SIST EN ISO 16054:2019

Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)

This document defines minimum data sets for implants to facilitate recording and international
exchange of data for the purposes of implant tracking systems. This data can also be used to support
retrieval analysis and implant registry.
This document is applicable to the manufacturers and distributors of medical devices intended
for implant via a surgical procedure and to those hospitals and other medical facilities which carry
out implant or explant procedures. It specifies requirements for data items to be recorded by the
manufacturers and distributors of implants and by hospitals and other medical facilities at both the
time of implant event and at the time of any subsequent explant event.
This document is intended to define a minimum data set to be recorded for all implant and explant
events, as well as providing for the timely retrieval of minimum implant data related to specific subsets
of patients who have received specific identified devices or devices within a specified range of lot, batch
or serial codes, for the purpose of patient follow up.
It is not the intent of this document to provide a means of data recovery which is related to specific
medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or
product recall in the event of unforeseen device malfunction.

Chirurgische Implantate - Mindestdatensätze für chirurgische Implantate (ISO 16054:2019)

Dieses Dokument legt Mindestdatensätze für Implantate zur Vereinfachung von Datenaufzeichnung und internationalem Datenaustausch zum Zweck von Rückverfolgungssystemen für Implantate fest. Diese Daten können außerdem verwendet werden, um die Analyse nach Entnahme und die Implantatregistrierung zu unterstützen.
Dieses Dokument richtet sich an Hersteller und Vertreiber von Medizinprodukten, welche zur Implantation mittels chirurgischen Verfahren vorgesehen sind, und an solche Krankenhäuser und andere medizinische Einrichtungen, die Implantationen oder Explantationen durchführen. Es legt Anforderungen an Datensätze fest, die von Herstellern und Vertreibern von Implantaten und von Krankenhäusern und anderen medizinischen Einrichtungen sowohl zum Zeitpunkt der Implantation als auch zum Zeitpunkt jeder nachfolgenden Explantation zu erfassen sind.
Dieses Dokument ist dafür gedacht, einen Mindestdatensatz festzulegen, der für alle Implantationen und Explantationen aufgezeichnet werden muss und ebenfalls das rechtzeitige Auffinden von Mindestdatensätzen des Implantats zum Zweck der Patienten Nachbehandlung einer bestimmten Sub-Patientengruppe, die bestimmte identifizierte Produkte oder Produkte aus einer festgelegten Reihe von Los , Chargen  oder Seriennummern erhalten hat, ermöglicht.
Dieses Dokument ist nicht dafür gedacht, eine Datenerhebung hinsichtlich bestimmter praktizierender Ärzte, medizinischer Einrichtungen oder Hersteller zu ermöglichen, sondern dient ausschließlich der Patienten-Nachbehandlung oder Produktrückrufen bei unvorhergesehener Fehlfunktion.

Implants chirurgicaux - Ensembles minimaux de données relatives aux implants chirurgicaux (ISO 16054:2019)

Le présent document définit des ensembles minimaux de données relatives aux implants afin de faciliter l'enregistrement des données et leur échange au niveau international pour les besoins des systèmes de suivi des implants. Ces données peuvent également être utilisées à l'appui de l'analyse des collectes de données et des registres des implants.
Le présent document s'applique aux fabricants et aux distributeurs de dispositifs médicaux implantables par voie chirurgicale ainsi qu'aux hôpitaux et autres structures médicales procédant à des implantations ou explantations. Il établit les exigences relatives aux données devant être enregistrées par les fabricants et les distributeurs d'implants ainsi que par les hôpitaux et autres structures médicales au moment de l'implantation et de toute explantation ultérieure.
Le présent document est destiné à définir un ensemble minimal de données à enregistrer lors de toute implantation et explantation, et pour les besoins du suivi des patients, il prévoit la récupération ponctuelle de données minimales sur les implants relatives à des groupes de patients spécifiques ayant reçu des dispositifs particuliers identifiés ou des dispositifs ayant des numéros de lot ou de série particuliers.
Le présent document ne prévoit pas de méthode de récupération des données liée à des praticiens, des structures médicales ou des fabricants particuliers pour des besoins autres que le suivi des patients ou le rappel de produits en cas de dysfonctionnement imprévu d'un dispositif.

