scope:

This document gives the essential principles in the application of ISO 25841. It outlines the details of elements applicable in quality management of female condoms as required by related normative standards, as referred in ISO 25841 and other relevant concepts.

This document supplements the use of ISO 25841 and addresses quality management aspects to be considered during the development, manufacture, quality verification and procurement of female condoms. It encompasses the principles of quality management systems in design, manufacture, and delivery of female condoms with emphasis on their performance, safety and reliability.

This document is applicable to female condoms made of natural rubber or synthetic rubber or synthetic polymers and the retention devices which form the integral components of female condoms.

NOTE Female condoms made from either natural rubber latex or synthetic rubber or other synthetic polymeric materials are addressed in ISO 25841.