EN ISO 16054:2002

SLOVENSKI STANDARD
01-november-2002
Vsadki (implantati) za kirurgijo - Najmanjša garnitura za kirurške vsadke
(implantate) (ISO 16054:2000)
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)
Chirurgische Implantate - Mindestdatensätze für chirurgische Implantate (ISO
16054:2000)
Implants chirurgicaux - Ensembles minimaux de données relatives aux implants
chirurgicaux (ISO 16054:2000)
Ta slovenski standard je istoveten z: EN ISO 16054:2002
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 16054
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2002
ICS 11.040.40
English version
Implants for surgery - Minimum data sets for surgical implants
(ISO 16054:2000)
Implants chirurgicaux - Ensembles minimaux de données Chirurgische Implantate - Mindestdatensätze für
relatives aux implants chirurgicaux (ISO 16054:2000) chirurgische Implantate (ISO 16054:2000)
This European Standard was approved by CEN on 11 April 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16054:2002 E
worldwide for CEN national Members.

CORRECTED  2002-06-19
Foreword
The text of the International Standard from Technical Committee ISO/TC 150 "Implants for
surgery" of the International Organization for Standardization (ISO) has been taken over as a
European Standard by Technical Committee CEN/TC 285 "Non-active surgical implants", the
secretariat of which is held by NEN.
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 2002, and conflicting national
standards shall be withdrawn at the latest by November 2002.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of the International Standard ISO 16054:2000 has been approved by CEN as a
European Standard without any modification.
NOTE Normative references to International Standards are listed in annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of -
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN Year
ISO 13485 1996 Quality systems - Medical devices - EN ISO 13485 2000
Particular requirements for the
application of EN ISO 9001
INTERNATIONAL ISO
STANDARD 16054
First edition
2000-12-15
Implants for surgery — Minimum data sets
for surgical implants
Implants chirurgicaux — Ensembles minimaux de données relatives aux
implants chirurgicaux
Reference number
ISO 16054:2000(E)
ISO 16054:2000(E)
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©
ii ISO 2000 – All rights reserved

ISO 16054:2000(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 com-
mittees. 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 liai-
son 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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 16054 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
Annex A of this International Standard is for information only.
©
ISO 2000 – All rights reserved iii

ISO 16054:2000(E)
Introduction
The importance and utility of registry, tracking and retrieval analysis systems in understanding long term clinical per-
formance of implant devices and in patient follow up in the event of unforeseen device malfunction is understood.
This International Standard addresses the minimum information concerning the patient, the device manufacturer and
the clinical and surgical procedures which needs to be collected to ensure efficient and rapid international patient fol-
low up should it be required. It also provides the core data set to allow linkage of different registries for the purposes
of retrieval analysis.
Medical device regulators should consider inclusion of these minimum data requirements in the distribution chain to
the end user as a progression of the requirements of ISO 13485.
Users of this International Standard are advised that it is possible to collect all the data items specified in this Inter-
national Standard and, if desired, to transfer them to third party registers using automated methods. An informative
annex to this International Standard provides references to technical standards which define mechanisms for auto-
mation of both data collection and transmission.
©
iv ISO 2000 – All rights reserved

INTERNATIONAL STANDARD ISO 16054:2000(E)
Implants for surgery — Minimum data sets for surgical implants
1 Scope
This I
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