EN ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

ISO 10993-1:2009 describes:
the general principles governing the biological evaluation of medical devices within a risk management process;
the general categorization of devices based on the nature and duration of their contact with the body;
the evaluation of existing relevant data from all sources;
the identification of gaps in the available data set on the basis of a risk analysis;
the identification of additional data sets necessary to analyse the biological safety of the medical device;
the assessment of the biological safety of the medical device.

Biologische Beurteilung von Medizinprodukten Teil 1: Beurteilung und Prüfung (ISO 10993-1:2003)

Dieser Teil von ISO 10993 beschreibt
a) die allgemeinen Grundsätze, die für die biologische Beurteilung von Medizinprodukten gelten,
b) die Einteilung von Medizinprodukten basierend auf Applikationsort und Kontaktdauer mit dem
menschlichen Körper,
c) die Auswahl geeigneter Prüfverfahren.
Dieser Teil von ISO 10993 gilt nicht für Prüfungen von Materialien und Produkten, die weder direkt oder
indirekt mit dem Körper des Patienten in Kontakt kommen. Diese Norm beschreibt auch nicht biologische
Gefährdungen, die durch mechanisches Versagen hervorgerufen werden.
ANMERKUNG Andere Teile der Reihe ISO 10993 [1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18] decken spezifische
Prüfungen ab (siehe auch die Begründung in A.2).

Évaluation biologique des dispositifs médicaux - Partie 1: Evaluation et essais (ISO 10993-1:2003)

L'ISO 10993-1:2009 décrit
les principes généraux sur lesquels repose l'évaluation biologique des dispositifs médicaux dans un processus de gestion des risques,
la classification générale des dispositifs, fondée sur la nature et la durée de leur contact avec le corps humain,
l'évaluation de toutes les données existantes,
l'identification de manques dans les ensembles de données disponibles sur la base d'une analyse de risque,
l'identification d'ensembles de données supplémentaires nécessaires à l'analyse de la sécurité biologique du dispositif médical et l'évaluation de la sécurité biologique du dispositif médical.

Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja (ISO 10993-1:2009)

Ta del standarda ISO 10993 opisuje: - splošna načela, ki veljajo za biološko ovrednotenje medicinskih pripomočkov znotraj procesa obvladovanja tveganja; - splošno razvrščanje pripomočkov na osnovi narave in trajanja njihovega stika s telesom; - ovrednotenje obstoječih ustreznih podatkov iz vseh virov; - identifikacijo vrzeli v razpoložljivem podatkovnem nizu na osnovi analize tveganja; - identifikacijo dodatnih podatkovnih nizov, potrebnih za analizo biološke varnosti medicinskega pripomočka; - ocenjevanje biološke varnosti medicinskega pripomočka. Ta del standarda ISO 10993 ne zajema preskušanja materialov in pripomočkov, ki ne prihajajo v neposreden ali posreden stik z bolnikovim telesom, ter ne zajema bioloških nevarnosti, ki izhajajo iz kakršne koli mehanske okvare. Drugi deli standarda ISO 10993 zajemajo posebne preskuse, navedene v Predgovoru.

General Information

• Status: Withdrawn
• Publication Date: 09-Jun-2009
• Withdrawal Date: 14-Oct-2009
• 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
• Start Date: 15-Oct-2009
• Completion Date: 15-Oct-2009
• 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 10993-1:2010 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Relations

• Replaces: EN ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 10993-1:2020 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
• Effective Date: 23-Dec-2020
• Corrected By: EN ISO 10993-1:2009/AC:2010 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2010
1DGRPHãþD
SIST EN ISO 10993-1:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2FHQDLQSUHVNXãDQMH
]QRWUDMSURFHVDREYODGRYDQMDWYHJDQMD,62
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process (ISO 10993-1:2009)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im
Rahmen eines Risikomanagementsystems (ISO 10993-1:2009)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein
d'un processus de gestion du risque (ISO 10993-1:2009)
Ta slovenski standard je istoveten z: EN ISO 10993-1:2009
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 10993-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2009
ICS 11.100.20 Supersedes EN ISO 10993-1:2009, June
English Version
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (ISO 10993-1:2009)
Évaluation biologique des dispositifs médicaux - Partie 1: Biologische Beurteilung von Medizinprodukten - Teil 1:
Évaluation et essais au sein d'un processus de gestion du Beurteilung und Prüfungen im Rahmen eines
risque (ISO 10993-1:2009) Risikomanagementsystems (ISO 10993-1:2009)
This European Standard was approved by CEN on 17 September 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 10993-1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices .4
Annex ZB (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5

Foreword
This document (EN ISO 10993-1:2009) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration with 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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 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 10993-1:2009, June.
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 Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts 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, 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 the United Kingdom.
Endorsement notice
The text of ISO 10993-1:2009 has been approved by CEN as a EN ISO 10993-1:2009 without any
modification.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical devices.
Once this International Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as a national standard in at least one Member State, compliance with the clauses of
this International Standard given in Table ZA.1 confers, within the limits of the scope of this Intenational
Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC on
Medical devices
Essential Requirements (ERs) of
Clause(s)/subclause(s) of this Qualifying remarks/notes
Directive 93/42/EEC on Medical
International Standard
devices
4, 5, 6, 7 Annex I:
7.1, 7.2 and 7.5
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this International Standard.
Annex ZB
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on Active Implantable Medical Devices.
Once this International Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as a national standard in at least one Member State, compliance with the clauses of
this International Standard given in Table ZB.1 confers, within the limits of the scope of this International
Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on Active
Implantable Medical Devices
Essential Requirements (ERs) of
Clause(s)/subclause(s) of this Qualifying remarks/notes
Directive 90/385/EEC on Active
International Standard
Implantable Medical Devices
4, 5, 6, 7 Annex I:
Indents 1 and 2 of Clause 9 only

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

INTERNATIONAL ISO
STANDARD 10993-1
Fourth edition
2009-10-15
Biological evaluation of medical
devices —
Part 1:
Evaluation and testing within a risk
management process
Évaluation biologique des dispositifs médicaux —
Partie 1: Évaluation et essais au sein d'un processus de gestion
du risque
Reference number
ISO 10993-1:2009(E)
©
ISO 2009
ISO 10993-1:2009(E)
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ISO 10993-1:2009(E)
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General principles applying to biological evaluation of medical devices.3
5 Categorization of medical devices .6
5.1 General .6
5.2 Categorization by nature of body contact .6
5.3 Categorization by duration of contact.7
6 Biological evaluation process.8
6.1 Material characterization .8
6.2 Biological evaluation tests .8
7 Interpretation of biological evaluation data and overall biological safety assessment .14
Annex A (informative) Biological evaluation tests .15
Annex B (informative) Guidance on the risk management process.16
Annex C (informative) Suggested procedure for literature review .19
Bibliography.21

ISO 10993-1:2009(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 matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This fourth edition cancels
...