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SLOVENSKI STANDARD
oSIST prEN ISO 21535:2021
01-oktober-2021
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
umetni kolk (ISO/DIS 21535:2021)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-
joint replacement implants (ISO/DIS 21535:2021)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Hüftgelenkersatz (ISO/DIS 21535:2021)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation de la hanche
(ISO/DIS 21535:2021)
Ta slovenski standard je istoveten z: prEN ISO 21535
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 21535:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 21535:2021
oSIST prEN ISO 21535:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21535
ISO/TC 150/SC 4 Secretariat: BSI
Voting begins on: Voting terminates on:
2021-07-22 2021-10-14
Non-active surgical implants — Joint replacement implants
— Specific requirements for hip-joint replacement
implants
ICS: 11.040.40
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/DIS 21535:2021(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
oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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Published in Switzerland
ii © ISO 2021 – All rights reserved
oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 6
5 Design attributes . 7
5.1 General . 7
5.2 Tolerances and dimensions . 8
5.2.1 Tolerances and dimensions of taper connections . 8
5.2.2 Tolerances on diameters of articulating surfaces, sphericity of articulating
surfaces and surface finish of articulating surfaces . 8
5.3 Thickness of acetabular components, bipolar heads, and dual mobility heads . 8
5.3.1 General. 8
5.3.2 Thickness of UHMWPE in acetabular components, bipolar heads, and dual
mobility heads . . 9
5.3.3 Thickness of metal and ceramic acetabular shell and acetabular liner
components; and, bipolar heads and dual mobility heads . 9
6 Materials .10
7 Design evaluation .10
7.1 General .10
7.2 Pre-clinical evaluation .10
7.2.1 General.10
7.2.2 Test methods and performance requirements .12
7.3 Clinical investigation .19
8 Manufacture .19
9 Sterilization .19
10 Packaging .19
11 Information to be supplied by the manufacturer .19
11.1 General .19
11.2 Product type and dimensions .20
11.3 Structural and functional compatibility of components .20
11.4 Marking .20
11.5 Information for the patient .20
11.6 Information for the surgeon .21
11.7 Electronic instructions for use .21
Annex A (informative) Evaluation of range of relative angular motion of the femoral and
acetabular components of a total hip replacement .22
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . .25
Bibliography .28
oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(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
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part
2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 21535 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacements.
This third edition cancels and replaces the second edition (ISO 21535:2007), which has been technically
revised.
iv © ISO 2021 – All rights reserved
oSIST prEN ISO 21535:2021
ISO/DIS 21535:2021(E)
Introduction
There are three levels of standards dealing with non-active surgical implants.
These are as follows, with level 1 being the highest:
— level 1: general requirements for non-active surgical implants and instrumentation used in
association with implants;
— level 2: particular requirements for families of non-active surgical implants;
— level 3: specific requirements for types of non-active surgical implant.
This standard is a level 3 standard and contains requirements applying specifically to hip joint
replacements.
The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It
also indicates that there are additional requirements in the level 2 and level 3 standards.
The level 2 standards apply to more restricted sets or families of implants such as those designed for
use in osteosynthesis, cardiovascular surgery or joint replacement. For joint replacement implants the
level 2 standard is ISO 21534.
To address all requirements, it is recommended that a standard of the lowest available level be consulted
first.
oSIST prEN ISO 21535:2021
oSIST prEN ISO 21535:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 21535:2021(E)
Non-active surgical implants — Joint replacement implants
— Specific requirements for hip-joint replacement
implants
1 Scope
This document provides specific requirements for hip joint replacement implants. With regard to
safety, this document specifies requirements for intended performance, design attributes, materials,
design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer,
and methods of test.
This document applies to both total and partial hip joint replacement implants. It applies to components
made of metallic and non-metallic materials.
This document applies to a wide variety of hip replacement implants, but for some specific hip
replacement implant types, some considerations, not specifically covered in this document, may be
applicable. Further details are given in Clause 7.2.1.1.
The requirements which are specified in this document are not intended to require the re-design or
re-testing of devices which have been legally marketed and for which there is a history of sufficient and
safe clinical use. For such devices compliance with this document shall be demonstrated by providing
evidence of the sufficient and safe clinical use.
2 Normative references
The following referenced documents ar
...