ISO 7439:2002 pdf download

ISO 7439:2002 pdf download.Copper-bearing intra-uterine contraceptive devices — Requirements, tests.
5.3.4 Insertion instrument
The maximum nominal outer width of the part of an insertion instrument intended to come into contact with the cervical canal shall not be greater than 5 mm.
The dimensions shall be consistent with the specifications as given by the manufacturer within tolerances of ± 5 %.
5.4 Tensile force
When tested in accordance with 7.3 the IUD, including the thread, shall withstand a tensile force of at least 12 N.
5.5 Stability
5.5.1 Shelf-life stability
The IUD shall meet any performance specification given by the manufacturer for the complete duration of the declared
shelf-life.
5.5.2 In situ stability
During its intended period of use the copper components shall retain structural integrity and the entire IUD shall withstand the tensile force according to 5.4.
5.6 Visco-elastic property
When tested in accordance with 7.4 the recovery of any part of the IUD from its original design position shall be such that the residual deformation does not exceed 5 mm.
5.7 In situ detection
All parts of the IUD frame shall be detectable by X-ray examinations. If barium sulphate is used in the plastics components as the opaque material its content shall range from 15% (w/w) to 25% (w/w), when tested as specified in
7.5.
6 Materials
The requirements of clause 6 of EN ISO 14630:1 997 shall apply.
The plastics body including the substance conferring radio-opacity shall be visco-elastic, biocompatible and non-absorbable.
The thread shall be monofilament, biocompatible and non-absorbable.
The purity of the copper shall be at least 99,9 % which shall be certified.
7 Design evaluation
7.1 General
The requirements of 7.1 of EN ISO 14630:1 997 shall apply.
7.2 Determination of dimensions
7.2.1 For determining the dimensions of the IUD and the outer diameter of the insertion instrument a method that does not alter the shape, e.g. a contour analyzer or any other instrument providing similar accurate results, shall be used.
7.2.2 For determining the length of the thread a ruler or any other instrument providing similar accurate results shall be used.
7.2.3 The active surface area shall be computed using mathematical formulas.
7.3 Determination of tensile force
7.3.1 Principle
The IUD including the thread is stretched until breakage of the IUD or detachment or breakage of the thread occurs.
The force required to cause breakage is measured.
7.3.2 Apparatus
Tensile testing machine capable of a substantially constant rate of traverse and complying with the following
requirements:
a)aforce range ofONto 100 N;
b) a separation speed of (3,3 ± 0,3) mm/s or (200 ± 20) mm/mm;
c) automatic recording of force applied during test; a chart recorder may be used.
7.3.3 Procedure
The test method shall be designed in such a way that the potentially weakest part of the IUD is exposed to we tensile force.
The IUD shall be conditioned at a temperature of (23 ± 2) oC and relative humidity of (50 ± 5) % for at least 24 h. Each IUD is placed into the tensile testing machine according to the manufacturer’s instructions, If no instructions are supplied by the manufacturer, the upper part of the IUD is placed in the upper clamp with thread(s) placed in the lower clamp at a distance of 5 cm from its point of attachment to the IUD. Force is then applied and the IUD is stretched until either it or the thread breaks or detaches. The force at break or detachment is measured and recorded.
7.3.4 Test report
The test report shall include the following:
a) identification of the sample;
b) number of IUDs tested;
C) breaking force, in newtons, of each IUD;
d) position of the break;
e) date of testing.
7.4Test of visco-elastic property (memory-test)7.4.1 Principle
The visco-elastic property of the lUDs is tested by determining the recovery after acute flexion.7.4.2 Procedure
The lUD is conditioned at a temperature of (23±2)C and relative humidity of (50 ± 5) % for at least 24 h.Depending on whether or not the lUD is to be deformed prior to insertion, the test shall be performed as follows:a)lUD to be deformed prior to insertion.