IS 17932 : Part 6 : 2023 Biological Evaluation of Medical Devices - Part 6 Tests for Skin Sensitization (ISO 10993-10 : 2021, MOD)

ICS 11.100.20

MHD 19

(Superseding IS/ISO 10993-10 : 2010)

NATIONAL FOREWORD

This Indian Standard (Part 6) which is a modified adoption of ISO 10993-10 : 2021 'Biological evaluation of medical devices - Part 10: Tests for skin sensitization' issued by the International Organization for Standardization was adopted by Bureau of Indian Standards on the recommendation of Biological Evaluation of Medical Devices and In-vitro Diagnostic Medical Devices Sectional Committee and after approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published as IS/ISO 10993-10 : 2010 'Biological evaluation of medical devices: Part 10 Tests for irritation and skin sensitization'. This supersession has been undertaken to align it with the latest edition of ISO 10993-10 : 2021.

The text of ISO standard may be approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the 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'; and

 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.