ASTM D6324-11(2023)
Standard Specification for Male Condoms Made from Polyurethane

Standard No.

ASTM D6324-11(2023)

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM D6324-11(2023)

Scope

1.1 This specification covers the minimum requirements for individually packaged male condoms made from polyurethane. This specification also describes the minimum inspection and quality levels that shall be utilized in referee tests. It is not intended to be a routine quality control specification for polyurethane condom manufacturing operations. 1.2 This specification is intended to assist buyers in obtaining male polyurethane condoms of consistent quality. The safe and proper use of male polyurethane condoms is excluded from the scope of these test methods. 1.3 The annexes in these test methods include important information, such as that on apparatus or materials, that are a mandatory part of these test methods but too detailed for inclusion in the main text. 1.4 The appendixes in these test methods contain information intended to provide guidance. 1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.6 It shall be the responsibility of the manufacturer for any condom design that falls outside the specifications of this standard to determine testing methodology and substantiate the appropriateness of that methodology to assure the quality of the condoms to the purchaser and to the government regulatory authority having jurisdiction. 1.7 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. 1.8 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.

ASTM D6324-11(2023) Referenced Document

• ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
• ASTM D3492 Standard Specification for Rubber Contraceptives (Male Condoms)
• ASTM D374 Standard Test Methods for Thickness of Solid Electrical Insulation
• ASTM D3767 Standard Practice for Rubber-Measurement of Dimensions
• ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
• ASTM D618 Standard Practice for Conditioning Plastics for Testing
• ASTM D638 Standard Test Method for Tensile Properties of Plastics
• ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
• ISO 23409 Male condoms - Requirements and test methods for condoms made from synthetic materials
• ISO 37 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties

ASTM D6324-11(2023) history

• 2023 ASTM D6324-11(2023) Standard Specification for Male Condoms Made from Polyurethane
• 2011 ASTM D6324-11(2017) Standard Specification for Male Condoms Made from Polyurethane
• 2011 ASTM D6324-11 Standard Test Methods for Male Condoms Made from Polyurethane
• 2008 ASTM D6324-08 Standard Test Methods for Male Condoms Made from Polyurethane
• 2005 ASTM D6324-05 Standard Test Methods for Male Condoms Made from Synthetic Materials
• 1999 ASTM D6324-99a(2004) Standard Test Methods for Male Condoms Made from Synthetic Materials
• 1999 ASTM D6324-99a Standard Test Methods for Male Condoms Made from Synthetic Materials
• 1999 ASTM D6324-99 Standard Test Methods for Male Condoms Made from Synthetic Materials