ASTM F1441-03(2009)

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
This specification contains requirements based on state-of-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.
This specification is not intended to limit the science and technology that may be considered and applied to ensure performance characteristics of subject device in intended applications. When new information becomes available or changes in state-of-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 6 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Mar-2009
• 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

Relations

• Replaces: ASTM F1441-03 - Standard Specification for Soft-Tissue Expander Devices
• Effective Date: 01-Apr-2009

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:F1441 −03(Reapproved 2009)
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 F1251 Terminology Relating to Polymeric Biomaterials in
3
Medical and Surgical Devices (Withdrawn 2012)
1.1 This specification covers the requirements for single use
F2038 GuideforSiliconeElastomers,Gels,andFoamsUsed
saline inflatable, smooth and textured tissue expansion devices
in Medical Applications Part I—Formulations and Un-
to be used intraoperatively or implanted for typically less than
cured Materials
6 months and then removed.
F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
1.2 Limitations:
in Medical Applications Part II—Crosslinking and Fabri-
1.2.1 This specification applies only to soft-tissue expander
cation
devicesfabricatedwithelastomershells.Itdoesnotnecessarily
F2051 Specification for Implantable Saline Filled Breast
cover any custom fabricated soft tissue expander device
Prosthesis
manufactured to any other specification.
2.2 Other Documents:
1.2.2 This specification applies, in part, to combination
4
Federal Register, Title 21, Part 820
“expander/mammary” devices as classified in Section 4.
5
USP (United States Pharmacopoeia)
1.3 The values stated in SI units are to be regarded as
Association for the Advance of Medical Instrumentation:
standard, values in parentheses are for information only.
ANSI/AAMI/ISO 10993-1 Biological Testing of Medical
and Dental Materials and Devices—Part 1: Guidance on
1.4 The following statement pertains only to the test meth-
6
ods and requirements portion, Section 9, of this specification. Selection of Tests
6
ANSI/AAMI/ST50 Dry Heat (Heated Air) Sterilizers
This standard does not purport to address all of the safety
concerns, if any, associated with its use. It is the responsibility ANSI/AAMI/ISO 11135 Medical Devices—Validation and
6
Routine Control of Ethylene Oxide Sterilization
of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory ANSI/AAMI/ISO 11137 Sterilization of Health Care
Products—Requirements for Validation and Routine and
limitations prior to use.
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-
7
and Depyrogenation
canized Rubber and Thermoplastic Elastomers
D1349 Practice for Rubber—Standard Temperatures for
3. Terminology
Testing
F703 Specification for Implantable Breast Prostheses
3.1 Definitions:
F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
3
The last approved version of this historical standard is referenced on
www.astm.org.
1 4
This specification is under the jurisdiction of ASTM Committee F04 on AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Medical and Surgical Materials and Devices and is the direct responsibility of 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
Subcommittee F04.32 on Plastic and Reconstructive Surgery. www.access.gpo.gov.
5
Current edition approved April 1, 2009. Published April 2009. Originally United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA
approved in 1992. Last previous edition approved in 2003 as F1441 – 03. DOI: 1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,
10.1520/F1441-03R09. Rockville, NC 00852.
2 6
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
7
Standards volume information, refer to the standard’s Document Summary page on Available from the Parenteral Drug Association, 3 Bethesda Medical Center,
the ASTM website. Suite 1500, Bethesda, MD 20814.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1441−03 (2009)
3.1.1 injection port—the port through which an injection to 4.3.1 Gel/Saline—Expansion indications for devices of
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F1441–92 (Reapproved 1998) Designation: F 1441 – 03 (Reapproved 2009)
Standard Specification for
1
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 (´) indicates an editorial change since the last revision or reapproval.
1. 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 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. :
1.2.1 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 79, of this specification. This
standard does not purport to address all of the safety problems,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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 412 Test Methods for Rubber Properties in Tension
Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
2
D 624 Test Method for Rubber Property—Tear Resistance
Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
2
D 1349 Practice for Rubber—Standard Temperatures for Testing
F604Classification for Silicon Elastomers Used in Medical Applications
Practice for RubberStandard Temperatures for Testing
F 703 Specification for Implantable Breast Prostheses
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3
F 1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
2.2 Federal Register:
Title 21,Part 820 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F 2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part IFormulations and Uncured
Materials
F 2042 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part IICrosslinking and Fabrication
F 2051 Specification for Implantable Saline Filled Breast Prosthesis
2.2 Other Documents:
3
Federal Register, Title 21, Part 820
4
USP (United States Pharmacopoeia)
Association for the Advance of Medical Instrumentation:
1
This specification is under the jurisdiction ofASTM Committee F-4F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.06F04.32 on Plastic and Reconstructive Surgery.
Current edition approved Dec. 15, 1992. Published February 1993.
Current edition approved April 1, 2009. Published April 2009. Originally approved in 1992. Last previous edition approved in 2003 as F 1441 – 03.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
, Vol 09.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 13.01.
3
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
4
Available from U.S. Government Printing Office, Superintendent of Documents, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 1441 – 03 (2009)
ANSI/AAMI/ISO 10993-1 Biological Testing of Medical and Dental Materials and Devices—Part 1: Guidance on Selection of
5
Tests
5
ANSI/AAMI/ST50 Dry Heat (Heated Air) Sterilizers
5
ANSI/AAMI/ISO 11135 Medical Devices—Validation and Ro
...