EN ISO 22442-2:2007

SLOVENSKI STANDARD
01-april-2008
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SIST EN 12442-2:2001
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on
sourcing, collection and handling (ISO 22442-2:2007)
Tierische Gewebe und deren Derivate nutzende Medizinprodukte - Teil 2: Kontrollen der
Gewinnung, Sammlung und Handhabung (ISO 22442-2:2007)
Tissus animaux et leurs dérivés utilisés dans la fabrication des dispositifs médicaux -
Partie 2: Contrôles de l'origine, de la collecte et du traitement (ISO 22442-2:2007)
Ta slovenski standard je istoveten z: EN ISO 22442-2:2007
ICS:
11.120.01
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 22442-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2007
ICS 11.100.20 Supersedes EN 12442-2:2000
English Version
Medical devices utilizing animal tissues and their derivatives -
Part 2: Controls on sourcing, collection and handling (ISO
22442-2:2007)
Dispositifs médicaux utilisant des tissus animaux et leurs Tierische Gewebe und deren Derivate, die zur Herstellung
dérivés - Partie 2: Contrôles de l'origine, de la collecte et du von Medizinprodukten eingesetzt werden - Teil 2:
traitement (ISO 22442-2:2007) Kontrollen der Beschaffung, Materialgewinnung und
Handhabung (ISO 22442-2:2007)
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 22442-2:2007: E
worldwide for CEN national Members.

Contents Page
Foreword.3

Foreword
This document (EN ISO 22442-2:2007) 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 12442-2:2000.
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 22442-2:2007 has been approved by CEN as a EN ISO 22442-2:2007 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, 5, 6, 7, 8, Annex A Annex I, 7.1, 7.2, 8.1, 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, Annex A Annex of Commission Directive
2003/32/EC
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 22442-2
First edition
2007-12-15
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 22442-2:2007(E)
©
ISO 2007
ISO 22442-2:2007(E)
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ISO 22442-2:2007(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 .13
Annex C (informative) Veterinary services . 15
Bibliography . 16

ISO 22442-2:2007(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 22442-2 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 sou
...