What is this standard about?
It specifies requirements and test methods for male condoms made from natural rubber latex and supplied to consumers for contraceptive purposes and to assist in the prevention of sexually transmitted infections (STIs).
Who is this standard for?
- Condom manufacturers
- Regulatory agencies
- Notified bodies
- Condom purchasers
Why should you use this standard?
To ensure that condoms are effective for contraceptive purposes and in helping prevent the transmission of STIs, they must fit the penis properly, be free from holes, have adequate physical strength so as not to break during use, be packaged to protect them during storage, and be correctly labelled to facilitate their use. This standard covers all these issues. In addition use of this standard provides one means of conforming to essential requirements in the New Approach Medical Devices Directive 93/42/EEC.
What’s changed since the last update?
This third edition cancels and replaces the second edition which has been technically revised. Modifications include the following:
- The maximum lot size has been limited to 500,000
- Specific requirements for biocompatibility assessments have been added
- It is recommended that manufacturers establish procedures for periodic monitoring of microbial contamination (bioburden) as part of their quality management system
- Specific requirements for extra strength condoms have been deleted and additional claims must be clinically substantiated
- A minimum airburst volume has been introduced for mid-body width condoms
- The radius of the inner edge of the clamping collar wherever it contacts the inflated condom has to be a minimum of 2 mm
- Several elements of the freedom from holes test have been modified
- Amendments have been made to the methods for determining the shelf life of condoms
- The procedure for determining the thickness of a condom by the micrometer method is described in detail
- An alternative method of removing the lubricant from the condom using an aqueous surfactant solution has been introduction into the method for determining the amount of lubricant on the condom
- Revisions have been made to labelling requirements