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ISO 5833:2002 Implants for surgery - Acrylic resin cements, 2002
- TitlePage - Implants for surgery— Acrylic resin cements
- TableofContent - Contents Page
- Foreword - Foreword [Go to Page]
- Scope - 1 Scope
- Clause1 - 3 Liquid component [Go to Page]
- Subclause2 - 3.1 Appearance
- Subclause2 - 3.2 Stability
- Subclause2 - 3.3 Accuracy of contents
- Clause1 - 4 Powder component [Go to Page]
- Subclause2 - 4.1 General
- Subclause2 - 4.2 Appearance
- Subclause2 - 4.3 Accuracy of contents
- Clause1 - 5 Liquid-powder mixture intended for syringe usage
- Clause1 - 6 Liquid-powder mixture intended for use in dough state [Go to Page]
- Subclause2 - 6.1 Setting properties, test methods and requirements
- Subclause2 - 6.2 Intrusion
- Clause1 - 7 Set and polymerized cement
- Clause1 - 8 Packaging [Go to Page]
- UntitledSubclause2 - 8.1 Each component of the cement shall be packaged and sterilized separat...
- UntitledSubclause2 - 8.2 In the case of cement being sold with two cement units per container,...
- UntitledSubclause2 - 8.3 The materials of the package should not contaminate or permit contami...
- Clause1 - 9 Labelling [Go to Page]
- Subclause2 - 9.1 Unit package
- Subclause2 - 9.2 Accompanying documentation
- AnnexNormative - Determination of stability of liquid component [Go to Page]
- Clause1 - A.1 Principle
- Clause1 - A.2 Apparatus [Go to Page]
- UntitledSubclause2 - A.2.1 Clean glass U-tube viscometer
- UntitledSubclause2 - A.2.2 Timing device
- UntitledSubclause2 - A.2.3 Means of heating test specimens
- Clause1 - A.3 Test conditions
- Clause1 - A.4 Procedure [Go to Page]
- UntitledSubclause2 - A.4.1 Fill the viscometer in the usual way with the liquid component.
- UntitledSubclause2 - A.4.2 Record the flow time taken for the meniscus to fall to the equilibr...
- UntitledSubclause2 - A.4.3 Heat an aliquot of the liquid component at
- UntitledSubclause2 - A.4.4 Repeat
- UntitledSubclause2 - A.4.5 Repeat
- Clause1 - A.5 Calculation and expression of results
- Clause1 - A.6 Test report
- AnnexNormative - Determination of doughing time of liquid-powder mixture of cement intended for d... [Go to Page]
- Clause1 - B.1 Principle
- Clause1 - B.2 Apparatus [Go to Page]
- UntitledSubclause2 - B.2.1 Timing device
- UntitledSubclause2 - B.2.2 Unpowdered latex surgical gloves
- UntitledSubclause2 - B.2.3 Equipment
- Clause1 - B.3 Test conditions
- Clause1 - B.4 Procedure [Go to Page]
- UntitledSubclause2 - B.4.1 Mix all the components of a single unit of cement following the man...
- UntitledSubclause2 - B.4.2 After approximately
- UntitledSubclause2 - B.4.3 Repeat the probing process at maximum intervals of
- UntitledSubclause2 - B.4.4 Repeat the process described in
- UntitledSubclause2 - B.4.5 If the two doughing times differ by more than
- Clause1 - B.5 Calculation and expression of results
- Clause1 - B.6 Test report
- AnnexNormative - Determination of maximum temperature and setting time of liquid-powder mixture [Go to Page]
- Clause1 - C.1 Principle
- Clause1 - C.2 Apparatus [Go to Page]
- UntitledSubclause2 - C.2.1 Mould and plunger
- UntitledSubclause2 - C.2.2 Device
- UntitledSubclause2 - C.2.3 C-clamp
- UntitledSubclause2 - C.2.4 Timing device
- UntitledSubclause2 - C.2.5 Equipment
- Clause1 - C.3 Test conditions
- Clause1 - C.4 Procedure [Go to Page]
- UntitledSubclause2 - C.4.1 Record the ambient temperature from the thermocouple in the mould.
- UntitledSubclause2 - C.4.2 Mix all the components of a single unit of cement following the man...
- UntitledSubclause2 - C.4.3 Start the timing device as soon as the powder and liquid come into ...
- UntitledSubclause2 - C.4.4 Fill the mould with approximately
- UntitledSubclause2 - C.4.5 Continue the temperature measurement until shortly after the temper...
- UntitledSubclause2 - C.4.6 Repeat
- UntitledSubclause2 - C.4.7 If the two maximum temperatures (see
- Clause1 - C.5 Calculation and expression of results [Go to Page]
- Subclause2 - C.5.1 Maximum temperature [Go to Page]
- UntitledSubclause3 - C.5.1.1 For each unit of cement, plot the recorded temperatures against t...
