EN ISO 22442-2:2015
(Main)Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
ISO 22442-2:2015 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.
ISO 22442-2:2015 does not cover the utilization of human tissues in medical devices.
ISO 22442-2:2015 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.
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)
L'ISO 22442-2:2015 spécifie les exigences relatives aux contrôles de l'origine, de la collecte et du traitement (qui comprend le stockage et le transport) d'animaux et de tissus destinés à la fabrication de dispositifs médicaux, autres que les dispositifs médicaux de diagnostic in vitro, utilisant des matériaux d'origine animale. Elle s'applique lorsque cela est requis par le processus de gestion des risques tel que décrit dans l'ISO 22442‑1.
NOTE 1 Le choix de l'origine est jugé particulièrement important pour la gestion des risques d'encéphalopathie spongiforme transmissible (EST).
NOTE 2 Il convient que les fabricants se réfèrent à l'ISO 22442‑3 pour les informations relatives à la validation de l'élimination et/ou de l'inactivation des virus et des agents EST.
L'ISO 22442-2:2015 ne couvre pas l'utilisation de tissus humains dans les dispositifs médicaux.
L'ISO 22442-2:2015 ne spécifie pas un système de management de la qualité permettant le contrôle de toutes les étapes de fabrication de dispositifs médicaux.
NOTE 3 L'ISO 22442-2:2015 n'exige pas un système de management de la qualité complet lors de la fabrication, mais elle spécifie des exigences pour la plupart des éléments d'un système de management de la qualité. Il est préférable de se référer aux normes 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. Les éléments du système de management de la qualité qui sont exigés par l'ISO 22442 peuvent former une partie d'un système de management de la qualité en conformité avec l'ISO 13485.
NOTE 4 Un principe général quant à l'application de la présente Norme internationale est qu'il est préférable de donner de l'importance aux exigences et aux recommandations contenues dans les trois parties de la norme.
Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 2. del: Nadzor pri nabavi, zbiranju in ravnanju (ISO 22442-2:2015)
Ta del standarda ISO 22442 določa zahteve za nadzor pri nabavi, zbiranju in ravnanju (vključno s skladiščenjem in transportom) z živalmi in tkivi za proizvodnjo medicinskih pripomočkov iz materialov živalskega izvora, ki niso diagnostični medicinski pripomočki in vitro. Uporablja se na področjih, kjer to zahteva postopek za obvladovanje tveganja, opisan v standardu ISO 22442‑1.
OPOMBA 1: Selektivna nabava je zlasti pomembna za obvladovanje tveganja prenosljive spongiformne encefalopatije.
Proizvajalci naj informacije o validaciji pri izločitvi in/ali inaktivaciji virusov in agensov prenosljive spongiformne encefalopatije poiščejo v standardu ISO 22442‑3.
Ta del standarda ISO 22442 ne zajema uporabe človeških tkiv v medicinskih pripomočkih. Ta del standarda ISO 22442 ne določa sistema vodenja kakovosti za nadzor vseh faz proizvodnje medicinskih pripomočkov. Ta del standarda ISO 22442 ne zahteva popolnega sistema vodenja kakovosti med proizvodnjo, vendar kljub temu določa zahteve za nekatere elemente v sistemu vodenja kakovosti. Izpostavljeni so standardi za sisteme vodenja kakovosti (glejte ISO 13485), ki nadzirajo vse faze proizvodnje ali ponovne obdelave medicinskih pripomočkov. Elementi v sistemu vodenja kakovosti, ki jih zahteva ta del standarda ISO 22442, so lahko del sistema vodenja kakovosti, ki je v skladu s standardom ISO 13485.
OPOMBA 2: Kot splošno načelo za uporabo tega mednarodnega standarda velja, da je priporočljivo upoštevati zahteve in priporočila, navedena v vseh treh delih tega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2016
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SIST EN ISO 22442-2:2008
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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 22442-2:2015) 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,
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.
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 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.
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
ISO 22442-2:2015(E)
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
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 .
...
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