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ASTM
ASTM F 1027 : 1986 : R2017

ASTM F 1027 : 1986 : R2017

Current

Current

The latest, up-to-date edition.

Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-01-2017

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2017 Describes a procedure to assess the cytotoxic potential of materials for use in the construction of medical materials and devices using human excised donor (HED) tissues and their derived primary cells taken from the orofacial region.

1.1This practice describes a procedure to assess the cytotoxic potential of materials for use in the construction of medical materials and devices using human excised donor (HED) tissues and their derived primary cells taken from the orofacial region.

1.2This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity methods may be compared.

1.3This practice is one of a series of reference methods for assessment of cytotoxic potential, employing different techniques.

1.4Assessment of cytotoxicity is one of several procedures employed in determining the biological response to a material, as recommended in Practice F748.

1.5This 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.

1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee
F 04
DocumentType
Standard Practice
Pages
11
ProductNote
Reconfirmed 2017
PublisherName
American Society for Testing and Materials
Status
Current
SupersededBy
Supersedes

ASTM F 748 : 2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 813 : 2007 : R2012 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
ASTM F 813 : 2020 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

ASTM F 703 : 2018 Standard Specification for Implantable Breast Prostheses
ASTM D 883 : 2022 Standard Terminology Relating to Plastics
ASTM D 883 : 2020 : REV B Standard Terminology Relating to Plastics
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 703 : 2018 : R2022 Standard Specification for Implantable Breast Prostheses
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)

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