SIST EN ISO 16054:2002
(Main)Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)
This international standard defines minimum data sets to facilitate recording and international exchange of data for the purposes of registry and tracking systems and for retrieval analysis. Minimum data collection requirements are specified for the purpose of implant tracking to allow recall for product correction or patient follow up in the event of unforeseen device malfunction. The minimum data set also fulfils the core data requirements to allow cross referencing between extended data sets for the purposes of retrieval analysis and research.
This international standard is applicable to the manufacturers and distributors of permanently implantable medical devices and to those hospitals and other medical facilities which carry out implant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of permanently implantable medical devices and by hospitals and other medical facilities at both the time of implant and at the time of any subsequent explant procedure.
It is intended that this International Standard provide for the capture of a defined minimum data set for all implant and explant events. This International Standard provides for the timely retrieval of minimum implants data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial numbers, for the purpose of patient follow up.
It is not the intent of this International Standard to provide a means of data recovery which is related to specific medical practioners, medical facilities or manufacturers for purposes other than patient follow up
Chirurgische Implantate - Mindestdatensätze für chirurgische Implantate (ISO 16054:2000)
Diese Europäische Norm legt Mindestdatensätze für chirurgische Implantate zur Vereinfachung von Datenaufzeichnung und internationalem Datenaustausch zum Zweck der Implantatregistrierung und Implantatrückverfolgbarkeit und der Analyse von entnommenen Implantaten fest. Mindestdatensätze werden zum Zweck der Rückverfolgung von Implantaten festgelegt und ermöglichen den Rückruf zur Produktkorrektur oder eine Patienten-Nachbehandlung im Fall unvorhergesehener Implantatfehlfunktionen. Der mindesterforderliche Datensatz erfüllt außerdem die Anforderungen an die Kerndaten, die Querverweisungen zwischen erweiterten Datensätzen zum Zweck der Analyse entnommener Implantate und der Forschung ermöglichen.
Diese Europäische Norm richtet sich an Hersteller und Vertreiber von medizinischen Produkten, die als permanente Implantate, das heißt für eine Dauer von mehr als dreißig Tagen im Körper verbleiben, und an Krankenhäuser und andere medizinische Einrichtungen, die Implantationen durchführen. Die Norm legt Anforderungen an Datensätze fest, die von Herstellern und Vertreibern permanenter implantierbarer medizinischer Produkte und von Krankenhäusern und anderen medizinischen Einrichtungen erfasst werden müssen, sowohl zum Zeitpunkt der Implantation als auch zu jedem möglichen Zeitpunkt einer nachfolgenden Entnahme von Implantaten.
Mit dieser Europäischen Norm soll ein Mindestdatensatz festgelegt werden, der für alle Implantationen und Entnahmen aufgezeichnet werden muss und ebenfalls das rechtzeitige Auffinden von Mindestdatensätzen zum Zweck der Patienten-Nachbehandlung einer bestimmten Patientengruppe, die bestimmte identifizierte Produkte oder Produkte aus einer festgelegten Reihe von Los-, Chargen- oder Seriennummern erhalten hat, ermöglicht.
Diese Europäische Norm hat nicht den Zweck, eine Datenerhebung hinsichtlich bestimmter praktizierender Ärzte, medizinischer
Implants chirurgicaux - Ensembles minimaux de données relatives aux implants chirurgicaux (ISO 16054:2000)
Vsadki (implantati) za kirurgijo - Najmanjša garnitura za kirurške vsadke (implantate) (ISO 16054:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16054:2002
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
SIST EN ISO 16054:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 16054:2002
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SIST EN ISO 16054:2002
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.
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SIST EN ISO 16054:2002
EN ISO 16054:2002 (E)
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).
2
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SIST EN ISO 16054:2002
EN ISO 16054:2002 (E)
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
3
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SIST EN ISO 16054:2002
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SIST EN ISO 16054:2002
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 2000
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SIST EN ISO 16054:2002
ISO 16054:2000(E)
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©
ii ISO 2000 – All rights reserved
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SIST EN ISO 16054:2002
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
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SIST EN ISO 16054:2002
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
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SIST EN ISO 16054:2002
INTERNATIONAL STANDARD ISO 16054:2000(E)
Implants for surgery — Minimum data sets for surgical implants
1 Scope
This I
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