EN ISO 22442-1:2015
(Main)Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
ISO 22442-1:2015 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. This part of ISO 22442 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
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
ISO 22442-1:2015 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
ISO 22442-1:2015 does not specify a quality management system for the control of all stages of production of medical devices.
ISO 22442-1:2015 does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this part of ISO 22442, see Annex A.
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2015)
Dieser Teil von ISO 22442 bezieht sich auf Medizinprodukte, mit Ausnahme von in-vitro-Diagnostika, hergestellt 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 im Zusammenhang mit diesen Produkten, zur Abschätzung und Beurteilung der sich ergebenden Risiken, zur Kontrolle dieser Risiken und zur Überwachung der Wirksamkeit dieser Kontrolle. Zusätzlich umschreibt er den Entscheidungsprozess für die Annehmbarkeit des Restrisikos, indem das Restrisiko, wie in ISO 14971 definiert, abgewägt und der erwartete medizinische Nutzen, verglichen mit verfügbaren Alternativen, einander gegenübergestellt wird. 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, 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 in einer solchen Internationalen Norm nicht festgelegt werden können. Ausgenommen sind bestimmte Derivate, die in Anhang C erwähnt werden. Anhang C legt Grade für die Annehmbarkeit von TSE-Risiken bei Talg-Derivaten, Kohle aus tierischem Ausgangsmaterial, Milch und Milch-Derivaten, Derivaten von Wolle und Aminosäuren fest.
Dieser Teil von ISO 22442 legt kein Qualitätsmanagementsystem zur Kontrolle aller Produktionsschritte eines Medizinproduktes fest.
Dieser Teil von ISO 22442 gilt nicht für die Verwendung von menschlichen Geweben in Medizinprodukten.
ANMERKUNG 1 Es ist keine Anforderung dieses Teils von ISO 22442, ein vollständiges Qualitätsmanagementsystem für die Herstellung zu nutzen. Es wird jedoch auf Internationale Normen für Qualitätsmanagementsysteme (siehe ISO 13485) zur Kontrolle aller Schritte der Produktion und Wiederaufarbeitung von Medizinprodukten hingewiesen.
ANMERKUNG 2 Eine Anleitung zur Anwendung dieses Teils von ISO 22442 ist in Anhang A gegeben.
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO 22442-1:2015)
L'ISO 22442-1:2015 s'applique aux dispositifs médicaux autres que les 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 dangers 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. L'ISO 22442-1:2015 est destinée à fournir des exigences et des lignes directrices pour la gestion des risques associée aux dangers typiques des dispositifs médicaux dans la fabrication desquels entrent des tissus ou des dérivés d'origine animale, notamment:
a) la contamination par des bactéries, des moisissures ou des levures;
b) la contamination par des virus;
c) la contamination par des agents responsables d'encéphalopathies spongiformes transmissibles (EST);
d) 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 22442-1:2015)
Ta del standarda ISO 22442 se uporablja za medicinske pripomočke, ki niso diagnostični medicinski pripomočki in vitro in so proizvedeni iz neživih ali odmrlih materialov živalskega izvora.
V povezavi s standardom ISO 14971 določa postopek za prepoznavanje tveganj in nevarnih razmer, povezanih s takšnimi pripomočki, za ocenjevanje in ovrednotenje nastalih tveganj ter njihovo obvladovanje, ter za nadzor učinkovitosti tega obvladovanja. Poleg tega opredeljuje postopek odločanja glede sprejemljivosti ostalih tveganj z upoštevanjem uravnoteženosti ostalega tveganja, ki je opredeljena v standardu ISO 14971, ter pričakovane medicinske koristi v primerjavi z razpoložljivimi alternativnimi možnostmi. Ta del standarda ISO 22442 podaja zahteve in smernice za obvladovanje tveganj, značilnih za medicinske pripomočke, proizvedene iz živalskih tkiv ali derivatov, kot so a) kontaminacija z bakterijami, plesnimi ali kvasovkami;
b) kontaminacija z virusi;
c) kontaminacija s povzročitelji, ki povzročajo prenosljive spongiformne encefalopatije (TSE);
d) material, ki povzroča neželene pirogene, imunološke ali toksikološke reakcije.
