ASTM-D6324 2011

$44.96

D6324-11 Standard Test Methods for Male Condoms Made from Polyurethane

Published By	Publication Date	Number of Pages
ASTM	2011	13

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Categories: 83.140.99 - Other rubber and plastics products, ASTM

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Description

1.1 These test methods cover and shall be used to evaluate male condoms made only of polyurethane. These test methods also describe 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 These test methods are intended to assist buyers in obtaining polyurethane condoms of consistent quality. The safe and proper use of 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 is 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 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 and health practices and determine the applicability of regulatory limitations prior to use.

A1.1.1 This annex covers the method for determining the length of polyurethane male condoms.

A2.1.1 This appendix covers the test method for determining the tensile properties of polyurethane condoms. Specimen elongation may be measured by extension indicators or displacement of gauge marks.

A4.1.1 Experience has shown that the water leakage test is most sensitive when the condom is filled while hanging vertically, its top is closed off, and the condom is placed in a horizontal position while it is examined for leaks. With this technique, the internal pressure over the entire condom surface is approximately uniform.

X1.1.1 This appendix covers the methods for determining the thickness of polyurethane male condoms.

X2.1.1 This appendix outlines a test method for determining the bursting volume and bursting pressure of polyurethane condoms. This test method is patterned after standard methods typically used in determining the air inflation properties of latex condoms. The testing apparatus and the procedure may not be appropriate for all types of polyurethane materials and product designs, and, therefore, it is inappropriate to establish a minimum requirement for volume.

X2.1.2 Following a more extensive review of existing and proposed polyurethane condom products, it may be more appropriate to categorize the marketed products by material type and design, and to develop separate test methods for each, after which, appropriate minimum requirements for volume can be established, consistent with the physical properties of the individual material types.

X3.1.1 This appendix covers the test method for determining the strength of welded seams of polyurethane condoms.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Significance and Use
2	Materials and Manufacture Requirements TABLE 1
3	Labeling Storage Condom Material and Clinical Validation
4	A1. DETERMINATION OF LENGTH A1.1 Scope A1.2 Principles A1.3 Apparatus A1.4 Procedure A1.5 Report A1.6 Condom Disposal
5	FIG. A1.1
6	A2. TEST METHOD FOR TENSILE PROPERTIES OF POLYURETHANE CONDOMS BY THE DUMBBELL METHOD A2.1 Scope A2.2 Significance and Use A2.3 Apparatus A2.4 Speed of Testing A2.5 Procedure A2.6 Calculation A2.7 Report
7	A3. PREPARATION AND TESTING OF RING-STYLE TEST SPECIMENS FOR THE TENSILE TESTING OF CONDOMS A3.1 Purpose A3.2 General A3.3 Equipment A3.4 Method
8	A4. DETERMINATION OF WIDTH A4.1 Scope A4.2 Principles A4.3 Apparatus A4.4 Procedure A4.5 Report A5. LEAKAGE TEST A5.1 Scope A5.2 Apparatus
9	A5.3 Procedure A5.4 Interpretation of Results A5.5 Report A6. DETERMINATION OF CONDOM THICKNESS A6.1 Scope A6.2 Principles A6.3 Apparatus A6.4 Procedure A6.5 Report A6.6 Condom Disposal
10	A7. AIR BURST TESTING OF POLYURETHANE CONDOMS A7.1 Scope A7.2 Principle A7.3 Apparatus A7.4 Procedure A7.5 Report A8. EXPIRATION DATE TESTING A8.1 A8.2 A8.3 A8.4
11	A8.5 A8.6 A9. CONDOM MATERIAL AND CLINICAL VALIDATION A9.1 Slippage and Breakage User Study A9.2 Shelf Stability Studies A9.3 Permeability X1. TEST METHOD FOR WELD STRENGTH OF POLYURETHANE CONDOMS X1.1 Scope X1.2 Apparatus X1.3 Speed of Testing X1.4 Procedure
12	X1.5 Report X2. CONDOM MATERIALS VALIDATION—STATISTICAL ANALYSIS TO SET SPECIFICATIONS X2.1 Scope X2.2 Distribution of Data X2.3 Example for Normal Distribution of Data X2.4 Long-Term Variability Determination
13	X3. CLINICAL METHODS FOR THE EVALUATION OF A NEW CONDOM SHAPE X3.1 Scope and Objective X3.2 Study Design X3.3 Inclusion Criteria X3.4 Exclusion Criteria X3.5 Informed Consent (recommend following FDA 21 CFR Part 50) X3.6 Adverse Event Report Form X3.7 Statistical Analysis

Additional information

Standard Title	D6324-11 Standard Test Methods for Male Condoms Made from Polyurethane
Published Code	ASTM
Publication Date	2011
Pages Count	13
ICS Codes	83.140.99 - Other rubber and plastics products

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