1 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.