ASTM-D7661 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

ASTM-D7661 - 2023 EDITION - CURRENT
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Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
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Scope

1.1 This test method covers procedures used to detect a shift in physical properties of natural rubber latex (NRL) condoms after immersion in a personal lubricant. “Personal lubricants” are lubricants such as liquids or gels that are applied by the consumer at the time of condom use.

1.2 This test method does not attempt to address compatibility of lubricants applied to a condom at the time of manufacture (“manufacturer lubricants”). It shall be the responsibility of the condom manufacturer to verify the long-term stability (shelf life) of any manufacturer lubricant that is packaged within the individual condom wrapper. Other regulatory requirements may apply.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Significance and Use

4.1 Weakening of natural rubber latex is known to occur after contact with certain lubricants, particularly petroleum-based products.3,4 This procedure was developed as a screening method for lubricant manufacturers to determine whether or not a particular personal lubricant has a significant effect on the tensile and airburst properties of an NRL condom.

4.2 This test method is designed for use on NRL condoms that meet the criteria of Specification D3492 and can: (1) have a ring specimen cut in compliance with Appendix X1 of Specification D3492 and (2) be tested for burst properties in compliance with Annex A2 of Specification D3492.

4.3 This test method is not to be used to determine the safety of either the test lubricant or NRL condom. This test method is to be used only to determine if the tensile or airburst properties of the NRL condom have been significantly affected by the test lubricant.

Keywords

compatibility; latex; lubricants; natural rubber; thin film;

To find similar documents by ASTM Volume:

09.02 (Rubber Products, Industrial - Specifications and Related Test Methods; Gaskets; Tires)

To find similar documents by classification:

11.200 (Birth control. Mechanical contraceptives)

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Document Number

ASTM-D7661-23

Revision Level

2023 EDITION

Status

Current

Modification Type

Revision

Publication Date

Oct. 16, 2023

Document Type

Test Method

Page Count

16 pages

Committee Number

D11.40