IS 17751 : Part 2 : 2024/ISO/TR 12417-2 : 2022 Cardiovascular Implants and Extracorporeal Systems - Vascular Device-Drug Combination Products - Part 2 Local Regulatory Information

ICS 11.040.40

MHD 06

NATIONAL FOREWORD

This Indian Standard which (Part 1) (First Revision) is identical to ISO/TR 12417-2 : 2022 'Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Medical and Surgical Cardiology Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2017 and was identical to ISO/TR 12417-2 : 2017 'Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products Part 2: Local regulatory information'. This revision of this standard has been undertaken to align it with the latest version of ISO/TR 12417-2 : 2022.

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'; 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.