- UntitledSubclause3 - C.5.1.2 Calculate the average value for the two or four determinations. R...
- Subclause2 - C.5.2 Setting time [Go to Page]
- UntitledSubclause3 - C.5.2.1 For each unit of cement, determine from the plot made in
- UntitledSubclause3 - C.5.2.2 Record the value of
- Clause1 - C.6 Test report
- AnnexNormative - Determination of intrusion of liquid-powder mixture of cement intended for dough... [Go to Page]
- Clause1 - D.1 Principle
- Clause1 - D.2 Apparatus [Go to Page]
- UntitledSubclause2 - D.2.1 Mould and plunger
- UntitledSubclause2 - D.2.2 Means of applying a compressive force
- UntitledSubclause2 - D.2.3 Means of measuring
- UntitledSubclause2 - D.2.4 Equipment
- Clause1 - D.3 Test conditions
- Clause1 - D.4 Procedure [Go to Page]
- UntitledSubclause2 - D.4.1 Mix all the components of a single unit of cement, following the ma...
- UntitledSubclause2 - D.4.2 By means of the procedure given in
- UntitledSubclause2 -
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- UntitledSubclause2 - D.4.4 Remove the set cement from the mould and measure the extent of intr...
- UntitledSubclause2 - D.4.5 If the average intrusion is less than
- Clause1 - D.5 Test report
- AnnexNormative - Determination of compressive strength of polymerized cement [Go to Page]
- Clause1 - E.1 Principle
- Clause1 - E.2 Apparatus [Go to Page]
- UntitledSubclause2 - E.2.1 Mould
- UntitledSubclause2 - E.2.2 C-clamp
- UntitledSubclause2 - E.2.3 24-mesh silicon carbide grinding abrasive
- UntitledSubclause2 - E.2.4 Mould release agent
- UntitledSubclause2 - E.2.5 Equipment
- UntitledSubclause2 - E.2.6 Test machine
- Clause1 - E.3 Test conditions
- Clause1 - E.4 Procedure [Go to Page]
- UntitledSubclause2 - E.4.1 If required, lightly coat the interior faces of the mould and the i...
- UntitledSubclause2 - E.4.2 Place the mould on one end plate.
- UntitledSubclause2 - E.4.3 Mix all the components of a single unit of cement, following the ma...
- UntitledSubclause2 - E.4.4 For cements intended for dough usage, determine when the doughing t...
- UntitledSubclause2 - E.4.5 Clamp the end plates and the mould together and allow the cement to...
- UntitledSubclause2 - E.4.6 If using the mould shown in
- UntitledSubclause2 - E.4.7 If using another type of mould, grind the cement cylinders so as to...
- UntitledSubclause2 - E.4.8 Condition the cylinders at
- UntitledSubclause2 - E.4.9 At
- UntitledSubclause2 - E.4.10 Repeat
- Clause1 - E.5 Calculation and expression of results
- Clause1 - E.6 Test report
- AnnexNormative - Determination of bending modulus and bending strength of polymerized cement [Go to Page]
- Clause1 - F.1 Principle
- Clause1 - F.2 Apparatus [Go to Page]
- UntitledSubclause2 - F.2.1 Bend test machine
- UntitledSubclause2 - F.2.2 Four-point bend test rig
- UntitledSubclause2 - F.2.3 Moulds
- UntitledSubclause2 - F.2.4 Flat
- UntitledSubclause2 - F.2.5 Polyester film
- UntitledSubclause2 - F.2.6 C-clamp(s)
- UntitledSubclause2 - F.2.7 Equipment
- Clause1 - F.3 Test conditions
- Clause1 - F.4 Procedure [Go to Page]
- UntitledSubclause2 - F.4.1 Cover the bottom plate(s) of the mould(s) with polyester film. Plac...
- UntitledSubclause2 - F.4.2 Mix all the components of a single unit of cement, following the ma...
- UntitledSubclause2 - F.4.3 For cements intended for dough usage, determine when the doughing t...
- UntitledSubclause2 - F.4.4 After approximately
- UntitledSubclause2 - F.4.5 Take care to avoid overheating the test specimens. Wet-grind the ed...
- UntitledSubclause2 - F.4.6 Measure the specimen thickness and width to an accuracy of
- UntitledSubclause2 - F.4.7 By means of the bend test machine, increase the force on the centra...
- UntitledSubclause2 - F.4.8 Record the deflection occurring at applied forces of
- UntitledSubclause2 - F.4.9 Repeat
- Clause1 - F.5 Calculation and expression of results [Go to Page]
- Subclause2 - F.5.1 Bending modulus
- Subclause2 - F.5.2 Bending strength
- Clause1 - F.6 Test report [Go to Page]
