STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES *** W/D S/S BY AAMI 11135 ***
This International Standard specifies a method for determining
the compressive properties of plastics under defined conditions. A
standard test specimen is defined but its length may be adjusted to
prevent buckling under load from affecting the results. A range of
test speeds is included.
The method is used to investigate the compressive behaviour of
the test specimens and for determining the compressive strength,
compressive modulus and other aspects of the compressive
stress/strain relationship under the conditions defined.
The method applies to the following range of materials:
- rigid and semi-rigid thermoplastic moulding and
extrusion materials, including compounds filled and reinforced by
e.g. short fibres, small rods, plates or granules in addition to
unfilled types; rigid and semi-rigid thermoplastic sheet;
- rigid and semi-rigid thermoset moulding materials,
including filled and reinforced compounds; rigid and semi-rigid
- thermotropic liquid-crystal polymers.
In agreement with ISO 10350-1 and ISO 10350-2, this
International Standard applies to fibre-reinforced compounds with
fibre lengths < 7,5 mm prior to processing.
The method is not normally suitable for use with materials
reinforced by textile fibres (see references  and ),
fibre-reinforced plastic composites and laminates (see ), rigid
cellular materials (see ) or sandwich structures containing
cellular material or rubber (see ).
The method is performed using specimens which may be moulded to
the chosen dimensions, machined from the central portion of a
standard multipurpose test specimen (see ISO 3167) or machined from
finished or semi-finished products such as moulding or extruded or
The method specifies preferred dimensions for the test
specimen. Tests which are carried out on specimens of different
dimensions, or on specimens which are prepared under different
conditions, may produce results which are not comparable. Other
factors, such as the test speed and the conditioning of the
specimens, can also influence the results. Consequently, when
comparable data are required, these factors must be carefully
controlled and recorded.
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