (“foaming”) process,
either at the suppliers production facilities for the solid
test method portion only, Section 8, of this specification: This
standard does not purport to address all of the safety concerns, supplied foam, or at the end-users facilities for foam produced
from the liquid supplied form. The foam rise direction shall be
if any, associated with its use. It is the responsibility of the user
of this standard to establish appropriate safety and health marked on the foam block or indicated in the shipping
documentation for foam that is supplied in the Solid form.
practices and determine the applicability of regulatory limita-
tions prior to use. 3.1.3 grades—The grade designation refers to the nominal
density of the foam, in its Solid Final form, expressed in units
3 3
of kg/m (lbm/ft ). Five grades of foam have been defined in
this specification. Their nominal densities are given below:
1
This test method is under the jurisdiction of ASTM Committee F-04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
3
F04.21 on Osteosynthesis.
Annual Book of ASTM Standards, Vol 15.03.
4
Current edition approved Dec. 10, 1997. Published May 1998.
Annual Book of ASTM Standards, Vol 08.01.
2
5
General Plastics Manufacturing Company, 4910 Burlington Way, Tacoma
Annual Book of ASTM Standards, Vol 03.01.
6
Washington, 98409, producers of Last-a-Foamt polyurethane foam, has been found
Annual Book of ASTM Standards, Vol 13.01.
7
to be a satisfactory supp
...

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This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
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SCOPE
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5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment  
5.3 For devices that come into contact with blood, the simulated test soils are blood-based soils, such as those described under 7.1.1-7.1.2.  
5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.3.  
5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should be similar to those described in 7.2. These can be used alone or in combination with 7.1.  
5.6 A combination of test soils may be used (e.g., blood with mucus) to simulate clinical soiling. For example, flexible endoscopes may come in contact with a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculature for biopsies) during clinical use.  
5.7 Any simulated test soil(s) or formulations can be used for simulated use testing but shall be scientifically justified by the medical device manufacturer.
SCOPE
1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device.  
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1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.  
1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed.  
1.5 Exclusion:  
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SCOPE
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1....

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Standard Guide for Designing Reusable Medical Devices for Cleanability

SIGNIFICANCE AND USE
4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is essential that cleanability be considered during the design phase.  
4.2 The next section highlights features that either have a tendency to retain debris and/or make removing contamination difficult. Individually, the criteria listed in this document may not render a device difficult to clean. Furthermore, it is the manufacturer’s responsibility to consider feasibility and ease of cleaning the device in the clinical environment when designing their device. Although it may not be feasible to remove or modify all of the problematic design features from a device, device manufacturers should be aware of challenging designs for cleaning and take appropriate action for minimizing the impact of these features on cleaning. For example, disassembly may be necessary to thoroughly clean a device, or it may be determined that a device cannot be adequately cleaned, in which case that device would be designated single-use only. In addition, manufacturers should consider the compatibility of their device design with subsequent sterilization or disinfection.
SCOPE
1.1 This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also prepare for subsequent processing steps (for example, sterilization or disinfection).  
1.2 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.  
1.3 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.

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    7 pages
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ASTM
ASTM F2901-19(Guide)
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

SIGNIFICANCE AND USE
4.1 The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748. This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue.  
4.2 The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications.  
4.3 Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.
SCOPE
1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF).
Note 1: The results of these in vitro and in vivo tests may not correspond to actual human response.  
1.2 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.  
1.3 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
    5 pages
    English language
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  • Guide
    5 pages
    English language
    sale 15% off