scope:

This document provides guidance on assessing the effect or compatibility of an additional or personal lubricant with synthetic male condoms (excluding synthetic polyisoprene condoms). It also applies to topical medicines and any other substances that come into contact with such condoms. It describes the measurement of changes in physical properties of the condoms after exposure to the test substance (i.e. lubricant, topical medicine, etc.) and specifies the pass/fail criteria for such changes.

This document is intended to be used for evaluating the compatibility of chosen additional lubricants or topical medicines with chosen synthetic condoms. Each lubricant type is evaluated specifically against each condom material for which compatibility is claimed.

This document is not applicable to the assessment of the compatibility of lubricants applied to a condom at the time of manufacture. It is not directly applicable to female condoms, although similar principles can apply.