Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 16) which is identical with ISO 10993-16 : 2017 ‘Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Biological and Clinical Evaluation of Medical Devices and Immuno-Biological Diagnostic Kits Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard is published in various parts. The other parts of the 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 17 Establishment of allowable limits for leachable substances

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

Part 22 Guidance on nanomaterials

Part 33 Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

The text of 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.