Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Fourth Revision) which is identical with ISO 7864 : 2016 ‘Sterile hypodermic needles for single use — Requirements and test methods’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on 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 originally published in 1983 and subsequently revised in 1986, 1991 and 2002. First revision was identical with ISO 7864 : 1984. Second revision of this standard was identical with ISO 7864 : 1988. Third revision of this standard was identical with ISO 7864 : 1993. The fourth revision of this standard has been undertaken to align it with the latest version of ISO 7864 : 2016.

The major changes in this revision are as follows:

a) expansion of the range of gauges;

b) introduction of tapered needle designation;

c) reference to the new ISO 80369 series;

d) new informative annex on penetration force;

e) change in Annex B on fragmentation;

f) deleted informative Annex C for symbol for “do-not-reuse” and added normative reference to ISO 15223-1;

g) new informative annex on flow rate;

h) new informative annex on needle bonding strength; and

j) reference to ISO 23908 on sharps injury protection. The text of the ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and 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’.

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.