This Standard specifies requirements for condoms, made from compounded natural rubber latex, supplied in consumer packages, designed to be worn over the erect penis during sexual intercourse to prevent semen from entering the vagina and to assist in the prevention of sexually transmitted diseases.
NOTE-
(1) The efficacy of spermicidal and other active lubricants or dressing materials is not within the scope of this Standard. The condom and any lubricant, dressing material or powder applied to it should neither contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating or otherwise harmful under normal conditions of use. A manufacturer may be required by a certification or inspection authority or by a purchaser to provide a certificate of composition and/or other properties.
(2) Condoms are mass-produced articles. Inevitably there will be some variation between individual condoms, and a small proportion of condoms in each production run may contain defects. Information regarding the verification of quality of condoms and sampling plans that shall be used in cases of dispute and to assess compliance with the Standard of a batch of condoms are given in Appendix A.
(3) Guidance on the determination of properties of condoms that have been stored after purchase is given in Appendix B.
(4) Recommendations on the storage of packaged condoms are given in Appendix C, which does not form a normative part of this Part.