EN ISO 10993-4:2017
(Main)Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (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.
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Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2017
1DGRPHãþD
SIST EN ISO 10993-4:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO ,]ELUDSUHVNXVRY]D
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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, which is an integral part
of this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 10993-4:2017 has been approved by CEN as EN ISO 10993-4:2017 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s joint standardization request
M/BC/CEN/89/9 concerning harmonized standards relating to horizontal aspects in the field of medical
devices to provide one voluntary means of conforming to essential requirements of Council Directive
93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) Remarks/Notes
Directive 93/42/EEC of this EN
ER 7.1 (first indent) is partly
covered by ISO 10993-4, since the
standard does not provide
requirements on design and
6.1 and A.1, B.1, C.1, D.1 manufacture. However, this
7.1 (First indent)
and E.1 standard provides a means to
evaluate the interactions of medical
devices with blood. Other forms of
toxicity and flammability are not
dealt with in this standard.
ER 7.1 (second indent) is partly
covered by ISO 10993-4, since the
standard does not provide
requirements on design and
manufacture. However, this
6.1 and A.1, B.1, C.1, D.1 standard provides a means to
7.1 (Second indent)
and E.1 evaluate the interactions of medical
devices with blood. Other forms of
toxicity are not dealt with in this
standard. This evaluation can be a
preliminary step for risk
minimization.
ER 7.2 is partly covered by
ISO 10993-4, since the standard
does not provide requirements on
design, manufacture and packaging.
6.1 and A.1, B.1, C.1, D.1
7.2 However, this standard provides a
and E.1
means to assess the interactions of
medical devices with blood to
contaminants and residues in
medical devices.
ER 7.5 is partly covered by
ISO 10993-4, since the standard
does not provide requirements on
6.1 and A.1, B.1, C.1, D.1 design and manufacture. However,
7.5
and E.1 this standard provides a means to
evaluate interactions of substances
leaking from medical devices with
blood.
General Note: Presumption of conformity depends on also complying with all relevant
clauses/subclauses of ISO 10993-1.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
Annex ZB
(informative)
Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
This European Standard has been prepared under a Commission’s joint standardization request
M/BC/CEN/89/9 concerning harmonized standards relating to horizontal aspects in the field of medical
devices to provide one voluntary means of conforming to essential requirements of 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 [OJ L 189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 90/385/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 4, 5, 8, 9 and 10 of the Directive.
NOTE 3 This Annex ZB is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this
European Standard.
Table ZB.1 — Correspondence between this European Standard and Annex I of Directive
90/385/EEC [OJ L 189]
Essential Requirements of Clause(s)/subclause(s) Remarks/Notes
Directive 90/385/EEC of this EN
ER 9 (first indent) is partly covered
by ISO 10993-4, since the standard
does not provide requirements on
design and manufacture. These
haemocompatibility tests are not
intended to evaluate or determine
the performance of the test sample
6.1 and A.1, B.1, C.1, D.1
9 (first indent)
in terms of mechanical or
and E.1
functional loading. However, this
part of ISO 10993 specifies test
methods for the assessment of the
interaction with blood with
medical devices or biomaterials
intended for use in medical
devices. Other forms of toxicity are
not dealt with in this standard.
ER 9 (second indent) is partly
covered by ISO 10993-4, since the
standard does not provide
requirements on design and
6.1 and A.1, B.1, C.1, D.1 manufacture. However, this
9 (second indent)
and E.1 standard provides a means to
evaluate the interactions of
medical devices with blood. Other
forms of toxicity are not dealt with
in this standard.
General Note: Presumption of conformity depends on also complying with all relevant
clauses/subclauses of ISO 10993-1.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 10993-4
Third edition
2017-04
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
Reference number
ISO 10993-4:2017(E)
©
ISO 2017
ISO 10993-4:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
ISO 10993-4:2017(E)
Contents Page
Foreword .
...
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