AS 2265-1983

1 - AS 2265-1983 SURGICAL IMPLANTS - ACRYLIC RESIN CEMENTS, FOR USE IN SURGERY
4 - PREFACE
4 - CONTENTS
5 - 1 SCOPE.
5 - 2 FIELD OF APPLICATION.
5 - 3 DEFINITIONS.
5 - 3.1 Unit pack
5 - 3.2 Doughing time
5 - 3.3 Setting time
5 - 3. 4 Exothermic temperature
5 - 3.5 Plasticity of dough
5 - 3.6 Indentation
5 - 3.7 Recovery
5 - 4 COMPOSITION.
5 - 4.1 Basic requirement.
5 - 4.2 Classification.
5 - 5 PHYSICAL REQUIREMENTS.
5 - 5.1 Liquid component.
5 - 5.2 Powder component.
5 - 5.3 Powder/ liquid mixture.
6 - 5.4 Cured polymer.
6 - 6 TEST SAMPLE.
6 - 7 METHODS OF TEST.
6 - 7.1 Test conditions.
6 - 7.2 Inspection.
6 - 7.3 Effect of storage at 60°C on liquid component.
6 - 7.4 Doughing time.
6 - 7.5 Exothermic temperature.
6 - 7.6 Setting time.
7 - 7.7 Plasticity of dough.
7 - 7.8 Compressive strength.
7 - 7.9 Indentation and Recovery.
7 - 8 PERMISSIBLE VARIATIONS IN QUANTITIES PACKAGED (CONTENTS).
8 - 9 PACKAGING.
8 - 9.1 Containers.
8 - 9.2 Accessibility for mixing.
8 - 10 LABELLING.
8 - 10.1 On the label.
8 - 10.2 On the product identification insert.
13 - APPENDIX A - METHOD OF TEST FOR STERILITY
13 - A1 SCOPE.
13 - A2 PRINCIPLE.
13 - A3 MEDIA AND APPARATUS.
13 - A3.1 Fluid thioglycollate medium.
13 - A3.2 Soybean-casein digest medium.
14 - A3.3 Membrane filtration apparatus.
14 - A4 TEST SAMPLE.
14 - A5 PROCEDURE.
14 - A6 CRITERIA FOR PASSING AND REPEAT TESTING.

Specifies composition, physical performance and packaging requirements for self-curing resins based on poly (methyl methacrylate) used for the fixation of internal orthopaedic endoprostheses or for use in neurosurgery. Test methods include doughing time, exothermic temperature, plasticity of dough, compressive strength and indentation and recovery.

This standard specifies composition, physical performance and packaging requirements for self-curing resins based on poly (methyl meth-acrylate) used for the fixation of internal orthopaedic endoprostheses or for use in neurosurgery.

Reconfirmed 1994