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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)

Biologische Beurteilung von Medizinprodukten - Teil 6: Prüfungen auf lokale Effekte nach Implantationen (ISO/DIS 10993-6:2024)

Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets locaux après implantation (ISO/DIS 10993-6:2024)

Biološko ovrednotenje medicinskih pripomočkov - 6. del: Preskusi, povezani z lokalnimi učinki po implantaciji (ISO/DIS 10993-6:2024)

General Information

Status
Not Published
Public Enquiry End Date
30-Jul-2024
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
VAZ - Healthcare
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
03-Jun-2024
Due Date
21-Oct-2024
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
prEN ISO 10993-6 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)

Relations

Revises
SIST EN ISO 10993-6:2017 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Effective Date
28-Jan-2023

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SLOVENSKI STANDARD
01-julij-2024
Biološko ovrednotenje medicinskih pripomočkov - 6. del: Preskusi, povezani z
lokalnimi učinki po implantaciji (ISO/DIS 10993-6:2024)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
(ISO/DIS 10993-6:2024)
Biologische Beurteilung von Medizinprodukten - Teil 6: Prüfungen auf lokale Effekte
nach Implantationen (ISO/DIS 10993-6:2024)
Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets
locaux après implantation (ISO/DIS 10993-6:2024)
Ta slovenski standard je istoveten z: prEN ISO 10993-6
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 10993-6
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 6: 2024-05-21
Tests for local effects after
Voting terminates on:
2024-08-13
implantation
Évaluation biologique des dispositifs médicaux —
Partie 6: Essais concernant les effets locaux après implantation
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 10993-6:2024(en)
DRAFT
ISO/DIS 10993-6:2024(en)
International
Standard
ISO/DIS 10993-6
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 6:
Tests for local effects after
Voting terminates on:
implantation
Évaluation biologique des dispositifs médicaux —
Partie 6: Essais concernant les effets locaux après implantation
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
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 10993-6:2024(en)
ii
ISO/DIS 10993-6:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Common provisions for implantation test methods . 2
4.1 General .2
4.2 Preparation of samples for implantation .3
4.3 Selection of control materials .4
5 General aspects and requirements for implantation test . 4
5.1 Tissue and implantation site .4
5.2 Animal model .5
5.3 Test periods .6
5.4 Surgery and testing conditions .7
5.5 Evaluation .8
5.5.1 General .8
5.5.2 Macroscopic assessment .8
5.5.3 Implant retrieval and tissue sample collection .9
5.5.4 Microscopic assessment .10
5.5.5 Evaluation of responses .10
6 Test report .11
6.1 General .11
6.2 Test laboratory .11
6.3 Implant samples .11
6.4 Animals and implantation .11
6.5 Retrieval and histological procedure .11
6.6 Macroscopic and microscopic evaluation . 12
6.7 Final evaluation . 12
Annex A (normative) Test methods for implantation in subcutaneous tissue .13
Annex B (normative) Test method for implantation in muscle .15
Annex C (normative) Test method for implantation in bone . 17
Annex D (normative) Test method for implantation in brain tissue .20
Annex E (normative) Test methods for devices contacting peripheral nerve tissue .25
Annex F (informative) Examples of scoring systems used to support the evaluation of local
biological effects after implantation .29
Annex G (informative) Microscopic evaluation of tissue responses to implanted materials .33
Annex ZA (informative) Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .38
Bibliography . 41

iii
ISO/DIS 10993-6:2024(en)
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 committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of 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 patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
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, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 206, Biocompatibility of medical and dental materials and devices, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 10993-6:2016), which has been technically
revised.
The main changes are as follows:
— Informative elements of the scope have been moved to a new introduction clause;
— New definitions for “comparative material”, “coupon”, “euthanasia”, “local effect”, “location marker” and
“steady- state” have been added to clause 3;
— New paragraph on the use of smaller compositionally representative samples or coupons has been added
to 4.2.2;
— New 4.3 “Selection of control materials” has been added;
— Clause 4 and Clause 5 have been revised;
— New Annex E “Test methods for devices contacting peripheral nerve tissue” and Annex G “Microscopic
evaluation of tissue responses to implanted materials” have been added;
— The old Annex E was moved to Annex F;
— Updated entries in the bibliography;
— Document has been revised e
...

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