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EN ISO 22442-2:2020

(Main)

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

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
Publication Date
08-Dec-2020
Withdrawal Date
29-Jun-2021
ICS
11.100.20 - Biological evaluation of medical devices
11.100.99 - Other standards related to laboratory medicine
Technical Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Drafting Committee
CEN/TC 316 - Medical devices utilizing tissues
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
09-Dec-2020
Completion Date
09-Dec-2020
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 22442-2:2021 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

Relations

Replaces
EN ISO 22442-2:2015 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
Effective Date
16-Dec-2020

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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.

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SIST EN ISO 22442-2:2021

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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.

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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
2

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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 Assoc
...

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