Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

This document 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 Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices.

Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 2: Kontrollen der Beschaffung, Materialgewinnung und Handhabung (ISO 22442-2:2020)

In diesem Dokument werden die Anforderungen an die Kontrolle der Beschaffung, Materialgewinnung und Handhabung (einschließlich Lagerung und Transport) von Tieren und Geweben festgelegt, die zur Herstellung von Medizinprodukten eingesetzt werden, mit Ausnahme von in-vitro-Diagnostika, unter Verwendung von Materialien tierischen Ursprungs. Es kommt dort zum Einsatz, wo der Risikomanagementprozess nach ISO 22442-1 dies vorschreibt.
ANMERKUNG   Die selektive Beschaffung ist beim Risikomanagement in Bezug auf übertragbare spongiforme Enzephalopathie (TSE) besonders wichtig, d. h. falls tierische Gewebe und/oder ihre Derivate die von Rindern, Schafen, oder Ziegenspezies, Hirschen, Elchen, Nerz oder Katze verwendet werden.
Dieses Dokument behandelt nicht die Verwendung menschlichen Gewebes in Medizinprodukten.
Dieses Dokument legt kein Qualitätsmanagementsystem zur Kontrolle aller Produktionsschritte eines Medizinproduktes fest.

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)

Le présent document 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. Il s'applique lorsque cela est requis par le processus de gestion des risques tel que décrit dans l'ISO 22442‑1.
NOTE Le choix de l'origine est jugé particulièrement important pour la gestion des risques d'encéphalopathie spongiforme transmissible (EST), c'est-à-dire lors de l'utilisation de tissus animaux et/ou de leurs dérivés provenant d'espèces bovines, ovines, caprines, de cerfs, d'élans, de visons ou de chats.
Le présent document ne couvre pas l'utilisation de tissus humains dans les dispositifs médicaux.
Le présent document ne spécifie pas un système de management de la qualité permettant le contrôle de toutes les étapes de fabrication de dispositifs médicaux.

Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 2. del: Nadzor pri nabavi, zbiranju in ravnanju z njimi (ISO 22442-2:2020)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
09-Dec-2020
Completion Date
09-Dec-2020

RELATIONS

Buy Standard

Standard
EN ISO 22442-2:2021
English language
26 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 22442-2:2021
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
SIST EN ISO 22442-2:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 22442-2:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 22442-2:2021
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 22442-2:2021
EN ISO 22442-2:2020 (E)
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

---------------------- Page: 4 ----------------------
SIST EN ISO 22442-2:2021
EN ISO 22442-2:2020 (E)
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
---------------------- Page: 5 ----------------------
SIST EN ISO 22442-2:2021
EN ISO 22442-2:2020 (E)

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.
---------------------- Page: 6 ----------------------
SIST EN ISO 22442-2:2021
EN ISO 22442-2:2020 (E)
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.
---------------------- Page: 7 ----------------------
SIST EN ISO 22442-2:2021
EN ISO 22442-2:2020 (E)
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.
---------------------- Page: 8 ----------------------
SIST EN ISO 22442-2:2021
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
---------------------- Page: 9 ----------------------
SIST EN ISO 22442-2:2021
ISO 22442-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 22442-2:2021
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 ..................................................................................................................................................................................................... 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, transport and labelling ........................................................................................................................................................... 6

Annex A (normative) Additional requirements relating to the application of this document

to bovine-sourced materials and other TSE relevant animal species ...........................................................7

Annex B (informative) Certification and attestation ........................................................................................................................13

Bibliography .............................................................................................................................................................................................................................15

© ISO 2020 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 22442-2:2021
ISO 22442-2:2020(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of

medical devices, Subcommittee SC 1, Tissue product safety, in collaboration with the European Committee

for Standardization (CEN) Technical Committee CEN/TC 206, Biological and clinical evaluation of medical

devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).
This third edition cancels and replaces the second edition (ISO 22442-2:2015).
The main changes compared to the previous version are as follows:
— update of the weblink on stunning technique in A.3.2.5 Note 1;

— clarification on scope inclusion of cervid-sourced materials, and other TSE susceptible species;

— clarification on atypical BSE types, especially in combination with intracranial applications;

— enhanced expectation of using validated biochemical testing to establish TSE presence.

A list of all parts in the ISO 22442 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 22442-2:2021
ISO 22442-2:2020(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.

This document is intended to be used in conjunction with the other two parts of the ISO 22442 series.

Local safety regulations can apply. The manufacturers should refer to ISO 22442-3 for information on

the validation of the elimination and/or inactivation of viruses and TSE agents.

It is not a requirement of this document 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 document can form a part of a quality management system conforming to ISO 13485.

© ISO 2020 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 22442-2:2021
---------------------- Page: 14 ----------------------
SIST EN ISO 22442-2:2021
INTERNATIONAL STANDARD ISO 22442-2:2020(E)
Medical devices utilizing animal tissues and their
derivatives —
Part 2:
Controls on sourcing, collection and handling
1 Scope

This document 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 Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk

management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine

species, deer, elk, mink or cats.

This document does not cover the utilization of human tissues in medical devices.

This document does not specify a quality management system for the control of all stages of production

of medical devices.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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, 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.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
collection
removal of tissues from animals
3.2
closed herd

herd governed by standard operating procedures (SOPs) that specify criteria restricting admission of

new animals to ensure that all introduced animals are at the same or higher health standard, compared

to the residents of the herd
Note 1 to entry: Such SOPs typically include:
Note 2 to entry: a) a documented veterinary monitoring process;
© ISO 2020 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 22442-2:2021
ISO 22442-2:2020(E)

Note 3 to entry: b) a fully documented disease history, including a fully documented negligible TSE risk status of

the herd including logged TSE history;

Note 4 to entry: c) a process to prevent feeding of mammalian-derived protein, including a fully documented feed

history, source and traceability;
Note 5 to entry: d) a fully documented breeding history;
Note 6 to entry: e) a fully documented use of veterinary medicines and vaccines;
Note 7 to entry: f) a process of traceability towards each individual animal;

Note 8 to entry: g) a process to control introduction of genetic material from animals outside the closed herd,

including from herds with the deviating TSE status;

Note 9 to entry: h) a fully documented record of animals kept with or in close proximity to the closed herd and

procedures to control vermin or pest.
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 document as determined by the benefit-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.
Compliance is checked by inspection of the appropriate documents, including:

a) specification of the age and 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,

including full traceability to the slaughterhouse.

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);

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;
2 © ISO 2020 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 22442-2:2021
ISO 22442-2:2020(E)

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.
[3],[5]

NOTE The use of risk analysis/risk management tools (such as HACCP, FMEA ) are useful in determining

residual risk.
4.3 Procedures

The documented procedures and instructions required by this document shall be established,

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.