SIST EN ISO 22442-2:2016

SLOVENSKI STANDARD
SIST EN ISO 22442-2:2016
01-februar-2016
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SIST EN ISO 22442-2:2008
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1DG]RUSULQDEDYL]ELUDQMXLQUDYQDQMX,62
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on
sourcing, collection and handling (ISO 22442-2:2015)
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Teil 2: Kontrollen der Beschaffung, Materialgewinnung und
Handhabung (ISO 22442-2:2015)
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 2: Contrôles de
l'origine, de la collecte et du traitement (ISO 22442-2:2015)
Ta slovenski standard je istoveten z: EN ISO 22442-2:2015
ICS:
11.120.01 Farmacija na splošno Pharmaceutics in general
SIST EN ISO 22442-2:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 22442-2:2016

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SIST EN ISO 22442-2:2016


EN ISO 22442-2
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2015
EUROPÄISCHE NORM
ICS 11.100.99 Supersedes EN ISO 22442-2:2007
English Version

Medical devices utilizing animal tissues and their
derivatives - Part 2: Controls on sourcing, collection and
handling (ISO 22442-2:2015)
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 22442-2:2015) Teil 2: Kontrollen der Beschaffung, Materialgewinnung
und Handhabung (ISO 22442-2:2015)
This European Standard was approved by CEN on 31 October 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 22442-2:2015 E
worldwide for CEN national Members.

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SIST EN ISO 22442-2:2016
EN ISO 22442-2:2015 (E)
Contents Page
European foreword . 3
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC. 5

2

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SIST EN ISO 22442-2:2016
EN ISO 22442-2:2015 (E)
European foreword
This document (EN ISO 22442-2:2015) 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 22442-2:2007.
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 22442-1 EN ISO 22442-1:2016 ISO 22442-1:2016

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,
3

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SIST EN ISO 22442-2:2016
EN ISO 22442-2:2015 (E)
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 22442-2:2015 has been approved by CEN as EN ISO 22442-2:2015 without any
modification.
4

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SIST EN ISO 22442-2:2016
EN ISO 22442-2:2015 (E)
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.

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SIST EN ISO 22442-2:2016
EN ISO 22442-2:2015 (E)
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC as
amended by Commission Regulation (EU) No 722/2012
Essential Requirements
(ERs) of
Clause(s)/sub-clause(s) of
Directive 93/42/EEC as Qualifying remarks/Notes
this International Standard
amended by Commission
Regulation No 722/2012
4, 5, 6, 7, 8 and Annex A 7.1 Annex B includes suggested format
for Certificates for animal materials
to be used for medical devices.
Annex C offers advice on the
assessment of veterinary services.
4, 5, 6, 7, 8 and Annex A 7.2 Annex B includes suggested format
for Certificates for animal materials
to be used for medical devices.
Annex C offers advice on the
assessment of veterinary services.
4, 5, 6, 7, 8 and Annex A 8.1 Annex B includes suggested format
for Certificates for animal materials
to be used for medical devices.
Annex C offers advice on the
assessment of veterinary services.
4, 5, 6, 7, 8 and Annex A 8.2 Annex B includes suggested format
for Certificates for animal materials
to be used for medical devices.
Annex C offers advice on the
assessment of veterinary services.
4, 5, 6, 7, 8 and Annex A Annex I of Commission
Regulation No 722/2012

WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.

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SIST EN ISO 22442-2:2016
INTERNATIONAL ISO
STANDARD 22442-2
Second edition
2015-11-01
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 22442-2:2015(E)
©
ISO 2015

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SIST EN ISO 22442-2:2016
ISO 22442-2:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

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SIST EN ISO 22442-2:2016
ISO 22442-2:2015(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 . 3
4.5 Current regulatory requirements and guidance . 4
5 Sourcing . 4
5.1 General . 4
5.2 Species and strain . 4
5.3 Geography . 4
5.4 Inspection . 4
5.5 Certification . 5
5.6 Traceability . 5
6 Collection . 5
7 Handling . 6
8 Storage and transport . 6
Annex A (normative) Additional requirements relating to the application of this part of
ISO 22442 to bovine-sourced materials . 7
Annex B (informative) Certification and attestation .12
Annex C (informative) Veterinary services .14
Bibliography .15
© ISO 2015 – All rights reserved iii

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SIST EN ISO 22442-2:2016
ISO 22442-2:2015(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 194, Biological and clinical evaluation of medical
devices, Subcommittee SC 1, Tissue product safety.
This second edition cancels and replaces the first edition (ISO 22442-2:2007), of which it constitutes a
minor revision.
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
— Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE)
agents and validation assays for those processes [Technical Report]
iv © ISO 2015 – All rights reserved

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SIST EN ISO 22442-2:2016
ISO 22442-2:2015(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).
Tissues and derivatives for use in medical devices are typically obtained by the manufacturer from a
range of sources such as animal herds or flocks and commercial harvesting (including fishing). Some
specialized industries also process materials of animal origin to manufacture a finished product (e.g.
gelatine) which is incorporated as a raw material into the finished medical device by the manufacturer.
To show compliance with this part of ISO 22442, its specified requirements should be fulfilled. The
guidance given in the notes and informative annexes is not normative and is not provided as a checklist
for auditors.
© ISO 2015 – All rights reserved v

