SIST EN ISO 10993-17:2024/oprA1:2024
(Amendment)Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
Biologische Beurteilung von Medizinprodukten - Teil 17: Toxikologische Risikobewertung von Medizinproduktbestandteilen - Änderung 1 (ISO 10993-17:2023/DAmd 1:2024)
Évaluation biologique des dispositifs médicaux - Partie 17: Appréciation du risque toxicologique des constituants des dispositifs médicaux - Amendement 1 (ISO 10993-17:2023/DAmd 1:2024)
Biološko ovrednotenje medicinskih pripomočkov - 17. del: Toksikološka ocena tveganja sestavin medicinskih pripomočkov - Dopolnilo A1 (ISO 10993-17:2023/DAmd 1:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2024
Biološko ovrednotenje medicinskih pripomočkov - 17. del: Toksikološka ocena
tveganja sestavin medicinskih pripomočkov - Dopolnilo A1 (ISO 10993-
17:2023/DAmd 1:2024)
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of
medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
Biologische Beurteilung von Medizinprodukten - Teil 17: Toxikologische Risikobewertung
von Medizinproduktbestandteilen - Änderung 1 (ISO 10993-17:2023/DAmd 1:2024)
Évaluation biologique des dispositifs médicaux - Partie 17: Appréciation du risque
toxicologique des constituants des dispositifs médicaux - Amendement 1 (ISO 10993-
17:2023/DAmd 1:2024)
Ta slovenski standard je istoveten z: EN ISO 10993-17:2023/prA1
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.
DRAFT
Amendment
ISO 10993-17:2023/
DAM 1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 17:
2024-07-31
Toxicological risk assessment of
Voting terminates on:
medical device constituents 2024-10-23
AMENDMENT 1
Évaluation biologique des dispositifs médicaux —
Partie 17: Appréciation du risque toxicologique des constituants
des dispositifs médicaux
AMENDEMENT 1
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
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This document is circulated as received from the committee secretariat.
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Reference number
ISO 10993-17:2023/DAM 1:2024(en)
DRAFT
ISO 10993-17:2023/DAM 1:2024(en)
Amendment
ISO 10993-17:2023/
DAM 1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 17:
Toxicological risk assessment of
Voting terminates on:
medical device constituents
AMENDMENT 1
Évaluation biologique des dispositifs médicaux —
Partie 17: Appréciation du risque toxicologique des constituants
des dispositifs médicaux
AMENDEMENT 1
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO 10993-17:2023/DAM 1:2024(en)
ii
ISO 10993-17:2023/DAM 1:2024(en)
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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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).
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Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of
medical devices.
This amendment to ISO 10993-17:2023 refines 7.1 (Note 1), Annex B (B.1, Table B.1, B.2, B.3) Annex E (items
b) and c) in E.1, Table E.2, and E.3.1).
A list of all parts in the ISO 10993 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iii
ISO 10993-17:2023/DAM 1:2024(en)
Biological evaluation of medical devices —
Part 17:
Toxicological risk assessment of medical device constituents
AMENDMENT 1
2 Normative references
Add a footnote to the following reference:
ISO 10993-18:2020 , Biological evaluation of medical devices — Part 18: Chemical characterization of medical
device materials within a risk management process
Footnote 1: As impacted by ISO 10993-18:2020/Amd1: 2022, Biological evaluation of medical Devices - Chemical
characterization of medical device materials within a risk management process Amendment 1: Determination of
the uncertainty factor.
5.2, Figure 2
In the first diamond, remove ‘TQ>TSL’.
7.1, Note 1
rd
Note 1 to be moved below the 3 paragraph instead of before it.
Annex B, B.1
In the 6th paragraph, replace the 2nd bullet with the following:
— TQ of each constituent present in or on or released from the medical device when the TQ represents
cumulative exposure dose over the duration that the medical device contacts the body.
Annex B, B.1
Below Note 2, replace the 7th paragraph with the following:
Toxicological screening limits shall not apply to devices used for a prolonged or long-term duration in infants
or neonates, including preterm, or the following types of constituents:
Annex B, B.2
In the 1st paragraph, replace the 2nd sentence with the following:
ISO 10993-17:2023/DAM 1:2024(en)
The toxicological screening limit shall be calculated using Formula (B.1).
Annex B, B.2, Table B.1
In the second column heading, replace ‘g/d’ with ‘µg/d’.
Annex B, B.2
Under Formula (B.1), replace the meaning of ‘D’ with the following:
D is the minimum assumed duration (D) of exposure expressed as day(s) (d) for the time period of assumed
exposure considered for the constituent in accordance with ISO 10993-1:2018, 5.3.
Annex B, B.3
In Examples 1-5, replace the meaning of ‘1’ with the following:
Example 1
1 is the minimum number of days that applies to ≤30 d assumed exposure time period (see Table B.1).
Example 2
1 is the minimum number of days that applies to ≤30 d assumed exposure time period (see Table B.1).
Example 3
1 is the minimum number of days that applies to ≤30 d assumed exposure time period (see Table B.1).
Example 4
1 is the minimum number of days that applies to ≤30 d assumed exposure time period (see Table B.1).
Example 5
1 is the minimum number of days that applies to ≤30 d assumed exposure time period (see Table B.1).
Annex B, B.3
Replace the meaning of ‘SF’ for Formula B.2 with the following:
SF is the ratio of the maximum number or quantity (e.g. cm , g or ml) of medical devices that are in contact
with the body during the period of assumed exposure considered that is divided by the number or quantity of
medical device(s) used in the extraction study or information gathered from formulation and manufacturing
process data (e.g., g or mL).
Annex B, B.3
In Example 6, replace the meaning of ‘10’ with the following:
2 2 2
10 is the SF where 500 cm (50 cm x 10 devices) is the maximum device surface area, in cm , that is in
contact with the body divided by the 50 cm device surface area extracted.
Annex E, E.1, b) and c)
ISO 10993-17:2023/DAM 1:2024(en)
In the 1st sentence for each item, replace ‘6.2.1’ with ‘6.2.2’ and replace ‘total quantity’ with ‘maximum total
quantity (TQ , in µg, the cumulative exposure dose)’
max
Annex E, E.2
In the paragraph that follows the legend of Formula E.1, replace the 1st sentence with the following:
When the number of medical devices that contacts the body is more than the number of medical device(s) used
in the release-kinetics study, the reported HQ does not represent the worst-case estimated exposure dose.
r.k.
Annex E, E.3.1
After Formula E.4, replace the 6th paragraph “When the TQ…” with the following:
When the TQ of a constituent is obtained by extraction and quantification methods that are conservative
relative to the medical device intended use, the TQ of each reportable constituent may be assumed to
represent a cumulative exposure dose (TQ ) and is adequate for calculating a worst-case estimated
max
exposure dose, EED .
max
Annex F, F.3
In the second sub-bullet of ‘toxicological screening limit data (see 6.2.2)’, replace ‘TQ’ with ‘TQ ’.
max
Annex F, F.4
rd th th
In the 3 , 5 , and 6 columns of Table F.3, replace ‘TQ’ with ‘TQ ’.
max
Annex F, F.4
In Table F.3, and footnote c, replace ‘total quantity’ with ‘maximum total quantity’.
ISO 10993-17:2023/DAM 1:2024(en)
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 r
...
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