ICS 11.100.20                         MHD 19

NATIONAL FOREWORD

This Indian Standard (Part 4) (First Revision) which is identical with ISO 10993-4 : 2002 ‘Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood’ issued by the International Organization for Standardization (ISO) was adopted by Bureau of Indian Standards on the recommendation of the Immuno-Biological Diagnostic Kits Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 1994 as IS 12572 (Part 14) based on ISO 10993-4: 1992 which has been revised in 2002. This revision is being taken to align it with the latest version of ISO 10993-4.

The selection and design of test methods for the interactions of medical devices with blood should take into consideration device design, materials, clinical utility, usage environment and risk benefit. This level of specificity can only be covered in vertical standards.

The initial source for developing this part of ISO 10993 was the publication, Guidelines for blood/material interactions, Report of the National Heart, Lung, and Blood Institute chapters 9 and 10. This publication has since been revised.

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.