IS/ISO 23409 : 2011 : Male Condoms - Requirements and Test Methods for Condoms Made from Synthetic Materials

Reaffirmed 2020

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 23409 : 2011 ‘Male condoms - Requirements and test methods for condoms made from synthetic materials’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Obstetric and Gynaecological Instruments and Appliances Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

Synthetic condoms can be made from 100% synthetic materials or a blend of synthetic materials and natural rubber latex. The material(s) used in synthetic condoms should be validated as constituting a barrier to human immunodeficiency virus (HIV), to other infectious agents responsible for the transmission of sexually transmitted infections (STIs), and to spermatozoa. It is essential that the condoms fit the penis properly, remain on the penis during use, are free from holes and have adequate physical strength so as not to break or tear during use so that the condoms can be deemed to be effective for contraceptive purposes and in order to help prevent the transmission of STIs. It is also important that they be correctly packaged so that they are protected during storage and suitably labelled. All of these issues are addressed in this standard.

To be safe, It is essential that the condom and any lubricant, additive, marking materials, dressing, individual packaging material or powder applied to it neither contain nor liberate substances in amounts that are toxic, likely to produce allergies (sensitization), locally irritating or otherwise harmful under normal conditions of storage and use.

Condoms are medical devices. To ensure high quality product, it is essential that condoms be produced under a quality management system using design controls. Condoms are non-sterile medical devices, however, a clean environment is essential to minimize microbiological contamination of the product during manufacturing and packaging.

Condoms can be of the designs given in the following terms, which are not intended to be exhaustive: smooth, textured, parallel-sided, non-parallel-sided, plain-ended, reservoir-ended, dry, lubricated, transparent, translucent, opaque, coloured, preshaped, welded or non-welded.

This standard specifies preclinical, clinical, and lot-by-lot physical requirement testing for condoms made form synthetic materials, including condoms made from a blend of synthetic materials and natural rubber latex. Application of lot-by-lot testing requirements becomes relevant only after the preclinical and clinical requirements of this standard have been met.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions and terminologies are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.