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 for 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 needs 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 lubrication 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 dimension 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 or discharge. For that viral penetration studies are conducted where female condoms are subjected to a medium containing virus. Only when medium is not able to percolate through it, the condom is considered fit for use.

  • Test of bio-compatibility

Bio-compatibility test determines the compatibility of condoms with male and female genital organs. The condoms must not cause any allergy or hormonal changes in the person 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 to 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 the date of manufacturing and the 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 to be 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

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