Logo

ASTM F2311-06

Historical Revision

Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)

$83.00

$83.00

$149.40


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


...

1.1 This guide defines terminology and provides a system of classification for products that can be substituted for human or animal skin grafts (or grafts of the dermal or epidermal component tissues of skin) in medical and surgical therapies. This guide is intended to include (or be expandable to) possible future tissue engineered skin technology that could provide novel or superior therapeutic properties to those of natural skin grafts.

1.2 As much as possible, terminology is based on medical dictionary definitions.

1.3 Substitutes for skin grafts are classified by clinical utility only; the classification is independent of the technology used to make a skin substitute, its components, or whether the sources of components include human or animal tissue or other biological or non-biological materials.

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 and health practices and determine the applicability of regulatory requirements prior to use.


This guide is intended to provide the foundation of standards for clinical assessment, clinical performance, and preclinical assessment of substitutes for skin grafts.

This guide is intended to aid accurate claims and labeling for the clinical utilities of substitutes for skin grafts in regulatory reviews.

In this guide, replacement and substitute have different meanings, although they can be used synonymously in ordinary English. Replacement is used only as an adjective in the context of skin replacement surgery, which is defined in . Substitute is used only as a noun in the context of skin substitute, which is defined in 2.1.7.11.

SDO ASTM: ASTM International
Document Number F2311
Publication Date May 1, 2006
Language en - English
Page Count 5
Revision Level 06
Supercedes
Committee F04.41
Publish Date Document Id Type View
Oct. 1, 2008 F2311-08 Revision
May 1, 2006 F2311-06 Revision
Sept. 10, 2003 F2311-03 Revision