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SIST EN ISO 22442-2:2016
INTERNATIONAL STANDARD ISO 22442-2:2015(E)
Medical devices utilizing animal tissues and their
derivatives —
Part 2:
Controls on sourcing, collection and handling
1 Scope
This part of ISO 22442 specifies requirements for controls on the sourcing, collection, and handling
(which includes storage and transport) of animals and tissues for the manufacture of medical devices
utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where
required by the risk management process as described in ISO 22442-1.
NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform
encephalopathy (TSE) risk management.
The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination
and/or inactivation of viruses and TSE agents.
This part of ISO 22442 does not cover the utilization of human tissues in medical devices.
This part of ISO 22442 does not specify a quality management system for the control of all stages of
production of medical devices.
It is not a requirement of this part of ISO 22442 to have a full quality management system during
manufacture, but it does specify requirements for some of the elements of a quality management
system. Attention is drawn to the standards for quality management systems (see ISO 13485) that
control all stages of production or reprocessing of medical devices. The quality management system
elements that are required by this part of ISO 22442 can form a part of a quality management system
conforming to ISO 13485.
NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due
consideration to the requirements and recommendations contained in all three parts of the standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 22442-1:2015, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of
risk management
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22442-1 and the following apply.
3.1
collection
removal of tissues from animals
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SIST EN ISO 22442-2:2016
ISO 22442-2:2015(E)

3.2
low risk herd
closed herd
herd of bovine animals in which, for at least the previous eight years:
a) there has been documented veterinary monitoring;
b) there has been no case of BSE;
c) there has been no feeding of mammalian-derived protein;
d) there is a fully documented breeding history;
e) there is a fully documented use of veterinary medicines and vaccines;
f) each animal is traceable;
g) genetic material has been introduced only from herds with the same BSE-free status
Note 1 to entry: By analogy, low risk herd is applicable to other species naturally affected by TSE. Additional
precautionary measures may be required.
3.3
veterinarian
person designated by the relevant competent authority as suitably qualified for the responsibility
delegated to him or her relating to ante- and post-mortem inspection of animals and/or relevant
certification
Note 1 to entry: Under certain jurisdictions, it is a requirement that the veterinarian be a professionally qualified
person in veterinary medicine.
Note 2 to entry: Under certain jurisdictions, the function of inspection and of certification can be carried
out by different individuals. In such cases, the certificate can be signed by a person who is not designated by
the competent authority. This function is covered in the quality management system of the medical device
manufacturer.
4 General requirements
4.1 General
Apply the requirements of this part of ISO 22442 as determined by the risk assessment (see ISO 22442-1).
Annex A shall be applied as appropriate.
4.2 Quality system elements
A documented system shall be established and maintained to control the quality of materials of animal
origin and shall be verified by the medical device manufacturer. Specific requirements relating to
collection are included in Clause 6.
This system shall address the animal source and the following factors:
a) specification of the geographical origin (such as country or region) of the animal material, state of
health of the animals, and acceptance criteria for animals taking into account the source-species,
perceived risk from pathogens, and ability to obtain appropriate assurances;
NOTE 1 The geographical origin can include the animal’s place of birth and the countries or regions in
which it has lived during its lifetime as well as its place of slaughter. It is advisable that the manufacturer
document the extent to which the geographical origin of the animal can be traced taking into account the
application of risk management (see ISO 22442-1).
2 © ISO 2015 – All rights reserved

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SIST EN ISO 22442-2:2016
ISO 22442-2:2015(E)

b) hygiene and quality assurance requirements to be met by the slaughterer including the provisions
in the slaughterhouse to prevent cross-contamination within and between animals;
c) procedures for the collection, preservation, handling, storage, and transport of materials of
animal origin;
d) documented evidence of the effectiveness of controls defined in a), b), and c);
e) records to be maintained [including as a minimum items a), b), c), and d). See also 5.5].
For the control of processed animal material suppliers, the medical device manufacturer shall document,
to the extent feasible, the practices of the specialized industries to which clauses of the various parts of
ISO 22442 have been applied.
Manufacturers should apply relevant provisions of ISO 22442 to natural substances such as milk, hair,
and wool, although these are not covered by the definition of derivatives.
NOTE 2 The use of risk analysis/risk management tools [such as HACCP, FMEA (see ISO 14971:2007, Annex G)]
are useful in determining residual risk.
4.3 Procedures
The documented procedures and instructions required by this part of ISO 22422 shall be established,
implemented, and maintained. These procedures and instructions shall be approved on issue and shall
be controlled as follows.
The manufacturer shall establish and maintain procedures to control all documents and data that
relate to the requirements of this part of ISO 22442. These documents shall be reviewed and approved
for adequacy by authorized personnel prior to issue.
This control shall ensure that
a) the pertinent issues of appropriate documents are available at all locations where operations
essential to the effective functioning of the quality system are performed, and
b) obsolete documents are promptly removed from all points of issue or use.
Changes to documents shall be reviewed and approved by the same functions/organizations that
performed the original review and approval unless specifically designated otherwise. The designated
organizations shall have access to pertinent background information upon which to base their review
and approval.
Where practicable, the nature of each change shall be identified in the document or the appropriate
attachments.
A master list or equivalent document control procedure shall be established to identify the current
revision of documents in order to preclude the use of non-applicable documents.
4.4 Personnel
Responsibility for the collection, handling, and storage of materials shall be assigned to qualified
personnel as follows.
The manufacturer shall establish and maintain procedures for identifying the training needs and
provide for the training of all personnel performing activities affecting quality.
The manufacturer shall ensure that personnel performing specific assigned tasks are qualified on the
basis of appropriate education, training, and/or experience as required. Appropriate records of training
shall be maintained.
© ISO 2015 – All rights reserved 3

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SIST EN ISO 22442-2:2016
ISO 22442-2:2015(E)

Personnel directly involved in the co
...