Reaffirmed 2019

NATIONAL FOREWORD

This Indian Standard (Part 4) (First Revision) which is identical with ISO 10555-4 : 2013‘Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standards was first published in 2009 by adopting ISO 10555-4 : 1996. The first revision of this standard has been brought out to align it with the latest version of ISO 10555-4 : 2013.

Intravascular balloon dilatation catheter fitted with a balloon near the distal end, which is introduced into an artery or vein to dilate a part or parts of the vascular system.

This standard is one of the standard on ‘Intravascular catheters - Sterile and single-use catheters’. Other parts in this series are:

Part 1 General requirements

Part 3 Central venous catheters

Part 5 Over-needle peripheral catheters

NOTE - Part 2 of this standard has been withdrawn and its contents has now been included in IS/ISO 10555-1 : 2013 ‘Intravascular catheters -Sterile and single-use catheters : Part 1 General requirements (first revision)’.

This standard also makes a reference to the BIS Certification Marking of the product. Details of which are given in National Annex A.

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.