EN ISO 10993-18:2020
(Main)Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems (ISO 10993-18:2020)
Dieses Dokument legt einen Rahmen für die Identifizierung und gegebenenfalls die Quantifizierung der Bestandteile eines Medizinprodukts fest, welcher die Ermittlung biologischer Gefährdungen und die Abschätzung und Beherrschung der von Bestandteilwerkstoffen ausgehenden biologischen Risiken ermöglicht. Dabei wird ein weitgehend schrittweiser Ansatz für die chemische Charakterisierung angewendet, der einen oder mehrere der folgenden Schritte umfassen kann:
- die Identifizierung der Herstellungswerkstoffe (Konfiguration des Medizinprodukts);
- die Charakterisierung der Herstellungswerkstoffe mittels Identifizierung und Quantifizierung ihrer chemischen Bestandteile (Werkstoffzusammensetzung);
- die Charakterisierung des Medizinproduktes in Bezug auf chemische Substanzen, die während der Herstellung eingeführt wurden (z. B. Formtrennmittel, herstellungsbedingte Verunreinigungen, Sterilisationsrückstände);
- die Abschätzung (unter Labor-Extraktionsbedingungen) des Potentials des Medizinprodukts oder seiner Herstellungswerkstoffe unter klinischen Gebrauchsbedingungen chemische Substanzen freizusetzen (extrahierbare Substanzen);
- die Messung der von einem Medizinprodukt unter seinen klinischen Gebrauchsbedingungen freigesetzten chemischen Substanzen (herauslösbare Substanzen).
Dieses Dokument kann auch zur chemischen Charakterisierung (z. B. zur Identifizierung und/oder Quantifizierung) von Abbauprodukten herangezogen werden. Informationen zu anderen Aspekten der Beurteilung des Abbaus werden in ISO 10993 9, ISO 10993 13, ISO 10993 14 und ISO 10993 15 behandelt.
Die Normenreihe ISO 10993 ist anwendbar, wenn der Werkstoff oder das Medizinprodukt in direkten oder indirekten Kontakt mit dem Körper kommt (zur Kategorisierung nach der Art des Körperkontakts siehe ISO 10993 1).
Dieses Dokument ist zur Unterstützung der Werkstofflieferanten und Hersteller von Medizinprodukten bei der biologischen Beurteilung vorgesehen.
Évaluation biologique des dispositifs médicaux - Partie 18 : Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risque (ISO 10993-18:2020)
Le présent document définit un cadre pour l'identification et, si nécessaire, la quantification des constituants d'un dispositif médical, qui permette l'identification des dangers biologiques ainsi que l'estimation et la maîtrise des risques biologiques liés aux constituants des matériaux, en utilisant une approche généralement progressive de la caractérisation chimique qui peut englober un ou plusieurs des éléments suivants:
— l'identification de ses matériaux constitutifs (configuration du dispositif médical);
— la caractérisation des matériaux constitutifs via l'identification et la quantification de leurs constituants chimiques (composition du matériau);
— la caractérisation du dispositif médical concernant les substances chimiques introduites au cours de la fabrication (par exemple, agents de démoulage, contaminants du procédé, résidus de stérilisation);
— l'estimation (dans les conditions d'extraction en laboratoire) du potentiel du dispositif médical, ou de ses matériaux constitutifs, à libérer des substances chimiques dans des conditions d'utilisation clinique (produits extractibles);
— le dosage des substances chimiques libérées par un dispositif médical dans les conditions d'utilisation clinique qui lui sont propres (produits relargables).
Le présent document peut également être utilisé pour la caractérisation chimique (par exemple, l'identification et/ou la quantification) des produits de dégradation. Les informations relatives aux autres aspects de l'appréciation de la dégradation sont fournies dans l'ISO 10993-9, ISO 10993-13, l'ISO 10993-14 et l'ISO 10993-15.
La série ISO 10993 est applicable lorsque le matériau ou le dispositif médical est en contact direct ou indirect avec le corps (voir l'ISO 10993-1 pour une catégorisation suivant la nature du contact avec le corps du patient).
Le présent document s'adresse aux fournisseurs de matériaux et aux fabricants de dispositifs médicaux, en vue d'étayer une évaluation biologique.
Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja tveganja (ISO 10993-18:2020)
Ta dokument določa okvir za prepoznavanje in po potrebi kvantifikacijo sestavin medicinskega pripomočka, ki omogoča prepoznavanje bioloških nevarnosti ter ocenjevanje in nadzor bioloških tveganj zaradi materialnih sestavin z uporabo na splošno postopnega pristopa k kemični opredelitvi, ki lahko vključuje eno ali več od naslednjega:
– prepoznavanje konstrukcijskih materialov (konfiguracija medicinskega pripomočka);
– opredelitev konstrukcijskih materialov s prepoznavanjem in kvantifikacijo njihovih kemičnih sestavin (sestava materiala);
– opredelitev medicinskega pripomočka za kemične snovi, ki so bile vnesene med proizvodnjo (npr. maziva za ločitev kalupa, procesni kontaminanti, ostanki sterilizacije);
– ocena (s pomočjo pogojev ekstrakcije v laboratoriju) potenciala medicinskega pripomočka ali njegovih konstrukcijskih materialov za sproščanje kemičnih snovi v pogojih klinične uporabe (izvlečki);
– merjenje kemičnih snovi, ki se sproščajo iz medicinskega pripomočka v kliničnih pogojih uporabe (izlužki).
Ta dokument se lahko uporablja tudi za kemično opredelitev (npr. prepoznavanje in/ali kvantifikacijo) razgradnih produktov. Informacije o drugih vidikih ocene razgradnje so zajete v standardih ISO 10993-9, ISO 10993-13, ISO 10993-14 in ISO 10993-15.
Skupina standardov ISO 10993 se uporablja, kadar ima material ali medicinski pripomoček neposreden ali posreden stik s telesom (glej standard ISO 10993-1 za kategorizacijo po naravi stika s telesom).
Ta dokument je namenjen za dobavitelje materialov in proizvajalce medicinskih pripomočkov za podporo pri biološkem ovrednotenju.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2020
Nadomešča:
SIST EN ISO 10993-18:2009
Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev
lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja
tveganja (ISO 10993-18:2020)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical
device materials within a risk management process (ISO 10993-18:2020)
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung
von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems (ISO
10993-18:2020)
Évaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des
matériaux des dispositifs médicaux au sein d'un processus de gestion du risque (ISO
10993-18:2020)
Ta slovenski standard je istoveten z: EN ISO 10993-18:2020
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 10993-18
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-18:2009
English Version
Biological evaluation of medical devices - Part 18:
Chemical characterization of medical device materials
within a risk management process (ISO 10993-18:2020)
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 (ISO 10993-18:2020) Risikomanagementsystems (ISO 10993-18:2020)
This European Standard was approved by CEN on 21 July 2019.
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 10993-18:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
(informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 5
(informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 7
(informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 9
European foreword
This document (EN ISO 10993-18:2020) 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 November 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
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 10993-18:2009.
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, ZB and ZC, which are an 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
Normative references as Equivalent dated standard
listed in Clause 2 of the
EN ISO or IEC
ISO standard
ISO 10993-1 EN ISO 10993-1:2020 ISO 10993-1:2018
ISO 10993-17 EN ISO 10993-17:2009 ISO 10993-17:2002
ISO 14971 EN ISO 14971:2020 ISO 14971:2020
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 10993-18:2020 has been approved by CEN as EN ISO 10993-18:2020 without any
modification.
(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 [Full
reference to the request “M/xxx”] 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 ZC.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 of Clause(s)/sub-clause(s) of
Remarks/Notes
Regulation this EN
(EU) 2017/745
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
10.1 a), b) and h) 5 and 6
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.
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
10.2 5 and 6
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.
This standard provides requirements and
recommendations for the chemical
characterization of medical devices as part of
a risk management process, including an
evaluation of chemical substances that may
10.4.1 (First paragraph, first sentence) 5 and 6
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.
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.
(informative)
Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
This European Standard has been prepared under a Commission’s joint standardization request
M/BC/CEN/89/9 concerning harmonized standards relating to horizontal aspects in the field of medical
devices to provide one voluntary means of conforming to essential requirements of 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 [OJ L 189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive 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 Directive 90/385/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 4, 5, 8, 9 and 10 of the Directive.
NOTE 3 This Annex ZB 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 an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this
European Standard.
Table ZB.1 — Correspondence between this European Standard and Annex I of Directive
90/385/EEC [OJ L 189]
Essential Requirements of Clause(s)/sub-clause(s) Remarks/Notes
Directive 90/385/EEC of this EN
This standard provides
requirements and recommendations
for evaluating 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
9 (only first and second characterization of the amounts of
5 an
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