ASTM D3492-16
Standard Specification for Rubber Contraceptives (Male Condoms)

Standard No.

ASTM D3492-16

Release Date

2016

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM D3492-16

Scope

1.1 This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. This specification does not cover the specifications for lubricants or other dressing materials that may be applied to condoms except as noted in 3.2.

1.2 This specification is intended to assist buyers in obtaining condoms of consistent quality. The safe and proper use of condoms is excluded from the scope of this specification.

1.3 The applicability of this specification is as a design guideline and a reference test specification. It is not intended to be a routine quality control specification for condom manufacturing operations.

1.4 The annexes in this specification include important information, such as that on apparatus or materials, that is a mandatory part of the specification but too detailed for inclusion in the main text.

1.5 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.

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 Regulatory bodies may require additional information, such as clinical data, to support the condom sizes subject to this standard.

1.8 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

ASTM D3492-16 Referenced Document

• ASTM D1076 Standard Specification for Rubber-Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
• ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
• ASTM D3767 Standard Practice for Rubber-Measurement of Dimensions
• ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
• ASTM D4483 Standard Practice for Determining Precision for Test Method Standards in the Rubber and Carbon Black Industries
• ASTM D573 Standard Test Method for Rubber-Deterioration in an Air Oven
• ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
• ISO 4074 Natural rubber latex male condoms - Requirements and test methods

ASTM D3492-16 history

• 2016 ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
• 2015 ASTM D3492-15 Standard Specification for Rubber Contraceptives (Male Condoms)
• 2014 ASTM D3492-14 Standard Specification for Rubber Contraceptives 40;Male Condoms41;
• 2008 ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)
• 2003 ASTM D3492-03 Standard Specification for Rubber Contraceptives (Male Condoms)
• 2002 ASTM D3492-02 Standard Specification for Rubber Contraceptives (Male Condoms)
• 1997 ASTM D3492-97 Standard Specification for Rubber Contraceptives (Male Condoms)