NATIONAL FOREWORD

This Indian Standard which is identical with ISO 7405 : 2008 ‘Dentistry — Evaluation of biocompatibility of medical devices used in dentistry’ issued by the International Organization for Standardization (ISO) was adopted by the 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 as IS 12572 (Part 10) : 1988 ‘Guide for evaluation of medical devices for biological hazards: Part 10 Medhods of biological testing and evaluation of dental materials by taking assistance from BS 5828 : 1980 Medhods of biological assessment of dental materials’, issed by the British Standards Institution, UK. Subsequent to the revision and withdrawal of BS 5828 : 1980 by ISO 7405 : 2018 ‘Dentistry — Evaluation of biocompatibility of medical devices used in dentistry’, the committee has decided to adopt ISO 7405 : 2008. Hence after the publication of this standard IS 12572 (Part 10) : 1988 shall be treated as withdrawn.

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.