ASTM F451-99ae1

Standard Specification for Acrylic Bone Cement (Includes all amendments And changes 8/16/2017).

Automatically translated name:

Standard Specification for Acrylic Bone Cement

STANDARD published on 10.5.1999

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The information about the standard:

Designation standards: ASTM F451-99ae1
Note: WITHDRAWN
Publication date standards: 10.5.1999
SKU: NS-55361
The number of pages: 7
Approximate weight : 21 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F451-99ae1 :

Keywords:

acrylic bone cement, compression strength, doughing time, exothermic temperature, extrusion, intrusion, poly(methacrylic acid esters), setting time, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the predough or dough stage in accordance with the manufacturer's recommendations.

1.2 Units of premeasured powder and liquid are supplied in a form suitable for mixing, which then sets in place.

1.3 While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient.

1.4 This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature (1, 2).

1.5 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.

2. Referenced Documents

F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
No. 15	Specification for Acrylic Resin Teeth Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
D3835-16	Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
D695-23	Standard Test Method for Compressive Properties of Rigid Plastics
D638-22	Standard Test Method for Tensile Properties of Plastics
D1193-06(2018)	Standard Specification for Reagent Water
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials

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