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ASTM F1441-92(2002)

(Specification)

Standard Specification for Soft-Tissue Expander Devices

Standard Specification for Soft-Tissue Expander Devices

SCOPE
1.1 This specification covers the requirements for inflatable tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed.
1.2 Limitations—This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification.
1.3 The values stated in SI units are to be regarded as standard, values in parentheses are for information only.
1.4 The following statement pertains only to the test methods portion, Section 7, of this specification.This standard does not purport to address all of the safety problems, 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
14-Dec-1992
ICS
85.100 - Equipment for the paper industry
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.32 - Plastic and Reconstructive Surgery
Current Stage
Ref Project

Relations

Replaces
ASTM F1441-92(1998) - Standard Specification for Soft-Tissue Expander Devices
Effective Date
15-Dec-1992
Replaced By
ASTM F1441-03 - Standard Specification for Soft-Tissue Expander Devices
Effective Date
10-Apr-2003

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ASTM F1441-92(2002) - Standard Specification for Soft-Tissue Expander DevicesASTM F1441-92(2002) - Standard Specification for Soft-Tissue Expander Devices
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ASTM F1441-92(2002) - Standard Specification for Soft-Tissue Expander Devices
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NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1441 – 92 (Reapproved 2002)
Standard Specification for
Soft-Tissue Expander Devices
This standard is issued under the fixed designation F 1441; 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 3.1.1 injection port—the port through which an injection to
inflate or deflate the variable volume device is made.
1.1 This specification covers the requirements for inflatable
3.1.1.1 remote port—a port that is remote from the shell and
tissue expansion devices to be used intraoperatively or im-
attached to the shell by means of tubing.
planted for typically less than 6 months and then removed.
3.1.1.2 self-contained (integrated) port—a port that is inte-
1.2 Limitations—This specification applies only to soft-
gral to the device shell.
tissue expander devices fabricated with elastomer shells. It
3.1.2 injection surface—the area of the injection port rec-
does not necessarily cover any custom fabricated soft tissue
ommended by the manufacturer for needle insertion to inflate
expander device manufactured to any other specification.
or deflate the device.
1.3 The values stated in SI units are to be regarded as
3.1.3 needle stop—the injection port component used to
standard, values in parentheses are for information only.
limit hypodermic needle penetration through the port.
1.4 The following statement pertains only to the test meth-
3.1.4 reinforced silicone elastomer—a composite of silicone
ods portion, Section 7, of this specification. This standard does
elastomer and an embedded textile made from polyethylene
not purport to address all of the safety problems, if any,
terephthalate (Dacront) fibres.
associated with its use. It is the responsibility of the user of this
3.1.5 shell—an outer sac of the device which is comprised
standard to establish appropriate safety and health practices
of silicone elastomer (or other appropriate material).
and determine the applicability of regulatory limitations prior
3.1.6 tubing length adapter—the tissue expander compo-
to use.
nent used to connect more than one piece of remote port
2. Referenced Documents
tubing.
3.1.7 tubing/shell junction—the junction of the remote port
2.1 ASTM Standards:
tubing to the shell of the tissue expander.
D 412 Test Methods for Vulcanized Rubber and Thermo-
3.2 For other terms used in this specification see Terminol-
plastic Elastomers-Tension
ogy F 1251.
D 624 Test Method for Tear Strength of Conventional
Vulcanized Rubber and Thermoplastic Elastomers
4. Classification
D 1349 Practice for Rubber—Standard Temperatures for
2 4.1 Type I: Chronic Tissue Expansion Device—A soft tissue
Testing
expander device intended to be inflated postoperatively.
F 604 Specification for Silicon Elastomers Used in Medical
3 4.2 Type II: Immediate Tissue Expansion Device—A soft
Applications
tissue expander device only intended for intraoperative use.
F 748 Practice for Selecting Generic Biological Test Meth-
ods for Materials and Devices
5. Significance and Use
F 1251 Terminology Relating to Polymeric Biomaterials in
5.1 The devices described in this specification are intended
Medical and Surgical Devices
for use in soft tissue expansion. This specification identifies
2.2 Federal Register:
those factors felt to be important to ensure safety as it relates
Title 21, Part 820
to the device biocompatibility and the mechanical integrity of
3. Terminology the device components.
3.1 Definitions:
6. Requirements
6.1 Biocompatibility:
This specification is under the jurisdiction of ASTM Committee F04 on
6.1.1 Biological testing to ensure safety of soft tissue
Medical and Surgical Materials and Devices and is the direct responsibility of
expander devices shall be selected and conducted in accor-
Subcommittee F04.32 on Plastic and Reconstructive Surgery.
Current edition approved Dec. 15, 1992. Published February 1993.
dance with Practice F 748.
Annual Book of ASTM Standards, Vol 09.01.
6.1.2 In addition to biological testing as recommended by
Annual Book of ASTM Standards, Vol 13.01.
4 Practice F 748, other biological testing may be appropriate.
Available from U.S. Government Printing Office, Superintendent of Docu-
6.2 Physical Properties:
ments, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1441 – 92 (2002)
6.2.1 Tensile Set—Maximum set shall be less than 10 % when tested with a 25G hypodermic needle.
when tested in accordance with 7.2.1. 7.5 Overexpansion—There shall be no leakage or device
6.2.2 Breaking Force—Ultimate breaking force in tension rupture when the tissue expander is expanded (using water at
shall be no less than 11.12 N (2.5 lb) when tested in accordance ambient conditions) to 200 % of its maximum recommended
with 7.2.3. inflation volume and kept at that volume for a minimum of 10
6.2.3 Tear Resistance—Tear resistance shall be 3.5584 N min.
(0.8 lb) minimum when tested in accordance with 7.2.3. 7.6 Tubing Length Adapter Strength—Two pieces of remote
port tubing attached by means of the tubing length adapter shall
7. Test Methods
not separate when a 152.4-mm (6-in.) test specimen is stressed
7.1 Tissue expander or component designs, or both, shall
at 10 % elongation. Tubing length adapter shall not be ligated
demonstrate an acceptable response to the following tests.
in this test method.
Unless otherwise specified, the standard temperature for testing
7.7 Needle Stop Penetration—Mount a 38.1-mm (1.5-in.)
shall be 23 6 2°C (73.4 6 3.6°F). Condition the test specimens
21-gage hypodermic needle to a syringe. Insert the needle into
for at least 3 h when the test temperature is 23 6 2°C. If the
the injection port, perpendicular to the needle stop. Apply force
material is affected by moisture, maintain the relative humidity
along the axis of the needle, to push it into the needle stop. The
at 50 6 5 % and condition the specimen for at least 24 h prior
needle must fail without penetrating the needle stop.
to testing. When testing at any other temperature is required,
7.8 Fused or Adhered Joints—Requirements for adhered or
use one of the temperatures specified in Practice D 1349.
fused materials shall be critical to their integrity.
7.2 Shell—Cut the test specimens from units made by
7.8.1 Adhered or fused joints or seams that are critical to the
standard production processes including sterilization. Clean
integrity of the device envelope shall not fail when the shell
with appropriate (polar, for example, 2-propanol, or nonpolar,
adjacent to the joint is stressed to 200 % elongation for 10 s
for example, 1,1,1-trichloroethane) solvent if necessary.
(see Fig. 1).
7.2.1 Tensile Set—At 300 % elongation, stress the test
7.8.2 Adhered or fused joints or seams that are bonded to
specimens for 3 min. Remove the load, then allow 3 min for
the device envelope, but are not critical to the envelope
relaxation. Test the
...

