ISO/TR 24484:2023

Female condoms — Use of ISO 25841 and the quality management of female condoms

Female condoms — Use of ISO 25841 and the quality management of female condoms

Digital Document2023 edition2023Purchase Options

Referenced standards

ISO 13485ISO 14971ISO 25841ISO 2859-1ISO 29943-2ISO 9000ISO/IEC 17025
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ISO/TR 24484:2023

Female condoms — Use of ISO 25841 and the quality management of female condoms

Female condoms — Use of ISO 25841 and the quality management of female condoms

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.

Edition2023
Published Date2023
Published ByInternational Standardization Organisation/Technical Reference
Page Count13