ISO 23409:2011 PDF

Scope: This International Standard specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.

ISO 23409:2011 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 15223 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
ISO 16037 Rubber condoms for clinical trials — Measurement of physical properties AMENDMENT 1
ISO 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1
ISO 4074 Natural rubber latex male condoms - Requirements and test methods*， 2015-10-01 Update
ISO/TR 8550 Guide for the selection of an acceptance sampling system, scheme or plan for inspection of discrete items in lots

2011 ISO 23409:2011 Male condoms - Requirements and test methods for condoms made from synthetic materials