ISO10993-42017 Amd12025Biological evaluation of medicaldevices -Part 4Selectio

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Biological evaluation of medical

devices—

Part 4:

Selection of tests for interactions

with blood

AMENDMENT1

Evaluation biologique des dispositifs médicaux—

Partie 4:Choix des essais pour les interactions avec le sang

AMENDEMENT1

Reference number

ISO 10993-4:2017/Amd.1:2025(en)

International

Standard

ISO 10993-4

Third edition

2017-04

AMENDMENT 1

2025-01

◎ISO 2025

ISO10993-4:2017/Amd.1:2025(en)

◎ISO 2025

be reproduced or utlized otherwise in any form or by any means,electronic ormechanical,including photocopying,or postingon

the internet or an intranet,without prior written permision.Permission can be requested from either ISO at the address below

or ISO's member body in the country of the requester.

ISO copyright office

CP401·Ch. de Blandonnet 8

CH-1214 Vernier,Geneva

Phone;+41227490111

Email:copyright⑦iso.org

Website:wwwiso.0Dg

Published inSwitzerland

iii

ISO10993-4:2017/Amd.1:2025(en)

Foreword

ISO (the International Organization for Standardization)is a worldwide federation of national standards

bodies (ISO member bodies).The work of preparing International Standards is normally carried out through

ISO technical committees.Each member body interested in a subject for which a technical committee

has been established has the right to be represented on that committee.International organizations,

governmental and non-governmental,in liaison with ISO,also take part in the work.ISO collaborates closely

with the International Electrotechnical Commission(IEC)onall matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described

in the ISO/IEC Directives,Part 1.In particular,the different approval criteria needed for the different types

of ISO documents should be noted.This document was drafted in accordance with the editorial rules of the

ISO/IEC Directives,Part 2(see www.iso.org/directives ).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a)

patent(s)].ISO takes no position concerning the evidence,validity or applicability of any claimed patent

rights in respect thereof.As of the date of publication of this document,iSO had not received notice of (a)

patent(s)which may be required to implement this document.However,implementers are cautioned that

this may not represent the latest information,which may be obtained from the patent database available at

www.iso.org/patents .ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards,the meaning of ISO specific terms and expressions

related to conformity assessment,as well as information about ISO's adherence to the World Trade

Organization (WTO) principles in the Technical Barriersto Trade(TBT),seewwwiso.org/iso/foreword,html .

This document was prepared by Technical Committee ISO/TC194,Biologicaland clinical evaluationofmedical

devices,in collaboration with the European Committee for Standardization(CEN)Technical Committee CEN/

TC 206, Biological and clinical evaluation ofmedical devices,in accordance with the Agreement on technical

cooperation between ISO and CEN (Vienna Agreement).

A list ofall parts in the ISO 10993 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user's national standards body.A

complete listing of these bodies can be found at www.iso.org/members.html .

3.4

Replace "ISO/TR 10993-20"with "ISO/TS 10993-20"in Note 1 to entry.

5.2.2

Replace the subclause heading with:

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标签： #ISO #10993

摘要：

Biologicalevaluationofmedicaldevices—Part4:SelectionoftestsforinteractionswithbloodAMENDMENT1Evaluationbiologiquedesdispositifsmédicaux—Partie4:ChoixdesessaispourlesinteractionsaveclesangAMENDEMENT1ReferencenumberISO10993-4:2017/Amd.1:2025(en)InternationalStandardISO10993-4Thirdedition2017-04AMENDME...

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