ASTM-F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

ASTM-F813 - 2020 EDITION - CURRENT
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Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
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Scope

1.1 This practice describes a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices.

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

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

1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F 748.

1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is an established cell line, well-characterized and readily available, that has demonstrated reproducible results in several laboratories.

1.6 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.

Keywords

biocompatibility; cell culture; cytotoxicity testing; direct contact cytotoxicity; ICS Number Code 07.100.10 (Medical microbiology)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

07.100.10 (Medical microbiology Laboratory medicine, see 11.100)

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Document Number

ASTM-F0813-20

Revision Level

2020 EDITION

Status

Current

Modification Type

Reapproval with Ed Change

Publication Date

July 6, 2020

Document Type

Practice

Page Count

5 pages

Committee Number

F04.16