EN ISO 10993-4:2002/A1:2006

SLOVENSKI STANDARD
01-oktober-2006
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with
blood - Amendment 1 (ISO 10993-4:2002/Amd 1:2006)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur
Wechselwirkung mit Blut (ISO 10993-4:2002/Amd 1:2006)
Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les
interactions avec le sang - Amendement 1 (ISO 10993-4:2002/Amd 1:2006)
Ta slovenski standard je istoveten z: EN ISO 10993-4:2002/A1:2006
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.

EUROPEAN STANDARD
EN ISO 10993-4:2002/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.100
English Version
Biological evaluation of medical devices - Part 4: Selection of
tests for interactions with blood - Amendment 1 (ISO 10993-
4:2002/Amd 1:2006)
Évaluation biologique des dispositifs médicaux - Partie 4: Biologische Beurteilung von Medizinprodukten - Teil 4:
Choix des essais pour les interactions avec le sang - Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO
Amendement 1 (ISO 10993-4:2002/Amd 1:2006) 10993-4:2002/Amd 1:2006)
This amendment A1 modifies the European Standard EN ISO 10993-4:2002; it was approved by CEN on 7 July 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the Central Secretariat or to any CEN member.
This amendment 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 Central Secretariat has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-4:2002/A1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 10993-4:2002/A1:2006) has been prepared by Technical Committee
ISO/TC 194 "Biological evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 "Biocompatibility of medical and dental materials and devices", the secretariat of
which is held by NEN.
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 January 2007, and conflicting national standards
shall be withdrawn at the latest by January 2007.

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, 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, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 10993-4:2002/Amd 1:2006 has been approved by CEN as EN ISO 10993-
4:2002/A1:2006 without any modifications.

ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC and 90/385/EEC

This European Standard has been prepared under a mandate given to CEN to provide one means
of conforming to Essential Requirements of the New Approach Directives 93/42/EEC Medical
devices: General and 90/385/EEC Medical devices: Active implantable.

Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative clauses of this European Standard confers, within the limits of the scope of this
International Standard, a presumption of conformity with the relevant Essential Requirements of
those Directives and associated EFTA regulations.

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 10993-4
Second edition
2002-10-15
AMENDMENT 1
2006-07-15
Biological evaluation of medical
devices —
Part 4:
Selection of tests for interactions with
blood
AMENDMENT 1
Évaluation biologique des dispositifs médicaux —
Partie 4: Choix des essais pour les interactions avec le sang
AMENDEMENT 1
Reference number
ISO 10993-4:2002/Amd.1:2006(E)
©
ISO 2006
ISO 10993-4:2002/Amd.1:2006(E)
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ISO 10993-4:2002/Amd.1:2006(E)
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) on all
...