Overview
ISO/TS 23148:2024 - Compatibility of lubricants with synthetic male condoms - is a technical specification that provides guidance for evaluating how additional or personal lubricants, topical medicines, and other substances affect the physical properties of synthetic male condoms (excluding synthetic polyisoprene). The document describes laboratory methods to measure changes in tensile and inflation (airburst) properties after controlled exposure and specifies pass/fail criteria for compatibility claims.
Key topics and requirements
- Scope: Tests apply to additional/personal lubricants, topical medicines and other substances that may contact synthetic condoms in use. Not applicable to lubricants applied during manufacture or directly to female condoms (though similar principles may apply).
- Test principle: Measure changes in tensile properties and inflation (airburst) after 60 minutes exposure at body temperature (recommend 3 hours for female condoms if considered).
- Sample types:
- Rings cut from condoms for tensile testing (force and elongation at break - see Annex A).
- Whole condom areas relevant to inflation testing per ISO 23409.
- Controls:
- Negative control (e.g., distilled water where suitable).
- Benchmark control (substance that causes minimal, acceptable change).
- Positive control (known to cause deterioration).
- Pass/fail criteria: Specified statistical comparisons of treated vs control groups; Annex B covers confidence-interval calculation for ratio of two means.
- Apparatus and procedure: Test apparatus and methods align with ISO 19671; includes sample size, quantity of test substance, cleaning, heating to body temperature, and standardized inflation/tensile test execution.
- Limitations: The method evaluates physical compatibility (tensile/airburst) only and does not determine clinical safety or predict all in-use failures. Results are specific to the tested condom product and lubricant combination unless material equivalence is demonstrated.
Practical applications and users
ISO/TS 23148:2024 is intended for:
- Lubricant manufacturers - to substantiate compatibility claims for specific synthetic condom materials.
- Condom manufacturers - to qualify third‑party lubricants and topical medicines for use with their products.
- Independent test laboratories - to perform standardized compatibility testing (tensile and inflation).
- Regulatory bodies and QA teams - for product evaluation, labeling support and risk assessment during product development or market surveillance.
- R&D and product developers - to screen formulations (including volatile silicone fractions like Cyclomethicone D5 mentioned in the introduction) that may transiently affect condom strength.
Related standards
- ISO 23409 - Male condoms: requirements and inflation test methods for synthetic materials
- ISO 19671 - Additional lubricants for natural rubber latex condoms (comparative approach)
- ISO 4074 - Natural rubber latex male condoms - requirements and test methods
Keywords: ISO/TS 23148:2024, compatibility of lubricants with synthetic male condoms, lubricant compatibility testing, tensile testing, inflation (airburst) testing, topical medicines, condom material compatibility, pass/fail criteria.