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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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 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 — Correlations between undated normative references and dated EN and ISO standards
Equivalent dated standard
References as listed in the ISO
standard
EN ISO or IEC
a
ISO 10993-1 EN ISO 10993-1:2020 ISO 10993-1:2018
ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009
ISO 10993- 17 EN ISO 10993-17: 2009 ISO 10993-17:2002
a
ISO 10993-18 EN ISO 10993-18:2020 ISO 10993-18:2020
a
Under preparation at European level.
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 10993-12:2021 has been approved by CEN as EN ISO 10993-12:2021 without any
modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
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 General Safety and
Performance Requirements of that Regulation, 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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
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 a General Safety and Performance 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
Annex I of Regulation (EU) 2017/745 [OJ L 117]
General Safety and
Performance Requirements Clause(s)/sub-clause(s) of
Remarks/Notes
of Regulation this EN
(EU) 2017/745
10.2 is only partly covered by this
standard, since the standard does not
provide requirements on design and
manufacture and does not oblige to
minimize risk.
However, this standard provides a
means of preparing samples to assess
conformity with this part of this general
10.2 (first sentence only) 4, 5, 6, 7, 8, 9, 10 and 11
health and safety requirment in
conjunction with other relevant parts of
ISO 10993 for the design and
manufacture of medical devices.
Packaging is not covered.
Risks from residues to person involved
in the transport or storage of medical
devices are not covered.
10.4.1 is only partly covered by this
standard, since the standard does not
provide requirements on design and
manufacture and does not oblige to
minimize risk.
However, this standard provides a
10.4.1 (First paragraph only) 4, 5, 6, 7, 8, 9, 10 and 11 means of preparing samples of medical
devices to assess conformity with this
part of this general health and safety
requirment in conjunction with other
relevant parts of ISO 10993.
Other forms of toxicity are not dealt
with in this standard.
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 product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 10993-12
Fifth edition
2021-01
Biological evaluation of medical
devices —
Part 12:
Sample preparation and reference
materials
Évaluation biologique des dispositifs médicaux —
Partie 12: Préparation des échantillons et matériaux de référence
Reference number
ISO 10993-12:2021(E)
©
ISO 2021
ISO 10993-12:2021(E)
© ISO 2021
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ii © ISO 2021 – All rights reserved
ISO 10993-12:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
5 Reference materials (RMs) . 4
5.1 General . 4
5.2 Certification of RMs for biological safety testing . 4
6 Use of RMs as experimental controls . 4
7 Test sample selection . 5
8 Test sample and RM preparation . 5
9 Selection of representative portions from a medical device . 6
10 Preparation of extracts of sample
...
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