ASTM D7661 Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

ASTM D7661 describes how to identify a change in the physical characteristics of non-lubricated natural rubber latex (NRL) condoms after they've been exposed to a personal lubricant. The values are expressed in SI units.

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ASTM D7661 Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

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Overview
Scope, Applications, and Benefits
Test Process
Specifications
Instrumentation
Results and Deliverables

Overview

ASTM D7661 is a test method standard that helps determine the compatibility of personal lubricants with natural rubber latex (NRL) condoms. Some lubricants, especially petroleum-based ones, can compromise the strength of latex and the performance of condoms.

This test method evaluates whether a lubricant significantly affects the tensile and airburst strength of non-lubricated NRL condoms and condom rings after a specified test duration. The test method helps in ensuring the safety and performance of products.

Scope, Applications, and Benefits

Scope

ASTM D7661 is related to natural rubber latex condoms, natural rubber latex condom rings, and personal lubricants in liquid or gel form. This standard evaluates the effects of lubricant exposure on the mechanical and airburst properties of natural rubber latex condoms to check their compatibility and potential degradation.

This standard specifically evaluates the effects of lubricant exposure on the following properties:

– Force at break
– Elongation at break
– Airburst pressure
– Airburst volume

Applications

Compatibility evaluation of personal lubricants
Condom quality assurance programs
Regulatory compliance testing
Product development and formulation validation
Consumer safety verification
Comparative lubricant performance studies, a standardised

Benefits

Ensures condom structural integrity
Identifies harmful lubricant formulations
Protects end-user safety
Supports regulatory submissions
Provides standardized compatibility assessment
Improves product reliability and performance consistency

Test Process

Conditioning & Immersion

Condoms/rings are conditioned at 40 °C and immersed in lubricant at body temperature for 60 minutes.

Cleaning

Samples are removed and excess lubricant is carefully wiped off.

Mechanical & Airburst Testing

Force at break, elongation, burst pressure, and burst volume are measured.

Validation & Comparison

Results are compared with baseline, untreated controls, and mineral oil–exposed samples.

Technical Specifications

Parameter	Details
Conditioning Temperature	40°C
Immersion Duration	60 minutes
Applicable Materials	Natural rubber latex condoms and rings
Lubricant Types	Liquid and gel personal lubricants
Measured Properties	Breaking force (N), elongation at break (%), burst pressure (kPa), burst volume (L)
Output Units	N, %, kPa, L
Data Analysis	Mean and standard deviation for each sample group

Instrumentation Used for Testing

Universal tensile testing machine
Airburst testing apparatus
Temperature-controlled conditioning chamber
Precision measurement instruments
Laboratory immersion containers
Data acquisition and analysis software

Results and Deliverables

Mean and standard deviation of breaking force
Mean and standard deviation of elongation at break
Mean and standard deviation of burst pressure
Mean and standard deviation of burst volume
Comparative analysis against control groups
Compatibility assessment report
Regulatory compliance report

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Frequently Asked Questions

ASTM D7661 describes a test to evaluate whether a personal lubricant damages the tensile strength and airburst resistance of natural rubber latex condoms.

Some lubricants, particularly petroleum-based ones, may degrade latex. This compatibility test is performed to ensure that lubricants do not compromise the strength or safety of condoms.

In the test, condoms and rings are pre-conditioned at 40°C and exposed to the lubricant for 60 minutes at body temperature conditions.

This standard applies to liquid and gel personal lubricants used with condoms.

The scope applies only to natural rubber latex condoms and condom rings.