NATIONAL FOREWORD

This Indian Standard (Part 2) which is identical with ISO 3826-2 : 2008 ‘Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets’ 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 standard was earlier published as IS 15102 : 2002 by adopting ISO 3832 : 1993 identically under dual number. On revision of ISO 3826 in three parts, the committee also decided to adopt this standard in three parts under a single number series as IS/ISO to make pace with the latest international practice. On publication, these three parts supersede IS 15102 : 2002 ‘Plastics collapsible containers for human blood and blood components’.

This standard is published in three parts. Other two parts in this series are:

Part 1 Conventional containers

Part 3 Blood bag systems with integrated features

This standard has been prepared to:

— Reduce the need for multiple translations of words into national languages.

— Simplify and rationalize the labelling of blood treatment and transfusion devices which are medical devices used in critical situations, thereby reducing risk of misidentification, promoting safety for the patient and reducing the amount of training required by healthcare personnel.

— Promote the movement of blood treatment and transfusion devices across national boundaries.

— Support the essential requirements of relevant EU Directives.

The meaning of many of these graphical symbols should be self-evident. The meaning of others will become clear with use or when viewed in the context of the device itself. If appropriate, the meaning of symbols should be explained in accompanying literature when provided. Annex A provides examples of how the symbols specified in this standard can be used. These are illustrative only and do not represent the only ways in which requirements of this standard can be met.

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.