Logo

ASTM F750-20

Current Revision

Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

$61.00

$61.00

$109.80

$73.00

$73.00

$131.40



Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


Stay effortlessly up-to-date with the latest standard revisions. When new versions are released, they're automatically charged and delivered to you, ensuring seamless compliance.

...

1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.

1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.

1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.

1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This 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.


4.1 This practice is intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.

4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.

4.3 The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.

SDO ASTM: ASTM International
Document Number F750
Publication Date June 1, 2020
Language en - English
Page Count 4
Revision Level 20
Supercedes
Committee F04.16
Publish Date Document Id Type View
June 1, 2020 F0750-20 Revision
Feb. 1, 2007 F0750-87R07E01 Revision
Oct. 1, 2012 F0750-87R12 Reaffirmation
Feb. 1, 2007 F0750-87R07 Reaffirmation
Sept. 25, 1987 F0750-87R02E01 Reaffirmation
Sept. 25, 1987 F0750-87R02 Reaffirmation
Sept. 25, 1987 F0750-87R96 Reaffirmation