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)

ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
a classification of medical and dental 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,
the fundamental principles governing the evaluation of the interaction of devices with blood,
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 interactions of devices with blood. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO 10993-4:2002, einschließlich Änderung 1:2006)

Dieser Teil von ISO 10993 legt allgemeine Anforderungen zur Beurteilung der Wechselwirkungen von
Medizinprodukten mit Blut fest.
Dieser Teil enthält:
a) eine Klassifizierung von für den Kontakt mit Blut vorgesehenen medizinischen und zahnmedizinischen
Produkten, die nach der Festlegung in ISO 10993-1 auf der bestimmungsgemäßen Verwendung und
Dauer des Kontakts beruht;
b) die Grundprinzipien, die für die Beurteilung der Wechselwirkungen von Medizinprodukten mit Blut maßgebend
sind;
c) die Begründung für die strukturierte Auswahl von Prüfungen nach bestimmten Kategorien, zusammen mit
den Prinzipien und der wissenschaftlichen Grundlage dieser Prüfungen.
Einzelheiten von Prüfanforderungen können wegen des eingeschränkten Wissensstandes und der
mangelnden Präzision von Prüfungen auf Wechselwirkungen von Medizinprodukten mit Blut nicht festgelegt
werden. Außerdem beschreibt dieser Teil von ISO 10993 die biologische Beurteilung im allgemeinen Sinne
und braucht nicht unbedingt eine ausreichende Anleitung für Prüfverfahren für ein bestimmtes Medizinprodukt
zu sein. Die Auswahl und das Design des Prüfverfahrens sollten das Produktdesign, die Werkstoffe, den
klinische Nutzen, die Verwendungsumgebung und die Risikoabschätzung in Betracht ziehen. Diese
spezifische Ebene kann nur durch vertikale Normen abgedeckt werden.

Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les interactions avec le sang (ISO 10993-4:2002, Amd 1:2006 inclus)

L'ISO 10993-4:2002 fournit des exigences générales pour évaluer les interactions des dispositifs médicaux avec le sang.
Elle décrit
une classification des dispositifs médicaux et dentaires destinés à être en contact avec le sang lors de leur utilisation; cette classification est fondée sur l'utilisation prévue et sur la durée du contact telle qu'elle est définie dans l'ISO 10993-1;
les principes fondamentaux qui gouvernent l'évaluation de l'interaction des dispositifs avec le sang;
la justification du choix des essais retenus conformément aux catégories spécifiques, ainsi que les principes et les bases scientifiques 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 aux interactions des dispositifs avec le sang. L'ISO 10993-4:2002 décrit l'évaluation biologique en termes généraux et il se peut qu'elle ne fournisse pas nécessairement une aide suffisante concernant les méthodes d'essai relatives à un dispositif spécifique.

Biološko ovrednotenje medicinskih pripomočkov - 4. del: Izbira preskusov za ugotavljanje interakcij s krvjo (ISO 10993-4:2002, vključno z Amd 1:2006)

General Information

• Status: Withdrawn
• Publication Date: 19-May-2009
• Withdrawal Date: 09-May-2017
• ICS: 11.100 - Laboratory medicine
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 10-May-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/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 10993-4:2009 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

Relations

• Replaces: EN ISO 10993-4:2002/A1:2006 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2002/Amd 1:2006)
• Effective Date: 30-May-2009
• Replaces: EN ISO 10993-4:2002 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)
• Effective Date: 30-May-2009
• 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: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-4:2009
01-september-2009
1DGRPHãþD
SIST EN ISO 10993-4:2003
SIST EN ISO 10993-4:2003/A1:2006
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO,]ELUDSUHVNXVRY]D
XJRWDYOMDQMHLQWHUDNFLMVNUYMR,62YNOMXþQR]$PG
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with
blood (ISO 10993-4:2002, including Amd 1:2006)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur
Wechselwirkung mit Blut (ISO 10993-4:2002, einschließlich Änderung 1:2006)
Évaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais concernant
les interactions avec le sang (ISO 10993-4:2002, Amd 1:2006 inclus)
Ta slovenski standard je istoveten z: EN ISO 10993-4:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-4:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-4:2009

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SIST EN ISO 10993-4:2009
EUROPEAN STANDARD
EN ISO 10993-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.100.20 Supersedes EN ISO 10993-4:2002
English Version
Biological evaluation of medical devices - Part 4: Selection of
tests for interactions with blood (ISO 10993-4:2002, including
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 (ISO Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO
10993-4:2002, Amd 1:2006 inclus) 10993-4:2002, einschließlich Änderung 1:2006)
This European Standard was approved by CEN on 28 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-4:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10993-4:2009
EN ISO 10993-4:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5

2

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SIST EN ISO 10993-4:2009
EN ISO 10993-4:2009 (E)
Foreword
The text of ISO 10993-4:2002, including Amd 1:2006 has been prepared by Technical Committee
ISO/TC 194 “Biological evaluation of medical devices” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 10993-4:2009 by Technical Committee CEN/TC 206 “Biological
evaluation of medical 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 10993-4:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports
...