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ASTM F 1441 : 2003 : R2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Soft-Tissue Expander Devices
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

04-01-2009

CONTAINED IN VOL. 13.01, 2015 Describes 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.

1.1 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.

Committee
F 04
DocumentType
Standard
Pages
5
ProductNote
Reconfirmed 2009
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ASTM D 1349 : 2014 : REDLINE Standard Practice for Rubber—Standard Conditions for Testing
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization

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