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CEN

EN ISO 10993-18:2020/A1:2023

(Amendment)

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)

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)

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)

General Information

Status
Published
Publication Date
25-Jul-2023
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
26-Jul-2023
Completion Date
26-Jul-2023
Directive
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
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
Ref Project
SIST EN ISO 10993-18:2020/A1:2023 - 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)

Relations

Amends
EN 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)
Effective Date
16-Jun-2021

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SLOVENSKI STANDARD
SIST EN ISO 10993-18:2020/A1:2023
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
SIST EN ISO 10993-18:2020/A1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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


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.

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SIST EN ISO 10993-18:2020/A1:2023
EN ISO 10993-18:2020/A1:2023 (E)
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

2

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SIST EN ISO 10993-18:2020/A1:2023
EN ISO 10993-18:2020/A1:2023 (E)
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
...

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