 |
| Purchase Information |
| Use this form to request purchase information on ASTM online subscriptions. |
|
|
Document ASTM F 2212 is offered by IHS as part of an online subscription. This subscription contains many documents on the same topic.
You may also purchase this document alone from the IHS Standards Store.
ASTM F 2212 Document Information:
Title
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ASTM International
Publication Date:
Feb 1, 2008
Scope:
This guide for characterizing collagen-containing biomaterials
is intended to provide characteristics, properties, and test
methods for use by producers, manufacturers, and researchers to
more clearly identify the specific collagen materials used. With
greater than 20 types of collagen and the different properties of
each, a single document would be cumbersome. This guide will focus
on the characterization of Type I collagen, which is the most
abundant collagen in mammals, especially in skin and bone. Collagen
isolated from these sources may contain other types of collagen,
for example, Type III and Type V. This guide does not provide
specific parameters for any collagen product or mix of products or
the acceptability of those products for the intended use. The
collagen may be from any source, including, but not limited to
animal or cadaveric sources, human cell culture, or recombinant
sources. The biological, immunological, or toxicological properties
of the collagen may vary depending on the source material. The
properties of the collagen prepared from each of the above sources
must be thoroughly investigated, as the changes in the collagen
properties as a function of source materials is not thoroughly
understood. This guide is intended to focus on purified Type I
collagen as a starting material for surgical implants and
substrates for tissue engineered medical products (TEMPs); some
methods may not be applicable for gelatin nor for tissue implants.
This guide may serve as a template for characterization of other
types of collagen.
The biological response to collagen in soft tissue has been well
documented by a history of clinical use (1,
2)2 and laboratory studies
(3, 4, 5,
6). Biocompatibility and appropriateness of use
for a specific application(s) is the responsibility of the product
manufacturer.
Warning—Mercury has been designated by EPA and
many state agencies as a hazardous material that can cause central
nervous system, kidney, and liver damage. Mercury, or its vapor,
may be hazardous to health and corrosive to materials. Caution
should be taken when handling mercury and mercury-containing
products. See the applicable product Material Safety Data Sheet
(MSDS) for details and EPA's website
(http://www.epa.gov/mercury/faq.htm) for additional information.
Users should be aware that selling mercury or mercurycontaining
products, or both, in your state may be prohibited by state
law.
The following precautionary caveat pertains only to the test
method portion, Section 5, of this guide. 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.
2 The boldface numbers in parentheses refer to the
list of references at the end of this standard.
Keywords:
- biomaterials
- characterization
- collagen
- natural materials
- TEMPs
About IHS
IHS (NYSE: IHS) is a leading global provider of critical technical information, decision-support tools and related services in a number of industries including aerospace and defense, automotive, construction, electronics, and energy. IHS serves customers ranging from large governments and multinational corporations to smaller companies and technical professionals in more than 100 countries. IHS been in business for more than 45 years and employ more than 2,300 people around the world.
