Safety and Effectiveness of Testing Female Condoms as per ISO 25841
Female condom is a device that prevents pregnancy and sexually transmitted diseases that can happen during intercourse. This device is gaining importance as it allows women to take control of their health and keep themselves safe. They no longer have to be dependent on their male partner to take responsibility of preventing infections, diseases and pregnancies.
Safety of female condoms
Female condoms are extremely safe as they adhere to standards prescribed by International Standard Organization (ISO). ISO has specified all the requirements that need to be fulfilled by the female condom manufacturers while undertaking their production process, under ISO 25841.
Parameters of testing female condoms
Test of the insertion and retention feature
Female condoms do not stay in place unless they have a good insertion feature. Some female condoms have a medical grade sponge in the upper end of the condom, some have an air bubble, some have a stick for insertion and some have a dissolving ring. These features help to place the condom correctly and keep it in place during its usage.
Test of Lubrication
In female condoms, both water based and oil based lubrications are used. Depending on the kind of lubricant, tests are conducted according to ISO 25841
Test of Dimensions
Female condoms have rings at both its ends. The dimensions of these condoms include the diameter of both the circular ends and the length of the condom. Tests are conducted to ensure each dimensions adheres to the specifications prescribed by ISO.
Test of Barrier Properties
Female condoms must provide effective barrier so as to prevent any kind of leakage of discharge. For that viral penetration studies are conducted where female condoms are subjected to a medium containing a virus. Only when to medium is not able to percolate through it, the condom is deemed fit for use.
Test of biocompatibility
Biocompatibility test determines the compatibility of the condoms with male and female genital organs. The condoms must not cause any allergy or hormonal changes in the persons using the product.
Test of Volume and pressure
Like male condoms female condoms too, should be able to sustain pressure and volume. Not just that, it must be able sustain weight and volume when there is friction in the surrounding.
Test for stability and shelf life
Stability and shelf life of female condoms are tested to ensure that condoms are fit for use for the entire time span between date of manufacturing and date of expiry.
Test for visible defects
There should not be any visible defects in the condoms like holes and breakages that could render it useless.
Testing female condoms on these parameters according to ISO 25841 can ensure that the product is safe for use. Female condoms adhering to ISO norms are 95 percent effective.