SIST EN ISO 10993-18:2020/A1:2023

SLOVENSKI STANDARD
01-oktober-2023
Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev
lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja
tveganja - Dopolnilo A1: Določitev faktorja negotovosti (ISO 10993-18:2020/Amd
1:2022)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical
device materials within a risk management process - Amendment 1: Determination of the
uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung
von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems -
Änderung 1: Bestimmung des Unsicherheitsfaktors (ISO 10993-18:2020/Amd 1:2022)
Évaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des
matériaux des dispositifs médicaux au sein d'un processus de gestion du risque -
Amendement 1: Détermination du coefficient d'incertitude (ISO 10993-18:2020/Amd
1:2022)
Ta slovenski standard je istoveten z: EN ISO 10993-18:2020/A1:2023
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
18:2020/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2023
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 18:
Chemical characterization of medical device materials
within a risk management process - Amendment 1:
Determination of the uncertainty factor (ISO 10993-
18:2020/Amd 1:2022)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
18: Caractérisation chimique des matériaux des 18: Chemische Charakterisierung von Werkstoffen für
dispositifs médicaux au sein d'un processus de gestion Medizinprodukte im Rahmen eines
du risque - Amendement 1: Détermination du Risikomanagementsystems - Änderung 1: Bestimmung
coefficient d'incertitude (ISO 10993-18:2020/Amd des Unsicherheitsfaktors (ISO 10993-18:2020/Amd
1:2022) 1:2022)
This amendment A1 modifies the European Standard EN ISO 10993-18:2020; it was approved by CEN on 30 April 2022.

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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-18:2020/A1:2023 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 10993-18:2020/A1:2023) 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 10993-18:2020 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by January
2024, and conflicting national standards shall be withdrawn at the latest by January 2024.
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 given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / Regulation(s), 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 10993-18:2020/Amd 1:2022 has been approved by CEN as EN ISO 10993-
18:2020/A1:2023 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 a Commission’s standardization request 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 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
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
10.1 a), b) and h) 5 and 6 This standard provides requirements and
recommendations for the chemical
characterization of medical devices as part of a
risk management process, including a qualitative
characterization of the chemicals and materials
used, a quantitative characterization of the
amounts of chemicals and materials used and an
evaluation of chemical release (leachable and
extractable profile) in both the design and
manufacturing processes. This chemical
characterization can be used to define or confirm
chemical specifications [10.1 h)] and evaluate the
risk of toxicity [10.1 a) and b)] and
biocompatibility [10.1 b)]. Flammability [10.1 a)]
is not covered.
For 10.1 b), ADME (absorption, distribution,
metabolism, and excretion) is not covered. .

For 10.1 h), physical specifications are not
covered.
10.2 5 and 6 This standard provides requirements and
recommendations for the chemical
characterization of medical devices as part of a
risk management process, including an evaluation
of the release of contaminants and residues
(composition, leachable and extractable profile)
in both the design and manufacturing processes.
Packaging is not covered. Aspects of
contaminants and residues during transport and
storage are not covered.
10.4.1 (First paragraph, 5 and 6 This standard provides requirements and
first sentence) recommendations for the chemical
characterization of medical devices as part of a
risk management process, including an evaluation
of chemical substances that may be released from
the medical device (composition, leachable and
extractable profile) in both the design and
manufacturing processes.
Particles and wear debris are not covered.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of medical EN ISO 10993-1:2020
devices — Part 1: Evaluation and
testing within a risk management
process
ISO 10993-17 ISO 10993-17:2002 Biological evaluation of medical EN ISO 10993-17:2009
devices — Part 17: Establishment of
allowable limits for leachable
substances
ISO 14971 ISO 14971:2019 Medical devices — Application of EN ISO 14971:2019
risk management to medical
EN ISO 14971:2019 +
devices
A11:2021
The documents listed in the Column 1 of table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of table ZA.2.
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 10993-18
Second edition
2020-01
AMENDMENT 1
2022-05
Biological evaluation of medical
devices —
Part 18:
Chemical characterization of medical
device materials within a risk
management process
AMENDMENT 1: Determination of the
uncertainty factor
Évaluation biologique des dispositifs médicaux —
Partie 18: Caractérisation chimique des matériaux des dispositifs
médicaux au sein d'un processus de gestion du risque
AMENDEMENT 1: Détermination du coefficient d'incertitude
Reference number
ISO 10993-18:2020/Amd.1:2022(E)
ISO 10993-18:2020/Amd.1:2022(E)
© ISO 2022
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