EN ISO 22442-1:2007
(Main)Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
ISO 22442-1:2007 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. ISO 22442-1:2007 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
contamination by bacteria, moulds or yeasts;
contamination by viruses;
contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
material responsible for undesired pyrogenic, immunological or toxicological reactions.
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2007)
Dieser Teil von ISO 22442 bezieht sich auf Medizinprodukte, mit Ausnahme von in-vitro-Diagnostika, herge¬stellt unter Verwendung von Materialien tierischen Ursprungs, die nicht lebensfähig sind oder abgetötet wurden. Er ergibt in Verbindung mit ISO 14971 ein Verfahren zur Identifizierung der Gefahren und gefährlichen Situationen in Zusammenhang mit diesen Produkten, zur Abschätzung und Beurteilung der sich ergebenden Risiken, zur Kontrolle dieser Risiken und zur Überwachung der Wirksamkeit dieser Kontrolle. Zusätzlich hierzu umreißt er den Entscheidungsprozess für die Abschätzung des Restrisikos, indem sie das Restrisiko, wie in ISO 14971 definiert, und den erwarteten medizinischen Nutzen verglichen mit verfügbaren Alternativen einander gegenüberstellt. Dieser Teil von ISO 22442 legt Anforderungen und Anleitungen für das Risikomanagement in Bezug auf typische Gefährdungen durch Medizinprodukte fest, die unter Verwendung tierischer Gewebe und deren Derivate hergestellt wurden, wie z. B.
a) Verunreinigungen durch Bakterien, Schimmelpilze oder Hefepilze;
b) Verunreinigungen durch Viren;
c) Verunreinigungen durch Erreger, die übertragbare spongiforme Enzephalopathie (en: Transmissible Spongiform Encephalopathy, TSE) hervorrufen;
d) für ungewünschte pyrogene, immunologische oder toxikologische Reaktionen verantwortliches Material.
Bei Parasiten und anderen nicht klassifizierten pathogenen Einheiten können ähnliche Prinzipien gelten.
Dieser Teil von ISO 22442 legt keine Anforderungen für die Akzeptanz fest, weil diese von einer Vielzahl von Faktoren bestimmt und deshalb in einer solchen Internationalen Norm nicht festgelegt werden können. Ausgenommen sind bestimmte Derivate, die in Anhang C erwähnt werden. Anhang C legt Anforderungen für die Risikobewertung bei Talg-Derivaten, Kohle aus tierischem Ausgangsmaterial, Milch und Milch-Derivaten, Derivaten von Wolle und Aminosäuren fest.
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO 22442-1:2007)
L'ISO 22442-1:2007 s'applique aux dispositifs médicaux autres que des dispositifs médicaux de diagnostic in vitro, dans la fabrication desquels entrent des matériaux d'origine animale non viables ou rendus non viables. Associée à l'ISO 14971, elle spécifie un mode opératoire permettant d'identifier les phénomènes dangereux et les situations dangereuses associés à de tels dispositifs, d'estimer et d'évaluer les risques qui en découlent, de maîtriser ces risques et de surveiller l'efficacité de cette maîtrise. En outre, elle décrit le processus décisionnel relatif à l'acceptabilité du risque résiduel, en tenant compte du rapport entre le risque résiduel, tel que défini dans l'ISO 14971 et le bénéfice médical escompté par rapport aux solutions de remplacement disponibles. La présente partie de l'ISO 22442 est destinée à fournir des exigences et des directives pour la gestion des risques associés aux phénomènes dangereux typiques présentés par les dispositifs médicaux dans la fabrication desquels entrent des tissus ou des dérivés d'origine animale et notamment
la contamination par des bactéries, moisissures ou levures
la contamination par des virus,
la contamination par des agents responsables d'Encéphalopathies Spongiformes Transmissibles (EST),
un matériau provoquant des réactions pyrogènes, immunologiques ou toxicologiques indésirables.
Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 1. del: Uporaba obvladovanja tveganja (ISO 22442-1:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2008
1DGRPHãþD
SIST EN 12442-1:2001
0HGLFLQVNLSULSRPRþNLNLXSRUDEOMDMRåLYDOVNDWNLYDLQQMLKRYHGHULYDWHGHO
8SRUDEDREYODGRYDQMDWYHJDQMD ,62
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk
management (ISO 22442-1:2007)
Tierische Gewebe und deren Derivate nutzende Medizinprodukte - Teil 1: Anwendung
des Risikomanagements (ISO 22442-1:2007)
Tissus animaux et leurs dérivés utilisés dans la fabrication des dispositifs médicaux -
Partie 1: Application de la gestion des risques (ISO 22442-1:2007)
Ta slovenski standard je istoveten z: EN ISO 22442-1:2007
ICS:
11.120.01
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 22442-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2007
ICS 11.100.20 Supersedes EN 12442-1:2000
English Version
Medical devices utilizing animal tissues and their derivatives -
Part 1: Application of risk management (ISO 22442-1:2007)
Dispositifs médicaux utilisant des tissus animaux et leurs Tierische Gewebe und deren Derivate, die zur Herstellung
dérivés - Partie 1: Application de la gestion des risques von Medizinprodukten eingesetzt werden - Teil 1:
(ISO 22442-1:2007) Anwendung des Risikomanagements (ISO 22442-1:2007)
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.
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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 22442-1:2007: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Foreword
This document (EN ISO 22442-1:2007) 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 12442-1:2000.
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 22442-1:2007 has been approved by CEN as a EN ISO 22442-1:2007 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
4.1, 4.2, 4.3, 4.4, 4.5, 4.6, Annex C Annex I, 7.1, 7.2, 8.1, 8.2
Annexes C and D Annex of Commission Directive Annexes C and D are dedicated to
2003/32/EC TSE risk, but clauses 4.1, 4.2, 4.3,
4.4 are also relevant
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 22442-1
First edition
2007-12-15
Medical devices utilizing animal tissues
and their derivatives —
Part 1:
Application of risk management
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés —
Partie 1: Application de la gestion des risques
Reference number
ISO 22442-1:2007(E)
©
ISO 2007
ISO 22442-1:2007(E)
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ii © ISO 2007 – All rights reserved
ISO 22442-1:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Risk management process . 3
4.1 General. 3
4.2 Risk analysis . 4
4.3 Risk evaluation. 5
4.4 Risk control . 5
4.5 Evaluation of overall residual risk acceptability .7
4.6 Production and post-production information system . 7
Annex A (informative) Guidance on the application of this part of ISO 22442 . 8
Annex B (informative) Graphical representation of part of the risk management process for
medical devices utilizing animal material . 9
Annex C (normative) Special requirements for some animal materials considering the risk
management for TSE agents . 11
Annex D (informative) Information relevant to the management of TSE risk . 16
Bibliography . 24
ISO 22442-1:2007(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 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 22442-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices,
Subcommittee SC 1, Tissue product safety.
ISO 22442 consists of the following parts, under the general title Medical devices utilizing animal tissues and
their derivatives:
⎯ Part 1: Application of risk management
⎯ Part 2: Controls on sourcing, collection and handling
⎯ Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform
encephalopathy (TSE) agents
iv © ISO 2007 – All rights reserved
ISO 22442-1:2007(E)
Introduction
Certain medical devices utilize materials of animal origin.
Animal tissues and their derivatives are used in the design and manufacture of medical devices to provide
performance characteristics that have been chosen for advantages over non-animal based materials. The
range and quantities of materials of animal origin in medical devices vary. These materials can comprise a
major part of the device (e.g. bovine/porcine heart valves, bone substitutes for use in dental or orthopaedic
applications, haemostatic devices), can be a product coating or impregnation (e.g. collagen, gelatine, heparin),
or can be used in the device manufacturing process (e.g. tallow derivatives such as oleates and stearates,
foetal calf serum, enzymes, culture media).
ISO 14971 is a general standard which specifies a process for a manufacturer by identifying hazards and
hazardous situations associated with medical devices, including in vitro medical devices, to estimate and
evaluate the risks associated with those hazards, to control these risks and to monitor the effectiveness of the
control throughout the life cycle. This part of ISO 22442 provides additional requirements and guidance for the
evaluation of medica
...
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