{"id":70962,"date":"2024-10-17T14:30:30","date_gmt":"2024-10-17T14:30:30","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/astm-d6324-2011\/"},"modified":"2024-10-24T18:54:08","modified_gmt":"2024-10-24T18:54:08","slug":"astm-d6324-2011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/astm\/astm-d6324-2011\/","title":{"rendered":"ASTM-D6324 2011"},"content":{"rendered":"<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

1.4 The appendixes in these test methods contain information intended to provide guidance.<\/p>\n

1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.<\/p>\n

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.<\/span><\/p>\n

A1.1.1 This annex covers the method for determining the length of polyurethane male condoms.<\/p>\n

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.<\/p>\n

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.<\/p>\n

X1.1.1 This appendix covers the methods for determining the thickness of polyurethane male condoms.<\/p>\n

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.<\/p>\n

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.<\/p>\n

X3.1.1 This appendix covers the test method for determining the strength of welded seams of polyurethane condoms.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nScope
Referenced Documents
Significance and Use <\/td>\n<\/tr>\n
2<\/td>\nMaterials and Manufacture
Requirements
TABLE 1 <\/td>\n<\/tr>\n
3<\/td>\nLabeling
Storage
Condom Material and Clinical Validation <\/td>\n<\/tr>\n
4<\/td>\nA1. DETERMINATION OF LENGTH
A1.1 Scope
A1.2 Principles
A1.3 Apparatus
A1.4 Procedure
A1.5 Report
A1.6 Condom Disposal <\/td>\n<\/tr>\n
5<\/td>\nFIG. A1.1 <\/td>\n<\/tr>\n
6<\/td>\nA2. 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 <\/td>\n<\/tr>\n
7<\/td>\nA3. 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 <\/td>\n<\/tr>\n
8<\/td>\nA4. 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 <\/td>\n<\/tr>\n
9<\/td>\nA5.3 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 <\/td>\n<\/tr>\n
10<\/td>\nA7. 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 <\/td>\n<\/tr>\n
11<\/td>\nA8.5
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 <\/td>\n<\/tr>\n
12<\/td>\nX1.5 Report
X2. CONDOM MATERIALS VALIDATION\u2014STATISTICAL 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 <\/td>\n<\/tr>\n
13<\/td>\nX3. 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 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

D6324-11 Standard Test Methods for Male Condoms Made from Polyurethane<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ASTM<\/b><\/a><\/td>\n2011<\/td>\n13<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":70963,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[1189,2637],"product_tag":[],"class_list":{"0":"post-70962","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-83-140-99","7":"product_cat-astm","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/70962","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/70963"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=70962"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=70962"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=70962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}