SIST EN ISO 22442-1:2021

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

This document 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 document 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.
This document 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.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1  It is not a requirement of this document 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 document, see Annex A.

Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2020)

Dieses Dokument bezieht sich auf Medizinprodukte, mit Ausnahme von in vitro Diagnostika, hergestellt unter Verwendung von Materialien tierischen Ursprungs, die nicht lebensfähig sind oder abgetötet wurden. Es legt 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 fest. Zusätzlich umschreibt es 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. Dieses Dokument soll Anforderungen und Anleitungen für das Risikomanagement in Bezug auf typische Gefährdungen durch Medizinprodukte bereitstellen, 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 Enzephalopathien (en: transmissible spongiform encephalopathies, TSE) hervorrufen;
d) für ungewünschte pyrogene, immunologische oder toxikologische Reaktionen verantwortliches Material.
Bei Parasiten und anderen nicht klassifizierten pathogenen Einheiten können ähnliche Prinzipien gelten.
Dieses Dokument 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.
Dieses Dokument legt kein Qualitätsmanagementsystem zur Kontrolle aller Produktionsschritte eines Medizinproduktes fest.
Dieses Dokument behandelt nicht die Verwendung von menschlichen Geweben in Medizinprodukten.
ANMERKUNG 1 Es ist keine Anforderung von diesem Dokument, 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 Dokuments ist in Anhang A gegeben.

Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO 22442-1:2020)

Le présent document 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. Associé à l'ISO 14971, il 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, il 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. Le présent document est destiné à fournir des exigences et des préconisations 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.
Des principes similaires peuvent s'appliquer aux parasites et autres entités pathogènes non classées.
Le présent document ne stipule pas de niveaux d'acceptabilité qui, du fait qu'ils sont déterminés par de multiples facteurs, ne peuvent s'inscrire dans une telle Norme internationale, excepté pour certains dérivés particuliers mentionnés à l'Annexe C. L'Annexe C stipule des niveaux d'acceptabilité du risque d'EST pour les dérivés du suif, le noir animal, le lait et les dérivés du lait, les dérivés de la laine et les acides aminés.
Le présent document ne spécifie pas un système de management de la qualité permettant le contrôle de toutes les étapes de fabrication de dispositifs médicaux.
Le présent document ne couvre pas l'utilisation de tissus humains dans les dispositifs médicaux.
NOTE 1    Le présent document n'exige pas un système de management de la qualité complet lors de la fabrication. Toutefois, il est préférable de se référer aux Normes internationales relatives aux systèmes de management de la qualité (voir l'ISO 13485) qui contrôlent toutes les étapes de fabrication ou de retraitement des dispositifs médicaux.
NOTE 2    Voir l'Annexe A pour les préconisations relatives à l'application du présent document.

Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 1. del: Uporaba obvladovanja tveganja (ISO 22442-1:2020)

General Information

• Status: Published
• Public Enquiry End Date: 04-Nov-2018
• Publication Date: 21-Jan-2021
• ICS: 11.040.99 - Other medical equipment
• ICS: 11.100.99 - Other standards related to laboratory medicine
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 07-Jan-2021
• Due Date: 14-Mar-2021
• Completion Date: 22-Jan-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 22442-1:2020 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

Relations

• Replaces: SIST EN ISO 22442-1:2016 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
• Effective Date: 01-Feb-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2021
Nadomešča:
SIST EN ISO 22442-1:2016
Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 1. del:
Uporaba obvladovanja tveganja (ISO 22442-1:2020)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk
management (ISO 22442-1:2020)
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2020)
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application
de la gestion des risques (ISO 22442-1:2020)
Ta slovenski standard je istoveten z: EN ISO 22442-1:2020
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
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
December 2020
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 22442-1:2015
English Version
Medical devices utilizing animal tissues and their
derivatives - Part 1: Application of risk management (ISO
22442-1:2020)
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 22442-1:2020) Teil 1: Anwendung des Risikomanagements (ISO
22442-1:2020)
This European Standard was approved by CEN on 2 December 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22442-1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by Commission Regulation
(EU) No 722/2012 . 5
European foreword
This document (EN ISO 22442-1:2020) has been prepared by Technical Committee ISO/TC 194
"Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” 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 June 2021, and conflicting national standards shall be
withdrawn at the latest by June 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 22442-1:2015.
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 the relationship with EU Directive(s) 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 references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO standards
Normative references as listed in
Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
ISO 10993-1 EN ISO 10993-1:2020 ISO 10993-1:2018
ISO 14971 EN ISO 14971:2019 ISO 14971:2019
ISO 22442-2:2020 EN ISO 22442-2:2020 ISO 22442-2:2020
ISO 22442-3:2007 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, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 22442-1:2020 has been approved by CEN as EN ISO 22442-1:2020 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
Regulation (EU) No 722/2012
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC as
amended by Commission Regulation (EU) No 722/2012
Essential Requirements of Clause(s)/sub-clause(s) of this
Remarks/Notes
Directive 93/42/EEC EN
Covered for the choice of materials
based on animal tissues and their
derivatives with regards to toxicity
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and
7.1 first and second indents and compatibility with biological
Annex C
tissues, cells and body fluids. Not
covered for flammability. Not
covered for manufacture.
Covered for reducing risks to
patients resulting from
contaminants in materials used in
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and
medical devices based on animal
7.2
Annex C
tissues and their derivatives,
providing any resulting risks are
minimized. Not covered for
packing, manufacture, transport or
Essential Requirements of Clause(s)/sub-clause(s) of this
Remarks/Notes
Directive 93/42/EEC EN
storage.
Covered for reducing risks of
infection to patients resulting from
using materials in medical devices
8.1
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and based on animal tissues and their
Annex C derivatives, providing any resulting
First sentence only
risks are eliminated or reduced as
far as possible. Not covered for
manufacture.
Covered only for the veterinary
8.2
control of animals from which
4.2.1.2 d)
tissues and their derivatives have
first paragraph only
been obtained.
The requirements detailed in Section
1 of Annex I of Reg. 722/2012/EC
cover risk analysis and risk
management of medical devices
manufactured utilising non-viable
tissues, or derivatives thereof,
sourced from animals that are
Annex I of Commission
susceptible to TSEs, as defined in
4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and
Regulation (EU) No 722/2012
Art. 1.2. The Regulation is therefore
Annex C
specific to TSE risks.
Annex C is dedicated to TSE risk,
but 4.1, 4.2, 4.3, 4.4, 4.5 and 4.6 are
relevant to the risk analysis and
risk management process required
by the Regulation.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 22442-1
Third edition
2020-09
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 22442-1:2020(E)
©
ISO 2020
ISO 22442-1:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2020 – All rights reserved

ISO 22442-1:2020(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 . 4
4.2.1 Identification of qualitative and quantitative characteristics related to the
safety of medical devices . 4
4.2.2 Identification of hazards and hazardous situations .
...