ISO 16402:2008
(Main)Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics
Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics
ISO 16402:2008 applies to resin cements based on poly(methacrylic acid esters) and specifies the procedure for determining the fatigue behaviour of the polymerized cement.
Implants chirurgicaux — Ciment à base de résine acrylique — Essais de fatigue flexurale des ciments à base de résine acrylique utilisés en orthopédie
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 16402
First edition
2008-05-15
Implants for surgery — Acrylic resin
cement — Flexural fatigue testing of
acrylic resin cements used in
orthopaedics
Implants chirurgicaux — Ciment à base de résine acrylique — Essais de
fatigue flexurale des ciments à base de résine acrylique utilisés en
orthopédie
Reference number
ISO 16402:2008(E)
©
ISO 2008
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ISO 16402:2008(E)
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ISO 16402:2008(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 16402 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials.
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INTERNATIONAL STANDARD ISO 16402:2008(E)
Implants for surgery — Acrylic resin cement — Flexural fatigue
testing of acrylic resin cements used in orthopaedics
1Scope
This International Standard applies to resin cements based on poly(methacrylic acid esters) and specifies the
procedure for determining the fatigue behaviour of the polymerized cement.
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 5833:2002, Implants for surgery — Acrylic resin cements
ISO 16428, Implants for surgery— Test solutions and environmental conditions for static and dynamic
corrosion tests on implantable materials and medical devices
3 Test method
The tests make use of rectangular bar-shaped test specimens. The method for preparing these specimens is
described in Clause 5.
The bending strength of the resulting test specimens is determined by means of a four-point bend test under
quasi static and cyclic loading conditions. Under cyclic loading conditions two test methods are described. The
first one follows the Wöhler method (S/N curve method) and determines the behaviour over the full range
...
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