Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)

This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)

Diese Internationale Norm legt besondere Anforderungen an Implantate für den Hüftgelenkersatz fest. Unter
Berücksichtigung der Sicherheit legt diese Internationale Norm Anforderungen an die vorgesehene Funktion,
Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung, die Bereitstellung
von Informationen durch den Hersteller und Prüfverfahren fest.

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO 21535:2007)

L'ISO 21535:2007 fournit des exigences spécifiques relatives aux prothèses de remplacement de l'articulation de la hanche. En matière de sécurité, la présente Norme internationale spécifie des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant, ainsi que des méthodes d'essai.

Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk (ISO 21535:2007)

Ta mednarodni standard navaja posebne zahteve za umetni kolk. V zvezi z varnostjo ta mednarodni standard določa zahteve za predvideno zmogljivost, obliko, materiale, ovrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec, ter preskusne metode.

General Information

Status
Published
Public Enquiry End Date
09-Mar-2009
Publication Date
11-Jun-2009
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-May-2009
Due Date
30-Jul-2009
Completion Date
12-Jun-2009

RELATIONS

Buy Standard

Standard
SIST EN ISO 21535:2009
English language
19 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 21535:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 21535:2008
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
umetni kolk (ISO 21535:2007)

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-

joint replacement implants (ISO 21535:2007)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences

spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO

21535:2007)
Ta slovenski standard je istoveten z: EN ISO 21535:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 21535:2009 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 21535:2009
---------------------- Page: 2 ----------------------
SIST EN ISO 21535:2009
EUROPEAN STANDARD
EN ISO 21535
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 21535:2007
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants (ISO
21535:2007)

Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum

remplacement d'articulation - Exigences spécifiques Gelenkersatz - Besondere Anforderungen an Implantate für

relatives aux implants de remplacement de l'articulation de den Hüftgelenkersatz (ISO 21535:2007)

la hanche (ISO 21535:2007)
This European Standard was approved by CEN on 12 April 2009.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the

official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21535:2009: E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 21535:2009
EN ISO 21535:2009 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC ...........................................................................................4

---------------------- Page: 4 ----------------------
SIST EN ISO 21535:2009
EN ISO 21535:2009 (E)
Foreword

The text of ISO 21535:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of

the International Organization for Standardization (ISO) and has been taken over as EN ISO 21535:2009 by

Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical

text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn

at the latest by March 2010.

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

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 21535:2007.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive.

For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following

countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech

Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
Endorsement notice

The text of ISO 21535:2007 has been approved by CEN as a EN ISO 21535:2009 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 21535:2009
EN ISO 21535:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide a means of conforming to Essential Requirements of the

New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has

been implemented as a national standard in at least one Member State, compliance with the clauses of this

standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity

with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub- Essential Requirements (ERs) of Qualifying remarks/Notes
clause(s) of this EN Directive 93/42/EEC
4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2 The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard. The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.
5 1, 2, 3, 4, 5, 6, 7.1, 9.1, 9.2 The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard .The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.

6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, 9.1, The part of ER 1 relating to the risk of

9.2 use error is not addressed in this
European Standard .The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.The part of ER
7.4 relating to the regulatory provision
for the verification of the medicinal
product is not addressed in this
European Standard.

7 1, 2, 3, 4, 5, 6, 6a., 7.1, 7.2, 7.3, The part of ER 1 relating to the risk of

use error is not addressed in this
European Standard.
The part of ER 7.1 relating to results of
biophysical and modelling research is
not addressed by this European
Standard.
---------------------- Page: 6 ----------------------
SIST EN ISO 21535:2009
EN ISO 21535:2009 (E)
8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3 The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard.
The part of ER 7.1 relating to results of
biophysical and modelling research is
not addressed by this European
Standard.
9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 Via ISO 14630
The modification of ER 13.3 f is not
addressed in this European Standard.
10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 Via ISO 14630
11 9.1, 13 The part of ER 13.3.a concerning the
information on the authorized
representative is not addressed in this
European Standard.
ER 13.3 f is only partly addressed in
this European Standard: safety issue of
single use.
ER 13.6 q is not addressed by this
International Standard.

NOTE Clauses 4, 5, 6, 7, 8 and subclause 11.5 supplement and are dependent on the corresponding clauses of

ISO 21534.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this standard.
---------------------- Page: 7 ----------------------
SIST EN ISO 21535:2009
---------------------- Page: 8 ----------------------
SIST EN ISO 21535:2009
INTERNATIONAL ISO
STANDARD 21535
Second edition
2007-10-01
Non-active surgical implants — Joint
replacement implants — Specific
requirements for hip-joint replacement
implants
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences spécifiques relatives aux implants de
remplacement de l'articulation de la hanche
Reference number
ISO 21535:2007(E)
ISO 2007
---------------------- Page: 9 ----------------------
SIST EN ISO 21535:2009
ISO 21535:2007(E)
PDF disclaimer

This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but

shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In

downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat

accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation

parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In

the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

COPYRIGHT PROTECTED DOCUMENT
© ISO 2007

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or

ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2007 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 21535:2009
ISO 21535:2007(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

1 Scope ..................................................................................................................................................... 1

2 Normative references ........................................................................................................................... 1

3 Terms and definitions........................................................................................................................... 1

4 Intended performance .......................................................................................................................... 2

5 Design attributes................................................................................................................................... 3

5.1 General................................................................................................................................................... 3

5.2 Tolerances and dimensions ................................................................................................................ 3

5.3 Thickness of UHMWPE in acetabular components and bipolar heads........................................... 3

6 Materials ................................................................................................................................................ 3

7 Design evaluation ................................................................................................................................. 4

7.1 General................................................................................................................................................... 4

7.2 Preclinical evaluation ........................................................................................................................... 4

8 Manufacture........................................................................................................................................... 4

9 Sterilization............................................................................................................................................ 5

10 Packaging .............................................................................................................................................. 5

11 Information to be supplied by the manufacturer............................................................................... 5

11.1 General................................................................................................................................................... 5

11.2 Dimensions............................................................................................................................................ 5

11.3 Structural and functional compatibility of components................................................................... 5

11.4 Marking .................................................................................................................................................. 5

11.5 Information for the patient ................................................................................................................... 6

Annex A (informative) Evaluation of relative angular motion of components............................................. 7

Bibliography ....................................................................................................................................................... 9

© ISO 2007 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 21535:2009
ISO 21535:2007(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 second edition cancels and replaces the first edition (ISO 21535:2002), which has been technically

revised.
iv © ISO 2007 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 21535:2009
ISO 21535:2007(E)
Introduction

There are three levels of International Standard 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-ac
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.