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EN ISO 10993-12:2021

(Main)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
—     test sample selection;
—     selection of representative portions from a medical device;
—     test sample preparation;
—     experimental controls;
—     selection of, and requirements for, reference materials;
—     preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.

Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und Referenzmaterialien (ISO 10993-12:2021)

Das vorliegende Dokument legt Anforderungen fest und gibt Anleitungen zu Verfahren für die Herstellung der Prüfmuster und bei der Auswahl von Referenzmaterialien für die Prüfung von Medizinprodukten vor allem in biologischen Prüfsystemen vor allem nach einem oder mehreren Teilen der Normenreihe ISO 10993.
Das vorliegende Dokument behandelt insbesondere die folgenden Aspekte:
—   Auswahl der Prüfmuster;
—   Auswahl repräsentativer Teile eines Medizinproduktes;
—   Herstellung der Prüfmuster;
—   Kontrollen der Prüfmethoden;
—   Auswahl der und Anforderungen an die Referenzmaterialien;
—   Herstellung der Extrakte.
Das vorliegende Dokument ist nicht anwendbar auf lebende Zellen, kann aber für Materialien und Produktkomponenten von Kombinationsprodukten, die lebende Zellen enthalten, zutreffend sein.
Extraktionen für die chemische Charakterisierung werden in ISO 10993 18 behandelt. Abschnitt 7, Abschnitt 8, Abschnitt 9, Abschnitt 10 [ausgenommen 10.3.5 und 10.3.11 b)] und Abschnitt 11 können für Extraktionen zur chemischen Charakterisierung anwendbar sein. In C.1 bis C.4 enthaltene Informationen können ebenfalls relevant sein.

Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence (ISO 10993-12:2021)

Le présent document spécifie les exigences et fournit des recommandations sur les modes opératoires relatifs à la préparation des échantillons et le choix des matériaux de référence dans le cadre d'essais relatifs aux dispositifs médicaux, dans la mesure où ils sont mis en œuvre principalement dans des systèmes d'essai biologique, essentiellement en conformité avec une ou à plusieurs parties de la série ISO 10993.
Le présent document traite plus spécifiquement des points suivants:
—          le choix des échantillons;
—          le choix des parties représentatives d'un dispositif médical;
—          la préparation des échantillons;
—          les témoins expérimentaux;
—          le choix des matériaux de référence et les exigences qui s'y rapportent;
—          la préparation des extraits.
Le présent document n'est pas applicable aux cellules vivantes, mais il peut s'appliquer aux matériaux ou aux composants de dispositifs médicaux de produits combinés contenant des cellules vivantes.
Les extractions relatives à la caractérisation chimique sont couvertes par l'ISO 10993-18. Les articles 7, 8, 9, 10 [hormis pour 10.3.5 et 10.3.11 b)], et 11 sont applicables aux extractions relatives à la caractérisation chimique. Les informations fournies de C.1 à C.4 peuvent également être pertinentes.

Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:2021)

General Information

Status
Published
Publication Date
15-Jun-2021
Withdrawal Date
30-Dec-2021
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Drafting Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Jun-2021
Completion Date
16-Jun-2021
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN ISO 10993-12:2021 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

Relations

Replaces
EN ISO 10993-12:2012 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
Effective Date
02-May-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-12:2021
01-september-2021
Nadomešča:
SIST EN ISO 10993-12:2012
Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in
referenčni materiali (ISO 10993-12:2021)
Biological evaluation of medical devices - Part 12: Sample preparation and reference
materials (ISO 10993-12:2021)
Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und
Referenzmaterialien (ISO 10993-12:2021)
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons
et matériaux de référence (ISO 10993-12:2021)
Ta slovenski standard je istoveten z: EN ISO 10993-12:2021
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-12:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-12:2021

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SIST EN ISO 10993-12:2021


EN ISO 10993-12
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2021
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-12:2012
English Version

Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials (ISO 10993-12:2021)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
12: Préparation des échantillons et matériaux de 12: Probenvorbereitung und Referenzmaterialien (ISO
référence (ISO 10993-12:2021) 10993-12:2021)
This European Standard was approved by CEN on 15 September 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-12:2021 E
worldwide for CEN national Members.

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SIST EN ISO 10993-12:2021
EN ISO 10993-12:2021 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 5

2

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SIST EN ISO 10993-12:2021
EN ISO 10993-12:2021 (E)
European foreword
This document (EN ISO 10993-12:2021) 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 December 2021, and conflicting national standards
shall be withdrawn at the latest by December 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 10993-12:2012.
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 integral part of this
document.
The following referenced documents are indispensable for t
...

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