ISO 4074:2015 for Natural rubber latex male condoms testing
What are condoms?
Condoms are medical devices and method of contraception that can both prevent pregnancy
and protect against sexually transmitted infections (STIs). Condoms are a “barrier” method of
contraception. They are made of very thin latex (rubber), polyurethane or polyisoprene and are
designed to prevent pregnancy and STIs.
STIs caused by Human immunodeficiency virus (HIV), other infectious organisms, and
spermatozoa have all been demonstrated to be resistant to male latex condoms produced from
intact latex film.
In order to help ensure that condoms are effective for contraceptive purposes and in assisting in
the prevention of transmission of STIs, it is essential that condoms fit the penis properly, are
free from holes, have adequate physical strength so as not to break during use, are correctly
packaged to protect them during storage, and are correctly labelled to facilitate their use.
To ensure high quality products, it is essential that condoms are produced under a good quality
management system. ISO 13485 is required for quality management requirements and ISO
14971 is required for risk management requirements. Condoms might be subject to specific
local requirements as required by national regulatory bodies in addition to those specified in this
ISO Standard for male latex condoms
Manufacturers are required by the International Standard to conduct stability experiments to predict the shelf life of each new or modified condom before it is placed on the market, as well as to begin real-time stability research. ISO 4074 is overseen by ISO/TC 157, which is responsible for non-systemic contraceptives and STI barrier prophylactics.
Condoms are non-sterile medical devices, although manufacturers are recommended to take reasonable steps to prevent microbial contamination throughout the production and packing procedures. ISO 4074:2015 includes recommendations for producers to check microbiological contamination during production on a regular basis.
The third edition (ISO 4074:2015) replaces the second edition (ISO 4074:2014), which has been technically revised. The modifications are as follows:
● The maximum lot size has been limited to 500 000.
● Specific requirements for biocompatibility assessments, as defined in ISO 10993-1, have been added.
● It is recommended that manufacturers establish procedures for the periodic monitoring of microbial contamination (bioburden) as part of their quality management system.
● A minimum airburst volume of 28,0 dm3 has been introduced for condoms with mid-body widths that are greater than or equal to 65,0 mm and not more than 75,0 mm.
● The radius of the inner edge of the clamping collar wherever it contacts the inflated condom has to be a minimum of 2 mm.
● Amendments have been made to the methods for determining the shelf life of condoms including a simplified procedure for determining the shelf life by accelerated stability
studies based on fixed ageing periods at 50 °C.
● Testing for freedom from holes, airburst properties, and package integrity are required
when conducting stability studies to establish that condoms meet the minimum stability
requirements specified in this International Standard when determining condom shelf
● Revisions have been made to labelling requirements including the additional information
supplied with the condom.
Importance of Condom Testing
It is important to test condoms to ensure the quality and usage of condom is good, accurate and
fulfils their purpose in avoiding unwanted pregnancies and transmission of STDs (Sexually
Transmitted Diseases) and infections. Therefore, it is very important for manufacturers to get
their condom products tested for quality and safety against the ISO standards to stay in-
compliance and for customers to use only tested products to ensure safety.
Are you a manufacturer of male condom products?
Get in touch with Sigma Test and Research Centre to be in compliance with the standards set
by the International Standard Organization (ISO) by getting condom testing done. Call us at +91
– 95 60 222 333 or fill out the enquiry form here.
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