This document specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).
ISO 25841:2017 Referenced Document
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*, 2018-08-01 Update
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice*, 2020-09-01 Update
ISO 14971 Medical devices - Application of risk management to medical devices*, 2019-12-01 Update
ISO 2859-1:1999 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 29943-2 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-reports
ISO 4074 Natural rubber latex male condoms - Requirements and test methods