NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 7439 : 2015 ‘Copper-bearing contraceptive intrauterine devices - Requirements and tests’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Obstetrics and Gynaecological Instruments and Appliances Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published as IS/ISO 7439 : 2002 ‘Copper-bearing intra-uterine contraceptive devices - Requirements, tests’. The first revision of this standard has been undertaken to align it with the latest version of ISO 7439 : 2015.

Although every foreign object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearing contraceptive intrauterine devices (IUDs) function is by the continuous release of copper ions. This interferes with some enzymatic functions, immobilizes sperm cells and inhibits fertilization. These contribute to the high effectiveness of the contraception. The effectiveness of copper-bearing IUDs is many times greater than that of a simple plastics body.

This standard also makes a reference to the BIS Certification Marking of the product. Details of which are given in National Annex A.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions 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.