ISO 7439 pdf download – Copper-bearing intra-uterine contraceptive devices一Requirements, tests

ISO 7439 pdf download – Copper-bearing intra-uterine contraceptive devices一Requirements, tests.
4 Intended performance
4.1 General
The requirements of clause 4 of EN ISO 14630:1997 shall apply.
4.2 Clinical performance
For physical requirements see clause 5.
An IUD shall meet the following requirements for a period of 3 years (the minimum intended lifetime of use):
— pregnancy rate 2 per 100 woman years during the 1st year as calculated by life-table analysis;
— expulsion rate < 10 per 100 woman years dunng the 1st year as calculated by life-table analysis. 5 Design attributes 5.1 General The requrernents of clause 5 of EN ISO 14630:1997 shall app’y. Thread and copper shall be integral parts of the IUD. 5.2 Shape When tested by visual and tactile inspection an IUD shall have a form fitting the uterine cavity and designed in such a way as to minimize the risk of perforation and subsequent bowel obstruction. The IUDs and insertion instruments shall not exhibit sharp edges. The design of the IUD shall be such that no excessive forces are required for insertion and removal. 5.3 DImensions 5.3.1 IUD The nominal length of an IUD shall not be greater than 36 mm, the nominal width of an IUD shall not be greater than 32 mm. When determined as specified in 7.2.1. the dimensions shall be consistent with the specifications as given by the manufacturer within tolerances of ± 5 %. 5.3.2 Copper components The nominal active surface area of copper shall be at least 200 mm. but shall not be larger than 380 mm. If copper wire is used, the nominal diameter of the copper wire shall be at least 0,25 mm. 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) a force range of 0 N to 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 the 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 indude 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. a) IUD to be deformed poor to insertion The position of both arms, or those parts of the IUD that will be subjected to folding either before insertion or when inserting the IUD, shall be determined in relation to the rest of the IUD. The arms (or parts) of the IUD are folded according to the manufacturers instructions for application. They shall remain in this folded position for 5 mm and then be allowed to recover their shape under zero load tot’ 1 mm. b) IUD not to be deformed prior to insertion The entire IUD shall be inserted into a tube with an inner diameter of (10 ± 0,1) mm for a period of 5 mm and then removed and allowed to recover its shape under zero load for one minute. Determine the position of the arms or parts of the IUD that were subjected to folding. 7.4.3 Test report The test report shall include the following: a) identification of the sample: b) number of IUDs tested: C) for each IUD the displacement of any parts from their original position; d) date of testing. 7.5 Determination of barium sulphate content and identtfication of barium and sulphate a) Ash content test Ash content shall be determined by the European Pharmacopoeia sulphated ash method, but omit the use of sulphuric acid.