ASTM F451-21 Standard Specification for Acrylic Bone Cement

The “ASTM F451-21 Standard specification for acrylic bone cement” standard developed by the American Society for Testing and Materials (ASTM) describes the requirements for self-curing resins used mainly for fixation of internal orthopedic prostheses.

The mixture can be used in predough or dough stages in accordance with the manufacturer's recommendations. It is supplied in a form suitable for mixing pre-measured powder and liquid units. The mixture is then set in place. Various copolymers and comonomers may be included, but the composition of the hardened cement must contain poly(methacrylic acid esters) as its main component.

This standard covers compositional, physical performance and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as conventionally formulated and used has been reported in the literature.

For the purposes of this standard, the following terms and definitions apply:

• Doughing time or dough time refers to the time after the start of mixing at which the mixture stops sticking to a standard probe.
• Exothermic or maximum temperature refers to the maximum temperature resulting from the self-curing of the mixture in a standard mold.
• Extrusion refers to the rate at which material flows through a standard orifice under load.
• Intrusion refers to the flow distance of the mixture into a standard mold under load.
• Curing time refers to the time at which the temperature of the curing mass after the start of mixing is equal to the average of the maximum and ambient temperatures.
• Unit refers to one packet or bottle of pre-measured powder component and one packet or bottle of pre-measured liquid component.

The physical requirements in this standard include:

• The liquid component includes monomer, inhibitors, accelerators and, if applicable, colorants. In appearance, the liquid should be free from foreign particulate matter or obvious visual contaminants in its container. In terms of stability, after heating at 60 degrees plus/minus 2 degrees for 48 hours, the viscosity of the liquid should not increase by more than 10 percent of its original value. The liquid poured from its container must pass the tests described in the “Sterility tests - Liquids and ointments” section of the standard.
• The powder component includes polymer particles, initiators, radiopaque material and other additives such as antibiotics and colorants if present. In appearance, the powder should be pourable and free from foreign matter such as dirt or lint. The powder, as poured from its packaging, should pass the tests described in the “Sterility tests - Solids” section of the standard.
• The powder-liquid mixture must comply with the specifications shown in the table given in the standard.
• After hardening, the cured cement must conform to the properties shown in the table given in the standard.

Weight and volume measurements shall be made on the respective powder and liquid components of the five units. These units may then be used in any of the nonsterile tests of this specification. The weights or volumes of the powder and liquid components, or both, shall not deviate by more than 5 percent from those stated on the packaging of each of the five units.

Powder and liquid units are supplied to provide sufficient material for all tests described in this standard. The units are obtained through normal retail distribution channels. This should be between seven and ten units unless retesting is required.

Not all tests described in this standard need to be performed under sterile conditions.

Unless otherwise specified, all equipment, mixing surfaces and materials are maintained at 2 degrees plus/minus 23 degree for at least 1 hours prior to testing and all tests are conducted at 23 degrees plus/minus 1 degree and 50 percent plus/minus 10 percent relative humidity.

Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the "ASTM F451-21 Standard Specification for Acrylic Bone Cement" standard with its trained and expert staff and advanced technological equipment.