IS 18927 : 2024 Cardiovascular Implants - Transcatheter Cardiac Occluders (ISO 22679 : 2021, MOD)
NATIONAL FOREWORD
This Indian Standard which is identical to ISO 22679 : 2021 'Cardiovascular implants - Transcatheter cardiac occluders' 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 after approval of the Medical Equipment and Hospital Planning Division Council.
This document specifies important In-vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and recommendations for performance tests of the cardiac occluder system. Surgical occluders have been omitted from the scope of this document given their significant differences in device geometry, materials, implantation methods, and test methods as compared to transcatheter cardiac occluders. This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (for example, atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left atrial appendage occluder, and paravalvular leak occluders). This document does not cover noncardiac occluders, but elements of this document can be applicable to patent ductus arteriosus occluders.
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.