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CEN

prEN ISO 10993-11

(Main)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025)

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO/DIS 10993‑11:2025)

Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO/DIS 10993-11:2025)

ISO 10993-11:2017 spécifie des exigences et fournit des préconisations quant aux modes opératoires à suivre pour évaluer les éventuelles réactions systémiques défavorables causées par les matériaux de dispositifs médicaux.

Biološko ovrednotenje medicinskih pripomočkov - 11. del: Preskusi sistemske toksičnosti (ISO/DIS 10993-11:2025)

General Information

Status
Not Published
Publication Date
25-Oct-2026
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Current Stage
4020 - Submission to enquiry - Enquiry
Start Date
27-Mar-2025
Completion Date
27-Mar-2025
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
oSIST prEN ISO 10993-11:2025 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025)

Relations

Revises
EN ISO 10993-11:2018 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Effective Date
26-Apr-2023

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SLOVENSKI STANDARD
01-maj-2025
Biološko ovrednotenje medicinskih pripomočkov - 11. del: Preskusi sistemske
toksičnosti (ISO/DIS 10993-11:2025)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS
10993-11:2025)
Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische
Toxizität (ISO/DIS 10993-11:2025)
Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique
(ISO/DIS 10993-11:2025)
Ta slovenski standard je istoveten z: prEN ISO 10993-11
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
International
Standard
ISO/DIS 10993-11
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 11: 2025-03-28
Tests for systemic toxicity
Voting terminates on:
2025-06-20
Évaluation biologique des dispositifs médicaux —
Partie 11: Essais de toxicité systémique
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,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 10993-11:2025(en)
DRAFT
ISO/DIS 10993-11:2025(en)
International
Standard
ISO/DIS 10993-11
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 11:
Tests for systemic toxicity
Voting terminates on:
Évaluation biologique des dispositifs médicaux —
Partie 11: Essais de toxicité systémique
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 2025
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
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10993-11:2025(en)
ii
ISO/DIS 10993-11:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations . 3
4.1 General .3
4.2 Selection of animal model .3
4.3 Animal status .4
4.4 Animal care and husbandry .4
4.5 Size and number of groups.4
4.5.1 Size of groups .4
4.5.2 Number of groups .4
4.5.3 Treatment controls .5
4.6 Route of exposure .5
4.7 Sample preparation .5
4.8 Dosing .5
4.8.1 Test sample administration .5
4.8.2 Dosage .6
4.8.3 Dosage frequency .7
4.9 Body weight and food/water consumption .7
4.10 Clinical observations .7
4.11 Clinical pathology .8
4.12 Anatomic pathology .8
4.13 Study designs .8
4.14 Quality of investigation .8
5 Acute systemic toxicity . 9
5.1 General .9
5.2 Study design .9
5.2.1 Preparations .9
5.2.2 Experimental animals .9
5.2.3 Test conditions .10
5.2.4 Body weights . .10
5.2.5 Clinical observations .10
5.2.6 Pathology .10
5.3 Evaluation criteria .11
5.3.1 General .11
5.3.2 Evaluation of results .11
5.4 Final report . 12
6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic
toxicity) .13
6.1 General . 13
6.2 Study design . 13
6.2.1 Preparations . 13
6.2.2 Experimental animals . 13
6.2.3 Test conditions .14
6.2.4 Body weights . .14
6.2.5 Clinical observations .14
6.2.6 Pathology . 15
6.3 Evaluation criteria .16
6.3.1 General .16
6.3.2 Evaluation of results .
...

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