ASTM F 1581 : 2008 : R2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Specification for Composition of Anorganic Bone for Surgical Implants
Hardcopy , PDF
03-09-2020
English
01-10-2016
CONTAINED IN VOL. 13.01, 2016 Describes material requirements for anorganic xenogeneic or allogeneic bone (apatite) used for surgical implants.
Committee |
F 04
|
DocumentType |
Standard
|
Pages |
4
|
ProductNote |
Reconfirmed 2016
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
1.1This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1).
1.2The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7).
1.3This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.
1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5Warning—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 Safety Data Sheet (DS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.6This standard does not purport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, 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. (See Appendix X2).
ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
ASTM F 1185 : 2003 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
ASTM D 2972 : 2015 | Standard Test Methods for Arsenic in Water |
ASTM D 3919 : 2015 | Standard Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry (Withdrawn 2024) |
ASTM E 1184 : 2010 : R2016 | Standard Practice for Determination of Elements by Graphite Furnace Atomic Absorption Spectrometry |
ASTM D 1688 : 2002 | Standard Test Methods for Copper in Water |
ASTM D 1688 : 2012 | Standard Test Methods for Copper in Water |
ASTM D 3557 : 2002 : R2007 : EDT 1 | Standard Test Methods for Cadmium in Water |
ASTM D 3919 : 2004 | Standard Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry |
ASTM D 3559 : 1996 | Standard Test Methods for Lead in Water |
ASTM D 3559 : 2008 | Standard Test Methods for Lead in Water |
ASTM D 2972 : 2003 | Standard Test Methods for Arsenic in Water |
ASTM E 1184 : 2002 | Standard Practice for Electrothermal (Graphite Furnace) Atomic Absorption Analysis |
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 3557 : 2017 | Standard Test Methods for Cadmium in Water |
ASTM D 4129 : 1998 | Standard Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection |
ASTM D 1688 : 1990 | Standard Test Methods for Copper in Water |
ASTM D 513 : 2016 : REDLINE | Standard Test Methods for Total and Dissolved Carbon Dioxide in Water |
ASTM E 1184 : 2010 | Standard Practice for Determination of Elements by Graphite Furnace Atomic Absorption Spectrometry |
ASTM D 4129 : 2005 : R2012 | Standard Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection |
ASTM D 3591 : 2017 : REDLINE | Standard Test Method for Determining Logarithmic Viscosity Number of Poly(Vinyl Chloride) (PVC) in Formulated Compounds |
ASTM D 1688 : 1995 | Standard Test Methods for Copper in Water |
ASTM D 3919 : 2008 | Standard Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry |
ASTM D 3557 : 1990 | Standard Test Methods for Cadmium in Water |
ASTM D 2972 : 1997 | Standard Test Methods for Arsenic in Water |
ASTM D 4129 : 2005 : R2013 | Standard Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection |
ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ASTM D 1688 : 2017 | Standard Test Methods for Copper in Water |
ASTM D 3559 : 2003 | Standard Test Methods for Lead in Water |
ASTM D 3557 : 2012 | Standard Test Methods for Cadmium in Water |
ASTM D 3557 : 2002 | Standard Test Methods for Cadmium in Water |
ASTM D 2972 : 2015 : REDLINE | Standard Test Methods for Arsenic in Water |
ASTM D 3919 : 1999 | Standard Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry |
ASTM D 4129 : 2005 : R2020 | Standard Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection |
ASTM D 3557 : 1995 | Standard Test Methods for Cadmium in Water |
ASTM D 4129 : 2005 | Standard Test Method for Total and Organic Carbon in Water by High Temperature Oxidation and by Coulometric Detection |
ASTM D 2972 : 1993 | Standard Test Methods for Arsenic in Water |
ASTM F 1185 : 2003 : R2014 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
ASTM D 1688 : 2017 : REDLINE | Standard Test Methods for Copper in Water |
ASTM F 1185 : 2003 : R2009 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
ASTM D 3559 : 2015 | Standard Test Methods for Lead in Water (Withdrawn 2024) |
ASTM D 3557 : 2017 : REDLINE | Standard Test Methods for Cadmium in Water |
ASTM D 1688 : 2007 | Standard Test Methods for Copper in Water |
ASTM E 1184 : 1998 | Standard Practice for Electrothermal (Graphite Furnace) Atomic Absorption Analysis |
ASTM D 2972 : 2008 | Standard Test Methods for Arsenic in Water |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.