Vsadki (implantati) za kirurgijo - Najmanjša garnitura za kirurške vsadke (implantate) (ISO 16054:2019)

Ta dokument določa najmanjšo garnituro za kirurške vsadke za lažje beleženje in mednarodno izmenjavo podatkov za potrebe sistemov za sledenje vsadkov. Te podatke je mogoče uporabiti tudi kot podporo za analizo pridobivanja in register vsadkov.
Ta dokument je namenjen proizvajalcem in distributerjem medicinskih pripomočkov, predvidenih za vsaditev s kirurškim posegom, ter bolnišnicam in drugim zdravstvenim ustanovam, ki izvajajo postopke za nameščanje in odstranjevanje vsadkov. Določa zahteve za podatkovne elemente, ki jih beležijo proizvajalci in distributerji vsadkov ter bolnišnice in druge zdravstvene ustanove v času nameščanja vsadka in v času nadaljnjih dogodkov odstranjevanja vsadkov.
Ta dokument je namenjen določanju najmanjše garniture, ki jo je treba zabeležiti za vse dogodke nameščanja in odstranjevanja vsadkov, ter zagotavljanju pravočasnega pridobivanja najmanjše količine podatkov o vsadkih v zvezi z določenimi podskupinami bolnikov, ki so prejeli določene identificirane pripomočke ali pripomočke v določenem razponu serijskih številk ali kod za namene spremljanja bolnikov.
Namen tega dokumenta ni, da bi zagotovil načine obnovitve podatkov v zvezi z določenimi zdravniki, zdravstvenimi ustanovami ali proizvajalci, katere namen ni spremljanje bolnikov ali vpoklic izdelka v primeru nepredvidene okvare pripomočka.

General Information

• Status: Published
• Public Enquiry End Date: 04-Mar-2018
• Publication Date: 03-Sep-2019
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Aug-2019
• Due Date: 14-Oct-2019
• Completion Date: 04-Sep-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 16054:2019 - Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)

Relations

• Replaces: SIST EN ISO 16054:2002 - Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)
• Effective Date: 01-Oct-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16054:2019
01-oktober-2019
Nadomešča:
SIST EN ISO 16054:2002
Vsadki (implantati) za kirurgijo - Najmanjša garnitura za kirurške vsadke
(implantate) (ISO 16054:2019)
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
Chirurgische Implantate - Mindestdatensätze für chirurgische Implantate (ISO
16054:2019)
Implants chirurgicaux - Ensembles minimaux de données relatives aux implants
chirurgicaux (ISO 16054:2019)
Ta slovenski standard je istoveten z: EN ISO 16054:2019
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 16054:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16054:2019

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SIST EN ISO 16054:2019


EN ISO 16054
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2019
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 16054:2002
English Version

Implants for surgery - Minimum data sets for surgical
implants (ISO 16054:2019)
Implants chirurgicaux - Ensembles minimaux de Chirurgische Implantate - Mindestdatensätze für
données relatives aux implants chirurgicaux (ISO chirurgische Implantate (ISO 16054:2019)
16054:2019)
This European Standard was approved by CEN on 23 June 2019.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16054:2019 E
worldwide for CEN national Members.

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SIST EN ISO 16054:2019
EN ISO 16054:2019 (E)
Contents Page
European foreword . 3

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SIST EN ISO 16054:2019
EN ISO 16054:2019 (E)
European foreword
This document (EN ISO 16054:2019) has been prepared by Technical Committee ISO/TC 150 "Implants
for surgery" in collaboration with 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 16054:2002.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16054:2019 has been approved by CEN as EN ISO 16054:2019 without any modification.

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SIST EN ISO 16054:2019

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SIST EN ISO 16054:2019
INTERNATIONAL ISO
STANDARD 16054
Second edition
2019-07
Implants for surgery — Minimum data
sets for surgical implants
Implants chirurgicaux — Ensembles minimaux de données relatives
aux implants chirurgicaux
Reference number
ISO 16054:2019(E)
©
ISO 2019

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SIST EN ISO 16054:2019
ISO 16054:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

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SIST EN ISO 16054:2019
ISO 16054:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Data sets . 3
4.1 General . 3
4.2 Supplier data . 3
4.3 Medical facility data . 3
4.3.1 General. 3
4.3.2 Implant event . 3
4.3.3 Explant event . 4
Annex A (informative) Automated device labelling and data capture . 5
Bibliography . 6
© ISO 2019 – All rights reserved iii

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SIST EN ISO 16054:2019
ISO 16054:2019(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.
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 on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery.
This second edition cancels and replaces the first edition (ISO 16054:2000), which has been technically
revised. The main changes compared to the previous edition are as follows:
— clarification to definitions with the provision of specific examples of the defined terms;
— updated general requirements for data sets with direction on what constitutes an individual
implant;
— inclusion of GTIN and UDI as options for implant identification in data items lists;
— inclusion of expiry date and date of acquisition in supplier data items list;
— defined requirements for data maintenance for medical facilities;
— separated data item lists for medical facilities concerning implant and explant events and identified
items specific to each type of event;
— included cause and situation in the data item list of an explant event;
— updated reference list in Annex A.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

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SIST EN ISO 16054:2019
ISO 16054:2019(E)

Introduction
The importance and utility of registry, tracking and retrieval analysis systems in understanding long
term clinical performance of implants and in patient follow up in the event of unforeseen implant
malfunction is understood.
This document specifies the minimum data collection requirements 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.
It is possible to collect all the data items specified in this document and, if desired, to transfer them to
third party registers using automated methods. Annex A and the Bibliography provide references to
technical standards which define mechanisms for automation of both data collection and transmission.
Annex A
...