Specifies requirements for latex barrier membranes (dams) for prophylactic use including allowable materials, dimensions, surface finish, taste and smell, thermal stability, packaging and labelling as well as physical properties such as elongation and tear and rupture resistance. These differentiate prophylactic dams from other barrier products such as dental dams, which are not intended for, and may not be suitable for use in, sexual situations.
Table of contents
Header
About this publication
Preface
1 Scope
2 Referenced documents
3 Sampling
4 Materials
4.1 Biocompatibility
4.2 Dressing materials
5 Dimensions
5.1 Length and width
5.2 Thickness
6 Surface finish
7 Taste and smell
8 Physical properties
8.1 Freedom from holes
8.2 Tensile properties
8.2.1 Tensile testing
8.2.2 Elongation at break
8.2.3 Tear resistance
8.2.4 Rupture resistance
9 Thermal stability
10 Packaging
11 Labelling
Appendix A
A1 Scope
A2 Statistical sampling
A3 Product certification
A4 Supplier’s quality management system
A5 Other means of assessment
Appendix B
B1 Scope
B2 Principle
B3 Apparatus
B4 Procedure
B5 Report
Appendix C
C1 Scope
C2 Principle
C3 Apparatus
C4 Procedure
C5 Report
Appendix D
D1 Scope
D2 Principle
D3 Apparatus
D4 Procedure
D5 Report
Appendix E
E1 Scope
E2 Principle
E3 Apparatus
E4 Procedure
E5 Report
Appendix F
F1 Scope
F2 Principle
F3 Apparatus
F4 Procedure
F5 Report
Cited references in this standard
Content history
DR 04402
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