SIST EN ISO 10993-12:2021/A1:2025
(Amendment)Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und Referenzmaterialien - ÄNDERUNG 1 (ISO 10993 12:2021/Amd 1:2025)
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence - Amendement 1 (ISO 10993 12:2021/Amd 1:2025)
Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali - Dopolnilo A1 (ISO 10993 12:2021/Amd 1:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in
referenčni materiali - Dopolnilo A1 (ISO 10993 12:2021/Amd 1:2025)
Biological evaluation of medical devices - Part 12: Sample preparation and reference
materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
Biologische Beurteilung von Medizinprodukten - Teil 12: Probenvorbereitung und
Referenzmaterialien - ÄNDERUNG 1 (ISO 10993 12:2021/Amd 1:2025)
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons
et matériaux de référence - Amendement 1 (ISO 10993 12:2021/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 10993-12:2021/A1:2025
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-
EUROPEAN STANDARD
12:2021/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2025
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials - Amendment 1 (ISO
10993 12:2021/Amd 1:2025)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
12: Préparation des échantillons et matériaux de 12: Probenvorbereitung und Referenzmaterialien -
référence - Amendement 1 (ISO 10993 12:2021/Amd Änderung 1 (ISO 10993 12:2021/Amd 1:2025)
1:2025)
This amendment A1 modifies the European Standard EN ISO 10993-12:2021; it was approved by CEN on 24 August 2025.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-12:2021/A1:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4
European foreword
This document (EN ISO 10993-12:2021/A1:2025) 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 Amendment to the European Standard EN ISO 10993-12:2021 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by March
2026, and conflicting national standards shall be withdrawn at the latest by March 2026.
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 has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10993-12:2021/Amd 1:2025 has been approved by CEN as EN ISO 10993-
12:2021/A1:2025 without any modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 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] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
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 and application of the
edition of the normatively referenced standards as given in Table ZA.2 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.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in the Annex Z. For the purpose of using
this standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set
out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
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 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] and to system or process requirements including those
relating to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and Performance Clause(s)/subclause(s) of Remarks/Notes
Requirements of Regulation this EN
(EU) 2017/745
10.1 is only partly covered by this
document, since the document does
not provide requirements on
design and manufacture, nor does
it provide methods to fulfil
characteristics and performance
requirements.
However, this document provides a
means of preparing samples, and
when used in conjunction with
other relevant parts from the EN
ISO 10993 series it can provide
information on “toxicity”, on
10.1 (a), (b) first half sentence
“compatibility with tissues, cells
4, 5, 6, 7, 8, 9, 10 and 11
and (d)
and body fluids” as well as on the
“impact of processes on material
properties”.
Flammability is not covered.
For 10.1 (b), ADME (Absorption,
Distribution, Metabolism and
Excretion) are not covered.
For 10.1 (d), impact of processes on
material properties is covered as
far as they could affect the
biocompatibility, while general
impact on mechanical stability is
not covered.
General Safety and Performance Clause(s)/subclause(s) of Remarks/Notes
Requirements of Regulation this EN
(EU) 2017/745
10.2 is only partly covered by this
document, since the document does
not provide requirements on
design and manufacture and does
not oblige to minimize risk.
However, this document provides a
means of preparing samples to
assess conformi
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