ICS 11.100                          MHD 19

NATIONAL FOREWORD

This Indian Standard (Part 17) which is identical with ISO 10993-17 : 2002 ‘Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Immuno-Biological Diagnostic Kits Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard has been published in 19 parts. The other parts of this standard are given below:

Part 1 Evaluation and testing within a risk management process

Part 2 Animal welfare requirements

Part 3 Tests for genotoxicity, carcinogenicity and reproductive toxicity

Part 4 Selection of tests for interactions with blood

Part 5 Tests for in vitro cytotoxicity

Part 6 Tests for local effects after implantation

Part 7 Ethylene oxide sterilization residuals

Part 9 Framework for identification and quantification of potential degradation products

Part 10 Tests for irritation and skin sensitization

Part 11 Tests for systemic toxicity

Part 12 Sample preparation and reference materials

Part 13 Identification and quantification of degradation products from polymeric medical devices

Part 14 Identification and quantification of degradation products from ceramics

Part 15 Identification and quantification of degradation products from metals and alloys

Part 16 Toxicokinetic study design for degradation products and leachables

Part 18 Chemical characterization of materials

Part 19 Physico-chemical, morphological and topographical characterization of materials

Part 20 Principles and methods for immunotoxicology testing of medical devices

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