EN ISO 10993-4:2017

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood.
It describes
a)    a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1,
b)    the fundamental principles governing the evaluation of the interaction of devices with blood,
c)    the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.

Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO 10993-4:2017)

Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les interactions avec le sang (ISO 10993-4:2017)

ISO 10993-4:2017 spécifie des exigences générales pour l'évaluation des interactions des dispositifs médicaux avec le sang.
Il décrit les éléments suivants:
a)    une classification des dispositifs médicaux destinés à être en contact avec le sang lors de leur utilisation, classification fondée sur l'utilisation prévue et la durée du contact définies dans l'ISO 10993‑1;
b)    les principes fondamentaux qui gouvernent l'évaluation de l'interaction des dispositifs avec le sang;
c)    la justification du choix des essais retenus selon les catégories, ainsi que les principes et la base scientifique de ces essais.
Les exigences détaillées pour les essais ne peuvent pas être spécifiées en raison de limites de connaissance et de précision des essais relatifs à l'évaluation des interactions des dispositifs avec le sang. Le présent document décrit l'évaluation biologique en termes généraux et il se peut qu'il ne fournisse pas nécessairement des préconisations suffisantes concernant les méthodes d'essai relatives à un dispositif spécifique.
Les modifications apportées au présent document ne signifient pas que les essais réalisés selon les versions précédentes sont invalides. Pour les dispositifs commercialisés dont l'utilisation clinique sûre est établie, il n'est pas recommandé de réaliser des essais supplémentaires selon la présente révision.

Biološko ovrednotenje medicinskih pripomočkov - 4. del: Izbira preskusov za ugotavljanje interakcij s krvjo (ISO 10993-4:2017)

Ta dokument določa splošne zahteve za ovrednotenje interakcij medicinskih pripomočkov s krvjo.
Opisuje:
a) razvrstitev medicinskih pripomočkov, namenjenih za uporabo v stiku s krvjo, na podlagi predvidene uporabe in trajanja stika, kot je opredeljeno v standardu ISO 10993-1;
b) temeljna načela za ovrednotenje interakcije pripomočkov s krvjo;
c) utemeljitev strukturirane izbire preskusov v skladu s posebnimi kategorijami skupaj z načeli in znanstveno osnovo teh preskusov.
Podrobnih zahtev za preskušanje ni mogoče določiti zaradi omejitev pri poznavanju in natančnosti preskusov za ovrednotenje interakcij pripomočkov s krvjo. Ta dokument opisuje biološko ovrednotenje s splošnimi izrazi in morda ne podaja zadostnih smernic za preskusne metode za določen pripomoček.
Spremembe v tem dokumentu ne pomenijo, da so preskusi, opravljeni v skladu s prejšnjimi različicami tega dokumenta, neveljavni. Za tržene pripomočke z zgodovino varne klinične uporabe dodatno preskušanje v skladu s to revizijo ni priporočeno.

General Information

• Status: Published
• Publication Date: 17-Oct-2017
• Withdrawal Date: 29-Apr-2018
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Oct-2017
• Completion Date: 18-Oct-2017
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 10993-4:2017 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

Relations

• Replaces: EN ISO 10993-4:2009 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 10993-4:2017 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
• Effective Date: 25-Oct-2017
• Replaced By: EN ISO 10993-4:2017 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
• Effective Date: 25-Oct-2017
• Amended By: EN ISO 10993-4:2017/prA1 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
• Effective Date: 26-Apr-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-4:2017
01-september-2017
1DGRPHãþD
SIST EN ISO 10993-4:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO,]ELUDSUHVNXVRY]D
XJRWDYOMDQMHLQWHUDNFLMVNUYMR,62
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with
blood (ISO 10993-4:2017)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur
Wechselwirkung mit Blut (ISO 10993-4:2017)
Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les
interactions avec le sang (ISO 10993-4:2017)
Ta slovenski standard je istoveten z: EN ISO 10993-4:2017
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-4:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-4:2017

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SIST EN ISO 10993-4:2017


EN ISO 10993-4
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2017
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-4:2009
English Version

Biological evaluation of medical devices - Part 4: Selection
of tests for interactions with blood (ISO 10993-4:2017)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 4:
4: Choix des essais pour les interactions avec le sang Auswahl von Prüfungen zur Wechselwirkung mit Blut
(ISO 10993-4:2017) (ISO 10993-4:2017)
This European Standard was approved by CEN on 23 February 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-4:2017 E
worldwide for CEN national Members.

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SIST EN ISO 10993-4:2017
EN ISO 10993-4:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 4
Annex ZB (informative)  Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 6

2

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SIST EN ISO 10993-4:2017
EN ISO 10993-4:2017 (E)
European foreword
This document (EN ISO 10993-4:2017) has been prepared by Technical Committee ISO/TC 194
“Biological and clinical evaluation of medical devices” in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” the secretariat of which is held by
DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2017, and conflicting national standards
shall be withdrawn at the latest by November 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 10993-4:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA and Annex ZB, whic
...

SLOVENSKI STANDARD
oSIST prEN ISO 10993-4:2016
01-februar-2016
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO,]ELUDSUHVNXVRY]D
XJRWDYOMDQMHLQWHUDNFLMVNUYMR,62',6
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with
blood (ISO/DIS 10993-4:2015)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur
Wechselwirkung mit Blut (ISO 10993-4:2002, einschließlich ¿nderung 1:2006)
Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les
interactions avec le sang (ISO/DIS 10993-4:2015)
Ta slovenski standard je istoveten z: prEN ISO 10993-4
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
oSIST prEN ISO 10993-4:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 10993-4:2016

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oSIST prEN ISO 10993-4:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10993-4
ISO/TC 194 Secretariat: DIN
Voting begins on: Voting terminates on:
2015-11-26 2016-02-26
Biological evaluation of medical devices —
Part 4:
Selection of tests for interactions with blood
Évaluation biologique des dispositifs médicaux —
Partie 4: Choix des essais pour les interactions avec le sang
ICS: 11.100.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10993-4:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

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oSIST prEN ISO 10993-4:2016
ISO/DIS 10993-4:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2015 – All rights reserved

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oSIST prEN ISO 10993-4:2016
ISO/DIS 10993-4
Contents Page
Foreword . vi
Introduction . viii
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Abbreviated terms .4
5 Types of devices in contact with blood (as categorized in ISO 10993-1:2009) .5
5.1 Non-blood-contact devices .
...