BS ISO 5833:2002

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Implants for surgery. Acrylic resin cements

Published By	Publication Date	Number of Pages
BSI	2002	30

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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Description

This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.

This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement. All

requirements apply to, and all tests are intended to be performed on, the sterile product.

PDF Catalog

PDF Pages	PDF Title
3	TitlePage – Implants for surgery�— Acrylic resin cements
5	TableofContent – Contents Page
6	Foreword – Foreword
7	Scope – 1�� Scope Clause1 – 3�� Liquid component Subclause2 – 3.1�� Appearance Subclause2 – 3.2�� Stability Subclause2 – 3.3�� Accuracy of contents
8	Clause1 – 4�� Powder component Subclause2 – 4.1�� General Subclause2 – 4.2�� Appearance Subclause2 – 4.3�� Accuracy of contents Clause1 – 5�� Liquid-powder mixture intended for syringe usage
9	Clause1 – 6�� Liquid-powder mixture intended for use in dough state Subclause2 – 6.1�� Setting properties, test methods and requirements Subclause2 – 6.2�� Intrusion Clause1 – 7�� Set and polymerized cement Clause1 – 8�� Packaging 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 Subclause2 – 9.1�� Unit package
10	Subclause2 – 9.2�� Accompanying documentation
11	AnnexNormative – Determination of stability of liquid component Clause1 – A.1�� Principle Clause1 – A.2�� Apparatus 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 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
12	Clause1 – A.6�� Test report
13	AnnexNormative – Determination of doughing time of liquid-powder mixture of cement intended for d… Clause1 – B.1�� Principle Clause1 – B.2�� Apparatus 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 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
14	Clause1 – B.6�� Test report
15	AnnexNormative – Determination of maximum temperature and setting time of liquid-powder mixture Clause1 – C.1�� Principle Clause1 – C.2�� Apparatus 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 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�
16	Clause1 – C.5�� Calculation and expression of results Subclause2 – C.5.1�� Maximum temperature 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 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
19	AnnexNormative – Determination of intrusion of liquid-powder mixture of cement intended for dough… Clause1 – D.1�� Principle Clause1 – D.2�� Apparatus 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 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 – 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
20	Clause1 – D.5�� Test report
21	AnnexNormative – Determination of compressive strength of polymerized cement Clause1 – E.1�� Principle Clause1 – E.2�� Apparatus 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 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
22	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
25	AnnexNormative – Determination of bending modulus and bending strength of polymerized cement Clause1 – F.1�� Principle Clause1 – F.2�� Apparatus 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 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…
26	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 Subclause2 – F.5.1�� Bending modulus
27	Subclause2 – F.5.2�� Bending strength Clause1 – F.6�� Test report

Additional information

Status	Confirmed
Pages	30
Publication Date	2002-06-24
ISBN	0 580 39219 8
Standard Number	BS ISO 5833:2002
Title	Implants for surgery. Acrylic resin cements
Identical National Standard Of	ISO 5833:2002
Replaces	BS 7253-1:1993
Descriptors	Surgical equipment, Marking, Orthopaedic equipment, Prosthetic devices, Cements, Acrylic resins, Implants (surgical), Orthopaedics, Packaging
Publisher	BSI
Committee	CH/150/1
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BS ISO 5833:2002

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