Za parazite in druge nerazvrščene patogene mikroorganizme je mogoče uporabiti podobna načela. Ta del standarda ISO 22442 ne predpisuje ravni sprejemljivosti, ki jih zaradi vplivanja množice dejavnikov v takšnem mednarodnem standardu ni mogoče opredeliti, razen za nekatere posamezne derivate, omenjene v dodatku C. Dodatek C predpisuje ravni sprejemljivosti tveganja prenosljive spongiformne encefalopatije za derivate iz loja, živalsko oglje, mleko in mlečne derivate, derivate iz volne ter aminokisline. Ta del standarda ISO 22442 ne določa sistema vodenja kakovosti za nadzor vseh faz proizvodnje medicinskih pripomočkov. Ta del standarda ISO 22442 ne zajema uporabe človeških tkiv v medicinskih pripomočkih.
OPOMBA 1: Ta del standarda ISO 22442 ne zahteva popolnega sistema vodenja kakovosti med proizvodnjo. Kljub temu so izpostavljeni mednarodni standardi za sisteme vodenja kakovosti (glejte ISO 13485), ki nadzirajo vse faze proizvodnje ali ponovne obdelave medicinskih pripomočkov.
OPOMBA 2: Za smernice o uporabi tega dela standarda ISO 22442 glejte dodatek A.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2016
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SIST EN ISO 22442-1:2008
0HGLFLQVNLSULSRPRþNLNLXSRUDEOMDMRåLYDOVNDWNLYDLQQMLKRYHGHULYDWHGHO
8SRUDEDREYODGRYDQMDWYHJDQMD ,62
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk
management (ISO 22442-1:2015)
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2015)
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application
de la gestion des risques (ISO 22442-1:2015)
Ta slovenski standard je istoveten z: EN ISO 22442-1:2015
ICS:
11.120.01 Farmacija na splošno Pharmaceutics in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 22442-1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2015
EUROPÄISCHE NORM
ICS 11.100.99 Supersedes EN ISO 22442-1:2007
English Version
Medical devices utilizing animal tissues and their
derivatives - Part 1: Application of risk management (ISO
22442-1:2015)
Dispositifs médicaux utilisant des tissus animaux et Tierische Gewebe und deren Derivate, die zur
leurs dérivés - Partie 1: Application de la gestion des Herstellung von Medizinprodukten eingesetzt werden -
risques (ISO 22442-1:2015) Teil 1: Anwendung des Risikomanagements (ISO
22442-1:2015)
This European Standard was approved by CEN on 1 November 2015.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22442-1:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC. 5
European foreword
This document (EN ISO 22442-1:2015) 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 DIN.
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 May 2016 and conflicting national standards shall be
withdrawn at the latest by May 2016.
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 22442-1:2007.
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, see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 14971 ISO 14971:2012 ISO 14971:2007
ISO 22442-2 EN ISO 22442-2:2016 ISO 22442-2:2016
ISO 22442-3 EN ISO 22442-3:2007 ISO 22442-3:2007
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 22442-1:2015 has been approved by CEN as EN ISO 22442-1:2015 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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 the
Essential Requirements of Directive 93/42/EEC, concerning medical devices, as amended by
Commission Regulation (EU) No722/2012 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 Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA Regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the
risk management process needs to be in compliance with Directive 93/42/EEC, as amended by
2007/47/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest
possible level’, ‘minimized’ or ‘removed’, according to the wording of the corresponding essential
requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with
essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the
European foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed
by this European Standard.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC as
amended by Commission Regulation (EU) No 722/2012
Essential Requirements
(ERs) of Directive
93/42/EEC as amended
Clause(s)/subclause(s) of this Qualifying
by Commission
European Standard remarks/notes
Regulation (EU) No
722/2012
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and
7.1
Annex C
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and
7.2
Annex C
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and
8.1
Annex C
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and
8.2
Annex C
Annexes C and D Annex I of Commission Annexes C and D are
Regulation (EU) No dedicated to TSE risk,
722/2012 but 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
Second edition
2015-11-01
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 22442-1:2015(E)
©
ISO 2015
ISO 22442-1:2015(E)
© ISO 2015, Published in Switzerland
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ISO 22442-1:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Risk management process . 3
4.1 General . 3
4.2 Risk analysis . 3
4.2.1 Identification of qualitative and quantitative characteristics related to the
safety of medical devices . 3
4.2.2 Identification of hazards and hazardous situations . 4
4.3 Risk evaluation . 5
4.4 Risk control . 5
4.4.1 General. 5
4.4.2 Risk control for viruses and TSE agents . 5
4.4.3 Risk control of other hazards . 5
4.4.4 Residual risk evaluation . 6
4.5 Evaluation of overall residual risk acceptability . 6
4.5.1 General. 6
4.5.2 Documentation . 6
4.6 Production and post-production inform
...
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