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ASTM F1441-03(2022)

(Specification)

Standard Specification for Soft-Tissue Expander Devices

Standard Specification for Soft-Tissue Expander Devices

ABSTRACT
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.
SIGNIFICANCE AND USE
5.1 This specification contains requirements based on state-of-the-art science and technology as applicable to various considerations that have been identified as important to ensure reasonable safety and efficacy as it relates to the biocompatibility and the mechanical integrity of the device components in soft-tissue expander devices.  
5.1.1 This specification is not intended to limit the science and technology that may be considered and applied to ensure performance characteristics of subject devices in intended applications. When new information becomes available or changes in state-of-the-art science and technology occur and relevance to subject devices has been established by valid science, it is intended that this specification will be revised in accordance with ASTM guidelines.
SCOPE
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.  
1.2 Limitations:  
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.  
1.2.2 This specification applies in part to combination “expander/mammary” devices as classified in Section 4.  
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 and requirements portion, Section 9, 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, 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.

General Information

Status
Published
Publication Date
30-Sep-2022
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

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ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander DevicesASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
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ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
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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.
Designation: F1441 −03 (Reapproved 2022)
Standard Specification for
1
Soft-Tissue Expander Devices
This standard is issued under the fixed designation F1441; 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 canized Rubber and Thermoplastic Elastomers
D1349 Practice for Rubber—Standard Conditions for Test-
1.1 Thisspecificationcoverstherequirementsforsingle-use
ing
saline inflatable, smooth and textured tissue expansion devices
F703 Specification for Implantable Breast Prostheses
to be used intraoperatively or implanted for typically less than
F748 PracticeforSelectingGenericBiologicalTestMethods
six months and then removed.
for Materials and Devices
1.2 Limitations:
F1251 Terminology Relating to Polymeric Biomaterials in
3
1.2.1 This specification applies only to soft-tissue expander
Medical and Surgical Devices (Withdrawn 2012)
devicesfabricatedwithelastomershells.Itdoesnotnecessarily
F2038 GuideforSiliconeElastomers,Gels,andFoamsUsed
cover any custom fabricated soft tissue expander device
in Medical Applications Part I—Formulations and Un-
manufactured to any other specification.
cured Materials
1.2.2 This specification applies in part to combination
F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
“expander/mammary” devices as classified in Section 4.
in Medical Applications Part II—Crosslinking and Fabri-
cation
1.3 The values stated in SI units are to be regarded as
standard; values in parentheses are for information only. F2051 Specification for Implantable Saline Filled Breast
Prosthesis
1.4 The following statement pertains only to the test meth-
2.2 Other Documents:
ods and requirements portion, Section 9, of this specification:
4
Federal Register Title 21, Part 820
This standard does not purport to address all of the safety
5
USP (United States Pharmacopoeia)
concerns, if any, associated with its use. It is the responsibility
Association for the Advance of Medical Instrumentation:
of the user of this standard to establish appropriate safety,
ANSI/AAMI/ISO 10993-1 Biological Testing of Medical
health, and environmental practices and determine the appli-
and Dental Materials and Devices—Part 1: Guidance on
cability of regulatory limitations prior to use.
6
Selection of Tests
1.5 This international standard was developed in accor-
6
dance with internationally recognized principles on standard- ANSI/AAMI/ST50 Dry Heat (Heated Air) Sterilizers
ANSI/AAMI/ISO 11135 Medical Devices—Validation and
ization established in the Decision on Principles for the
6
Development of International Standards, Guides and Recom- Routine Control of Ethylene Oxide Sterilization
ANSI/AAMI/ISO 11137 Sterilization of Health Care
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. Products—Requirements for Validation and Routine and
6
Routine Control—Radiation Sterilization
2. Referenced Documents
ANSI/AAMI/ISO 11134 Sterilization of Health Care
2
Products—Requirements for Validation and Routine
2.1 ASTM Standards:
6
Control—Industrial Moist Heat Sterilization
D412 Test Methods forVulcanized Rubber andThermoplas-
Parenteral Drug Association 1981 Technical Report No. 3,
tic Elastomers—Tension
Validation of Dry Heat Processes Used for Sterilization
D624 Test Method for Tear Strength of Conventional Vul-
1 3
This specification is under the jurisdiction of ASTM Committee F04 on The last approved version of this historical standard is referenced on
Medical and Surgical Materials and Devices and is the direct responsibility of www.astm.org.
4
Subcommittee F04.32 on Plastic and Reconstructive Surgery. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Current edition approved Oct. 1, 2022. Published October 2022. Originally 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
approved in 1992. Last previous edition approved in 2014 as F1441 – 03 (2014). www.access.gpo.gov.
5
DOI: 10.1520/F1441-03R22. United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Rockville, NC 00852.
6
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, N
...

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SCOPE
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SCOPE
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SCOPE
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SCOPE
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ASTM
ASTM D8042-18(2023)(Test Method)
Test Method for Shrinkage Temperature of Wet Blue and Wet White

SIGNIFICANCE AND USE
5.1 This test method is designed to determine the temperature at which the Wet Blue or Wet White specimen experiences shrinkage. In this test method, shrinkage occurs as a result of hydrothermal denaturation of the collagen protein molecules which make up the fiber structure of the Wet Blue or Wet White. The shrinkage temperature of Wet Blue or Wet White is influenced by many different factors, most of which appear to affect the number and nature of crosslinking interactions between adjacent polypeptide chains of the collagen protein molecules. The value of the shrinkage temperature of Wet Blue or Wet White is commonly used as an indicator of the type of tannage or the degree of tannage, or both, of that particular Wet Blue or Wet White (especially for the more hydrothermally stable tannages such as chrome tannage).
SCOPE
1.1 This test method covers the determination of the shrinkage temperature of all types of Wet Blue and Wet White. The heating medium is water when the shrinkage temperature is at or below 98 °C. The heating medium is a glycerine-water solution when the shrinkage temperature is above 98 °C.  
1.2 The values stated in SI units are to be regarded as the standard. The values in parentheses are for information only.  
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.  
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.

  • Standard
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