ISO 25841:2017
Female condoms — Requirements and test methods

Standard No.
ISO 25841:2017
Release Date
2017
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 25841:2017/Amd 1:2020
Latest
ISO 25841:2017/Amd 1:2020
Scope
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

ISO 25841:2017 history

Female condoms — Requirements and test methods



Copyright ©2024 All Rights Reserved