SIST EN ISO 10993-18:2020/oprA1:2021

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/DAM 1:2021)

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/DAM 1:2021)

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/DAM 1:2021)

Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja tveganja - Dopolnilo 1: Določitev faktorja negotovosti (ISO 10993-18:2020/DAM 1:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 24-Oct-2021
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 17-Aug-2023
• Due Date: 22-Oct-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: 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: SIST 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-18:2020/oprA1:2021
01-oktober-2021
Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev
lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja
tveganja - Dopolnilo 1: Določitev faktorja negotovosti (ISO 10993-18:2020/DAM
1:2021)

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/DAM 1:2021)

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/DAM 1:2021)

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/DAM
1:2021)
Ta slovenski standard je istoveten z: EN ISO 10993-18:2020/prA1
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-18:2020/oprA1:2021 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/oprA1:2021
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SIST EN ISO 10993-18:2020/oprA1:2021
DRAFT AMENDMENT
ISO 10993-18:2020/DAM 1
ISO/TC 194 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-08-16 2021-11-08
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
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 10993-18:2020/DAM 1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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SIST EN ISO 10993-18:2020/oprA1:2021
ISO 10993-18:2020/DAM 1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 10993-18:2020/oprA1:2021
ISO 10993-18:2020/DAM 1:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

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electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

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on the ISO list of patent declarations received (see www .iso .org/ patents).

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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see the following

URL: www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of

medical devices.
A list of all parts in the ISO 10993 series can be found on the ISO website.
© ISO 2021 – All rights reserved iii
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SIST EN ISO 10993-18:2020/oprA1:2021
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SIST EN ISO 10993-18:2020/oprA1:2021
ISO 10993-18:2020/DAM 1:2021(E)
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
5.6, paragraph below Figure 3, last sentence
Replace Table 3 by Table 4
6.2, Table 3,
In the column “Qualitative” for the example method “Gravimetric”, insert “—”
6.4, Table 4,

In the columns “Qualitative” and “Quantitative” for the example methods “HPLC, with UV, CAD, ELSD and/or

MS*” insert “X” in both columns
Table D.2, Table footnote
Replace the text in the table footnote with the following:
Abbreviations include:
ABS poly(acrylonitrile-butadiene-styrene);
ACN acetonitrile;
AE ethyl acetate;
DCM dichloromethane;
DMF dimethylformamide;
HFIP hexafluoroisopropanol;
PET poly(ethylene terephthalate);
TCB trichlorobenzene;
THF tetrahydrofuran;
MeOH methanol;
EtOH ethanol;
© ISO 2021 – All rights reserved 1
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SIST EN ISO 10993-18:2020/oprA1:2021
ISO 10993-18:2020/DAM 1:2021(E)
iPrOH = isopropyl alcohol.
Table D.2,

In the column “Anti-solvents” for “Polymer” Polystyrene and Styrenics (ABS), replace “can” by “ACN”

Page 52, E.3
Replace E.3 with the following:

Quantification in extractables profiling is achieved by various means which differ with respect to

the accuracy of the estimated and reported concentration, where the accuracy can vary significantly

depending on the quantification means employed. For example, quantification could involve the use

of an internal standard to normalize the responses obtained for all relevant analytes. In such an

approach, one estimates the concentration of each analyte based on the simplifying assumption that

all analytes respond similarly, among themselves and with respect to the internal standard (i.e. all

substances have the same response factor). Depending on the validity of this simplifying assumption,

the concentration estimates thus obtained can have widely differing uncertainties and degrees of

accuracy. If the simplifying assu
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