EN ISO 22442-2:2020

SLOVENSKI STANDARD
01-februar-2021
Nadomešča:
SIST EN ISO 22442-2:2016
Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 2. del:
Nadzor pri nabavi, zbiranju in ravnanju z njimi (ISO 22442-2:2020)
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on
sourcing, collection and handling (ISO 22442-2:2020)
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Teil 2: Kontrollen der Beschaffung, Materialgewinnung und
Handhabung (ISO 22442-2:2020)
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 2: Contrôles de
l'origine, de la collecte et du traitement (ISO 22442-2:2020)
Ta slovenski standard je istoveten z: EN ISO 22442-2:2020
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 22442-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2020
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 22442-2:2015
English Version
Medical devices utilizing animal tissues and their
derivatives - Part 2: Controls on sourcing, collection and
handling (ISO 22442-2:2020)
Dispositifs médicaux utilisant des tissus animaux et Tierische Gewebe und deren Derivate, die zur
leurs dérivés - Partie 2: Contrôles de l'origine, de la Herstellung von Medizinprodukten eingesetzt werden -
collecte et du traitement (ISO 22442-2:2020) Teil 2: Kontrollen der Beschaffung, Materialgewinnung
und Handhabung (ISO 22442-2:2020)
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 22442-2:2020 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 22442-2:2020) 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 22442-2:2015.
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 22442-1 EN ISO 22442-1:2020 ISO 22442-1:2020
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 22442-2:2020 has been approved by CEN as EN ISO 22442-2:2020 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 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 International Standard and Directive 93/42/EEC as
amended by Commission Regulation (EU) No 722/2012
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
Covered for the sourcing, collection
and handling of materials of animal
origin chosen for the manufacture of
7.1 first indent only 4 ,5, 6, 7, 8 and Annex A
medical devices. Not covered for
flammability. Not covered for
manufacture.
Covered for reducing risks to patients
resulting from contaminants as far as
the sourcing, collection and handling
of materials used in medical devices
7.2 first sentence only 4 ,5, 6, 7, 8 and Annex A based on animal tissues and their
derivatives is concerned, providing
any resulting risks are minimized.
Not covered for packing,
manufacture, transport or storage.
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
Covered for reducing risks of
infection to patients as far as the
sourcing, collection and handling of
materials used in medical devices
8.1 based on animal tissues and their
4 ,5, 6, 7, 8 and Annex A
derivatives is concerned, providing
first sentence only
any resulting risks are eliminated or
reduced as far as possible. Not
covered for manufacture.
8.2
Covered for the handling of materials
4 ,5, 6, 7, 8 and Annex A used in medical devices based on
first paragraph of third
animal tissues and their derivatives
paragraph only
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 Art.
Regulation (EU) No 722/2012
4 ,5, 6, 7, 8 and Annex A
1.2.
The Regulation is therefore specific to
TSE risks. Annex I of the Regulation
requires implementation of risk
control measures, including controls
on sourcing, collection and handling
of animal-derived material, to
manage TSE risks.
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 22442-2
Third edition
2020-09
Medical devices utilizing animal
tissues and their derivatives —
Part 2:
Controls on sourcing, collection and
handling
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés —
Partie 2: Contrôles de l'origine, de la collecte et du traitement
Reference number
ISO 22442-2:2020(E)
©
ISO 2020
ISO 22442-2:2020(E)
© ISO 2020
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ii © ISO 2020 – All rights reserved

ISO 22442-2:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General . 2
4.2 Quality system elements . 2
4.3 Procedures . 3
4.4 Personnel .
...