ASTM F1441-92(1998)

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: 09-Oct-1998
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.32 - Plastic and Reconstructive Surgery

Relations

• Replaced By: ASTM F1441-92(2002) - Standard Specification for Soft-Tissue Expander Devices
• Effective Date: 15-Dec-1992

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1441 – 92 (Reapproved 1998)
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
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 3.1.1.1 remote port—a port that is remote from the shell and
attached to the shell by means of tubing.
1.1 This specification covers the requirements for inflatable
3.1.1.2 self-contained (integrated) port—a port that is inte-
tissue expansion devices to be used intraoperatively or im-
gral to the device shell.
planted for typically less than 6 months and then removed.
3.1.2 injection surface—the area of the injection port rec-
1.2 Limitations—This specification applies only to soft-
ommended by the manufacturer for needle insertion to inflate
tissue expander devices fabricated with elastomer shells. It
or deflate the device.
does not necessarily cover any custom fabricated soft tissue
3.1.3 needle stop—the injection port component used to
expander device manufactured to any other specification.
limit hypodermic needle penetration through the port.
1.3 The values stated in SI units are to be regarded as
3.1.4 reinforced silicone elastomer—a composite of silicone
standard, values in parentheses are for information only.
elastomer and an embedded textile made from polyethylene
1.4 The following statement pertains only to the test meth-
terephthalate (Dacront) fibres.
ods portion, Section 7, of this specification. This standard does
3.1.5 shell—an outer sac of the device which is comprised
not purport to address all of the safety problems, if any,
of silicone elastomer (or other appropriate material).
associated with its use. It is the responsibility of the user of this
3.1.6 tubing length adapter—the tissue expander compo-
standard to establish appropriate safety and health practices
nent used to connect more than one piece of remote port
and determine the applicability of regulatory limitations prior
tubing.
to use.
3.1.7 tubing/shell junction—the junction of the remote port
2. Referenced Documents
tubing to the shell of the tissue expander.
3.2 For other terms used in this specification see Terminol-
2.1 ASTM Standards:
ogy F 1251.
D 412 Test Methods for Rubber Properties in Tension
D 624 Test Method for Rubber Property—Tear Resistance
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 Classification 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
3 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:
4 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
3.1.1 injection port—the port through which an injection to
6.1 Biocompatibility:
inflate or deflate the variable volume device is made.
6.1.1 Biological testing to ensure safety of soft tissue
expander devices shall be selected and conducted in accor-
dance with Practice F 748.
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
6.1.2 In addition to biological testing as recommended by
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.06 on Plastic and Reconstructive Surgery. Practice F 748, other biological testing may be appropriate.
Current edition approved Dec. 15, 1992. Published February 1993.
6.2 Physical Properties:
Annual Book of ASTM Standards, Vol 09.01.
6.2.1 Tensile Set—Maximum set shall be less than 10 %
Annual Book of ASTM Standards, Vol 13.01.
when tested in accordance with 7.2.1.
Available from U.S. Government Printing Office, Superintendent of Docu-
ments, Washington, DC 20402.
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1441
FIG. 1 Testing Fused or Adhered Joints
6.2.2 Breaking Force—Ultimate breaking force in tension stressed to 6.672-N (1.5-lb) tension.
shall be no less than 11.12 N (2.5 lb) when tested in accordance
7.3.2 Tubing Less Than or Equal to 2.3 mm (0.090 in.) in
with 7.2.3.
Outer Diameter—The tubing/shell junction shall not fail when
6.2.3 Tear Resistance—Tear resistance shall be 3.5584 N
stressed to 2.224-N (0.5-lb) tension.
(0.8 lb) minimum when tested in accordance with 7.2.3.
7.4 Injection Port Competence—There shall be no Type I
tissue expander port leakage observed when an injection port is
7. Test Methods
tested under the following conditions. Apply 120-mm Hg
7.1 Tissue expander or component designs, or both, shall
intraluminal pressure to the port using water or test media with
demonstrate an acceptable response to the following tests.
demonstrated equivalence. Using the prescribed gauge hypo-
Unless otherwise specified, the standard temperature for testing
dermic needle, puncture the port 5 consecutive times within 1
shall be 23 6 2°C (73.4 6 3.6°F). Condition the test specimens
for at least 3 h when the test temperature is 23 6 2°C. If the mm at a site near the center of the port. The port is considered
material is affected by moisture, maintain the relative humidity
leaking and fails the test if beads of fluid on the port surface are
at 50 6 5 % and condition the specimen for at least 24 h prior
not static after 30 s.
to testing. When testing at any other temperature is required,
7.4.1 21 Gage Port—An injection port may be labelled a
use one of the temperatures specified in Practice D 1349.
21G port only if it passes the injection port competence test
7.2 Shell—Cut the test specimens from units made by
when tested with a 21G hypodermic needle.
standard production processes including sterilization. Clean
7.4.2 23 Gage Port—An injection port may be labelled a
with appropriate (polar, for example, 2-propanol, or nonpolar,
23G port only if it passes the injection port competence test
for example, 1,1,1-trichloroethane) solvent if necessary.
when tested with a 23G hypodermic needle.
7.2.1 Tensile Set—At 300 % elongation, stress the test
7.4.3 25 Gage Port—An injection port may be labelled a
specimens for 3 min. Remove the load, then allow 3 min for
relaxation. Test
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