IS/ISO 29942 : 2011 : Prophylactic Dams Requirements and Test Methods

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 29942 : 2011 ‘Prophylactic dams - Requirements and test methods’ 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.

A prophylactic dam is used to cover parts of the human body during sexual contact. The prophylactic dam (hereinafter also referred to as “dam”) provides coverage to the external female genitalia or the anal area. Non-porous, intact, polymer films have been demonstrated as barriers to the human immunodeficiency virus (HIV) and other infectious agents responsible for the transmission of sexually transmitted infections (STIs). To be effective, it is essential that dams be free from holes and defects, have adequate physical properties so as not to break during use, be correctly packaged to protect them during storage and be correctly labelled to facilitate their use.

To be safe, it is essential that the dam and additive, dressing, individual packaging material or powder applied to it neither contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating or otherwise harmful under normal conditions of storage or use.

Prophylactic dams are non-sterile medical devices; however, a clean environment is essential to minimize microbiological and particulate contamination of the product during manufacturing and packaging. To ensure a high-quality product, it is essential that it be designed and produced under a good quality management system.

It is intended that manufacturers conduct stability tests to estimate the shelf-life of any new or modified design before the product is placed on the market. These tests are intended to ensure that manufacturers have adequate data to support shelf-life claims before products are placed on the market and that these data are available for review by regulatory authorities, test laboratories and purchasers. They are also intended to limit the need for third parties to conduct long-term stability studies. Real-time shelf-life studies are also initiated, but not necessarily completed, prior to placing the product on the market.

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