IS/ISO 13402 : 1995 : Surgical And Dental Hand Instruments - Determination of Resistance Against Autoclaving, Corrosion and Thermal Exposure

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 13402 : 1995 —Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Surgical Instruments Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

The procedures described in this standard are indented to form a harmonized series of tests that may be referred to, individually or in combination, in other separate product standards. The requirements for such tests shall be defined and stated within the body of the product standard along with the number of cycles for each test procedure.

The tests apply to dental and surgical instruments and are already standardized in relevant product standard [for example, IS 3642 (Part 1) : 1990 —Surgical instruments: Part 1 Non-cutting articulated instruments’]. However, the test procedures as stated in the product standards differ in minor details. An alignment and a compilation was established. The most important test methods for dental and surgical instruments have been brought together in one general Indian Standard.

This standard does not specify any test sequence nor any requirements related to specific instruments. The requirements, the test sequence and the number of test cycles have to be defined in the relevant product standards or, if no standard is available, it has to be left to the decision of the purchaser and/or the manufacturer.

Apart from the boiling water test, the autoclave test applies for determining corrosion resistance. In this sense, this standard specifies two test methods for determining corrosion resistance. When placing an order, it is intended that the purchaser state whether both tests are to be carried out or which of the two tests. If the purchaser does not so indicate, the choice is left to the discretion of the manufacturer.

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.