EN ISO 22442-3:2007

SLOVENSKI STANDARD
01-april-2008
1DGRPHãþD
SIST EN 12442-3:2001
0HGLFLQVNLSULSRPRþNLNLXSRUDEOMDMRåLYDOVNDWNLYDLQQMLKRYHGHULYDWHGHO
9DOLGDFLMDSULL]ORþLWYLLQDOLLQDNWLYDFLMLYLUXVRYLQDJHQVRYWUDQVPLVLYQLK
VSRQJLIRUPQLKHQFHIDORSDWLM76(,62
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the
elimination and/or inactivation of viruses and transmissible spongiform encephalopathy
(TSE) agents (ISO 22442-3:2007)
Tierische Gewebe und deren Derivate nutzende Medizinprodukte - Teil 3: Validierung
der Abreicherung und/oder Inaktivierung von Viren und Erregern der übertragbaren
spongiösen Enzephalopathie (TSE) (ISO 22442-3:2007)
Tissus animaux et leurs dérivés utilisés dan la fabrication des dispositifs médicaux -
Partie 3: Validation de l'élimination et/ou de l'inactivation des virus et autres agents
responsables d'encéphalopathie spongiforme transmissible (EST) (ISO 22442-3:2007)
Ta slovenski standard je istoveten z: EN ISO 22442-3:2007
ICS:
11.120.01
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 22442-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2007
ICS 11.100.20 Supersedes EN 12442-3:2000
English Version
Medical devices utilizing animal tissues and their derivatives -
Part 3: Validation of the elimination and/or inactivation of viruses
and transmissible spongiform encephalopathy (TSE) agents
(ISO 22442-3:2007)
Dispositifs médicaux utilisant des tissus animaux et leurs Tierische Gewebe und deren Derivate, die zur Herstellung
dérivés - Partie 3: Validation de l'élimination et/ou de von Medizinprodukten eingesetzt werden - Teil 3:
l'inactivation des virus et autres agents responsables Validierung der Eliminierung und/oder Inaktivierung von
d'encéphalopathie spongiforme transmissible (EST) (ISO Viren und Erregern der übertragbaren spongiösen
22442-3:2007) Enzephalopathie (TSE) (ISO 22442-3:2007)
This European Standard was approved by CEN on 14 December 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22442-3:2007: E
worldwide for CEN national Members.

Contents Page
Foreword.3

Foreword
This document (EN ISO 22442-3:2007) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration with Technical Committee CEN/TC 316 “Medical devices
utilizing tissues” the secretariat of which is held by NBN.
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 June 2008, and conflicting national standards shall be withdrawn at
the latest by June 2008.
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 12442-3:2000.
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 EC Directive(s).
This European Standard has been developed for medical devices regulated by the Medical Device Directive
93/42/EC as amended by 2003/32/EC (see Annex ZA). By analogy, it could be applied for active implantable
medical devices regulated by the Active Implantable Medical Device Directive 90/385/EC.
For relationship with EC 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, 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 22442-3:2007 has been approved by CEN as a EN ISO 22442-3:2007 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC as amended by Commission Directive 2003/32/EC

This European 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, concerning medical devices, as amended by Commission Directive
2003/32/EC in relation to detailed specifications regarding requirements for medical devices utilizing tissues of
animal origin.
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 clauses of this
standard given in table ZA 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 ZA — Correspondence between this European Standard and Directive 93/42/EEC as amended by
Commission Directive 2003/32/EC
Clause(s)/subclause(s) of this Essential requirements (ERs) of Qualifying remarks/Notes
International Standard Directive 93/42/EEC as amended
by Commission Directive
2003/32/EC
4, 5, 6, 7, 8, 9, Annex A Annex I, 7.1, 7.2, 8.1, 8.2
4, 5, 6, 7, 8, 9, Annex A Annex of Commission Directive
2003/32/EC
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 22442-3
First edition
2007-12-15
Medical devices utilizing animal tissues
and their derivatives —
Part 3:
Validation of the elimination and/or
inactivation of viruses and transmissible
spongiform encephalopathy (TSE) agents
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés —
Partie 3: Validation de l'élimination et/ou de l'inactivation des virus et
autres agents responsables d'encéphalopathie spongiforme
transmissible (EST)
Reference number
ISO 22442-3:2007(E)
©
ISO 2007
ISO 22442-3:2007(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2007
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2007 – All rights reserved

ISO 22442-3:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements. 3
4.1 Risk management . 3
4.2 Sourcing and manufacturing process. 3
4.3 General requirements related to validation . 3
5 Literature review . 4
5.1 Conduct of the literature review. 4
5.2 Application of literature review output. 4
5.3 Viruses . 4
5.4 TSE agents . 4
6 Elimination and/or inactivation study of viruses and TSE agents . 5
6.1 General. 5
6.2 Protocol . 5
6.3 Conduct of the study. 6
6.4 Interpretation of data. 6
7 Final report . 6
8 Review of final report . 6
9 Routine monitoring and control of critical process parameters . 6
Annex A (normative) Requirements related to literature review. 7
Annex B (informative) Guidance on the elimination and/or inactivation study for viruses . 11
Annex C (informative) Guidance on the elimination and/or inactivation study for TSE agents . 16
Annex D (informative) Guidance on scaling down . 17
Annex E (informative) Statistical evaluation of virus titres and reduction factors and assessment
of their validity . 18
Annex F (informative) Calculation of reduction factors . 19
Annex G (informative) Probability of detection of agents at low concentrations. 20
Bibliography . 21

ISO 22442-3:2007(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 Electrotechni
...