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This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.
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1.1 This specification covers the requirements for single-use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than six months and then removed.  
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1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification.  
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This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.
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SCOPE
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Standard Test Method for Evaluation of Load-Carrying Capacity of Lubricants Used in Hypoid Final-Drive Axles Operated under Low-Speed and High-Torque Conditions

SIGNIFICANCE AND USE
5.1 This test method measures a lubricant's ability to protect hypoid final drive axles from abrasive wear, adhesive wear, plastic deformation, and surface fatigue when subjected to low-speed, high-torque conditions. Lack of protection can lead to premature gear or bearing failure, or both.  
5.2 This test method is used, or referred to, in specifications and classifications of rear-axle gear lubricants such as:  
5.2.1 Specification D7450.  
5.2.2 American Petroleum Institute (API) Publication 1560.  
5.2.3 SAE J308.  
5.2.4 SAE J2360.
SCOPE
1.1 This test method, commonly referred to as the L-37-1 test, describes a test procedure for evaluating the load-carrying capacity, wear performance, and extreme pressure properties of a gear lubricant in a hypoid axle under conditions of low-speed, high-torque operation.3  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.2.1 Exceptions—Where there is no direct SI equivalent such as National Pipe threads/diameters, tubing size, or where there is a sole source supply equipment specification.
1.2.1.1 The drawing in Annex A6 is in inch-pound units.  
1.3 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. Specific warning statements are provided in 7.2 and 10.1.  
1.4 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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ASTM
ASTM D6416/D6416M-16(2024)(Test Method)
Standard Test Method for Two-Dimensional Flexural Properties of Simply Supported Sandwich Composite Plates Subjected to a Distributed Load

SIGNIFICANCE AND USE
5.1 This test method simulates the hydrostatic loading conditions which are often present in actual sandwich structures, such as marine hulls. This test method can be used to compare the two-dimensional flexural stiffness of a sandwich composite made with different combinations of materials or with different fabrication processes. Since it is based on distributed loading rather than concentrated loading, it may also provide more realistic information on the failure mechanisms of sandwich structures loaded in a similar manner. Test data should be useful for design and engineering, material specification, quality assurance, and process development. In addition, data from this test method would be useful in refining predictive mathematical models or computer code for use as structural design tools. Properties that may be obtained from this test method include:  
5.1.1 Panel surface deflection at load,  
5.1.2 Panel face-sheet strain at load,  
5.1.3 Panel bending stiffness,  
5.1.4 Panel shear stiffness,  
5.1.5 Panel strength, and  
5.1.6 Panel failure modes.
SCOPE
1.1 This test method determines the two-dimensional flexural properties of sandwich composite plates subjected to a distributed load. The test fixture uses a relatively large square panel sample which is simply supported all around and has the distributed load provided by a water-filled bladder. This type of loading differs from the procedure of Test Method C393, where concentrated loads induce one-dimensional, simple bending in beam specimens.  
1.2 This test method is applicable to composite structures of the sandwich type which involve a relatively thick layer of core material bonded on both faces with an adhesive to thin-face sheets composed of a denser, higher-modulus material, typically, a polymer matrix reinforced with high-modulus fibers.  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. Within the text the inch-pound units are shown in brackets. The values stated in each system are not exact equivalents; therefore, each system must be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.4 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.  
1.5 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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