Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 8009 : 2014 ‘Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests’ 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 originally published in 2004 identical with ISO 8009. The first revision of this standard has been undertaken to align it with the latest version of IS 8009 : 2014.

Diaphragms are medical devices, therefore, they should be produced under a good quality management system. Reference should be made, for example, to IS/ISO 9000 series, in conjunction with IS/ISO 13485.

The sampling plans and acceptance quality limits (AQLs) given in this standard are for referee testing. The AQLs represent the maximum tolerable level of defects in the products. As diaphragms are intended for re-use, manufacturers should strive for entirely defect-free product.

Manufacturers can devise and apply additional and alternative quality control measures for their use and after production. These methods can differ among manufacturers

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 isparticularly 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.