National foreword

This British Standard is the UK implementation of

ENISO 10993-11:2018. Itis identical to ISO 10993-11:2017. Itsupersedes BS EN ISO 10993 11:2009, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

© The British Standards Institution 2018

Published by BSI Standards Limited 2018

ISBN 978 0 580 91734 9

ICS 11.100.20

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2018.