SIST EN ISO 22442-2:2008
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
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.
Tierische Gewebe und deren Derivate nutzende Medizinprodukte - Teil 2: Kontrollen der Gewinnung, Sammlung und Handhabung (ISO 22442-2:2007)
In dieser Internationalen Norm werden die Anforderungen an die Kontrollen der Gewinnung (Herkunfts¬auswahl), Sammlung und Handhabung (einschließlich Lagerung und Transport) von Tieren und Geweben festgelegt, die eingesetzt werden zur Herstellung von Medizinprodukten, mit Ausnahme von in-vitro-Diagnostika, unter Verwendung von Materialien tierischen Ursprungs.
ANMERKUNG 1 Anforderungen an das Risikomanagement bei der Verwendung von Materialien tierischen Ursprungs in Medizinprodukten sind in ISO 22442 1 beschrieben.
ANMERKUNG 2 Die selektive Gewinnung wird beim Risikomanagement in Bezug auf übertragbare spongiforme Enzephalopathie (TSE) als besonders wichtig angesehen.
ANMERKUNG 3 Die Hersteller sollten für die Validierung der Abreicherung und/oder Inaktivierung von Viren und TSE Erregern ISO 22442 3 beachten.
Diese Internationale Norm behandelt nicht die Verwendung menschlichen Gewebes in Medizinprodukten.
Diese Internationale Norm legt kein Qualitätsmanagementsystem zur Kontrolle aller Produktionsschritte eines Medizinproduktes fest.
ANMERKUNG 4 Es ist keine Anforderung dieser Norm, ein vollständiges Qualitätsmanagementsystem für die Herstellung zu haben. Es wird auf die Normen für Qualitätsmanagementsysteme (siehe ISO 13485) zur Kontrolle aller Schritte der Produktion oder Wiederaufarbeitung von Medizinprodukten hingewiesen.
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)
L'ISO 22442-2:2007 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.
Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 2. del: Nadzor pri nabavi, zbiranju in ravnanju (ISO 22442-2:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22442-2:2008
01-april-2008
1DGRPHãþD
SIST EN 12442-2:2001
0HGLFLQVNLSULSRPRþNLNLXSRUDEOMDMRåLYDOVNDWNLYDLQQMLKRYHGHULYDWHGHO
1DG]RUSULQDEDYL]ELUDQMXLQUDYQDQMX ,62
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
SIST EN ISO 22442-2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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.
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EN ISO 22442-2:2007 (E)
Contents Page
Foreword.3
2
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EN ISO 22442-2:2007 (E)
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.
3
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EN ISO 22442-2:2007 (E)
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.
4
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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
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ISO 22442-2:2007(E)
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ii © ISO 2007 – All rights reserved
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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 2007 – All rights reserved iii
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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 sourcing, collection and handling
⎯ Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform
encephalopathy (TSE) agents
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ISO 22442-2:2007(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.
NOTE 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 2007 – All rights reserved v
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INTERNATIONAL STANDARD ISO 22442-2:2007(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.
NOTE 2 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.
NOTE 3 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 4 A general principle for the application of ISO 22442 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 referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 22442-1:2007, 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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ISO 22442-2:2007(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 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 Under certain jurisdictions it is a requirement that the veterinarian be a professionally qualified person in
veterinary medicine.
NOTE 2 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).
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ISO 22442-2:2007(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.
NOTE 2 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 3 The use of risk analysis/risk management tools (such as HACCP, FMEA, see Annex G of ISO 14971:2007)
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.
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ISO 22442-2:2007(E)
Personnel directly involved in the collection and handling of material of animal origin shall be personnel
employed by the device manufacturer or designated and adequately trained abattoir employees or the
equivalent. The same requirements apply to personnel of all subcontractors.
The manufacturer shall identify the in-house verification requirements, and shall provide adequate resources
and assign trained personnel for verification activities.
Audits shall be carried out by personnel independent of those having direct responsibility for the work being
performed.
4.5 Current regulatory requirements and guidance
Due account shall be taken of relevant current regional regulatory requirements or guidance, including the OIE
International Animal Health Code [4].
5 Sourcing
5.1 General
Subclauses 5.2, 5.3, 5.4, 5.5, 5.6, and Clauses 6, 7 and 8, shall be applied by suppliers of animal materials,
intermediaries and medical device manufacturers as relevant under the risk management plan in compliance
with ISO 22442-1.
The animal material shall not be compromised by cross-contamination before, during or after slaughter.
Animals shall be confirmed as having been declared fit for human consumption (see 5.5).
It is the responsibility of the manufacturer to ensure that the material is fit for its intended use.
5.2 Species and strain
For each material or derivative, the risk of certain diseases is dependent on the animal species and possibly
strain, and this shall be taken into account for the establishment of control measures.
5.3 Geography
The risk of certain diseases is dependent on the geographical origin and this shall be taken into account for
the establishment of control measures.
Geographical origin can include conception, birth, rearing and slaughtering (for bovine species, see Annex A).
If required by the risk management process, in the case of domesticated/farmed species the geographical
region/country of birth and the summary of main locations of residence up to time of slaughter shall be recorded.
In the case of wild species, the region/location of capture and the country/region of birth shall be recorded if
known. The use of wild mammalian species shall be addressed in the risk assessment (see ISO 22442-1).
5.4 Inspection
Sourcing of animal material shall be subject to control and individual inspection by a veterinarian. There will
however be some source-species where this is not possible (e.g. fish, crustaceans). If individual animals
cannot be inspected, the justification for this shall be documented and a relevant sampling plan provided.
Bovine, caprine, cervid, equine, ovine, and porcine species shall be subject to ante-mortem veterinary
inspection. Animals showing locomotive system abnormalities or neurological disorders shall not be used for
the production of medical devices except for tallow derivatives, animal charcoal, and amino acids that are
acceptable as discussed in 4.4.2 and 4.4.3 of ISO 22442-1:2007 due to their processing and not their sourcing.
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ISO 22442-2:2007(E)
Prior to certification, a post-mortem inspection of bovine, caprine, cervid, equine, ovine, and porcine species
shall be performed by a veterinarian immediately after slaughter according to local custom and practice. The
inspection shall include at least:
a) visual inspection;
b) palpation of specified organs;
c) incision of organs and lymph nodes;
d) investigation of anomalies, e.g. inconsistency, colour and smell;
e) if necessary, laboratory tests.
Where indicated by risk assessment, for materials (including pooled blood supplies) for direct use in medical
devices and that are not subject to a validated process to reduce TSE risk in line with ISO 22442-3,
consideration shall be given to the application of a test for the presence of TSE in the source animal.
NOTE Animal tissues derived from certain species (e.g. fish, crustaceans) require a modified approach since
veterinary surveillance is not practicable in the same way as for other animal tissues. Manufacturers should apply relevant
sections of this International Standard to such materials but may need to rely on other procedures which have been shown
to be effective for risk reduction (see ISO 22442-1).
5.5 Certification
Material of animal origin intended for utilization in medical devices shall originate from animals confirmed by a
veterinarian as being fit for human consumption. Records to demonstrate conformance with veterinary
inspection criteria at the abattoir, certificate details and source shall be available (see for example Annex B).
For species where such certification by a veterinarian cannot be obtained, a status equivalent to “fit for human
consumption” is required, such as a confirmation of apparent good health.
5.6 Traceability
Where the risk management undertaken according to ISO 224
...
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