EN ISO 14630:2024
(Main)Non-active surgical implants - General requirements (ISO 14630:2024)
Non-active surgical implants - General requirements (ISO 14630:2024)
This document specifies general requirements for non-active surgical implants, hereafter referred to as implants.
This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards.
NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety.
NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2024)
Dieses Dokument legt allgemeine Anforderungen an nichtaktive chirurgische Implantate fest, die im Folgenden Implantate genannt.
Dieses Dokument gilt nicht für Zahnimplantate, Zahnrestaurations¬materialien, transendodontische und transradikuläre Implantate, intraokulare Linsen, und Implantate, die lebensfähiges tierisches oder menschliches Gewebe verwenden.
In Bezug auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, an Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die durch den Hersteller bereitgestellten Informationen fest sowie Prüfverfahren, um die Einhaltung dieser Anforderungen nachzuweisen.
Die Normen der Ebene 2 und Ebene 3 enthalten oder verweisen auf zusätzliche Anforderungen an spezifische Implantate oder Implantatfamilien.
ANMERKUNG 1 Dieses Dokument fordert vom Hersteller kein Qualitätsmanagementsystem. Allerdings fordern viele Zulassungsbehörden die Anwendung eines Qualitätsmanagementsystems, wie beispielsweise das in ISO 13485 beschriebene, um sicherzustellen, dass das Implantat seine beabsichtigte Funktion und Sicherheit erfüllt.
ANMERKUNG 2 Soweit nicht anderweitig festgelegt, bezieht sich die Benennung „Implantat“ in diesem Dokument auf jede einzelne Komponente eines Systems oder eines modularen Implantats, die gesondert oder als Komponentensatz bereitgestellt wird, sowie auf alle ergänzenden oder zugehörigen Implantate, die dafür ausgelegt sind, die beabsichtigte Funktion zu verbessern.
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2024)
Le présent document spécifie les exigences générales relatives aux implants chirurgicaux non actifs, ci-après appelés implants.
Le présent document ne s'applique ni aux implants dentaires, ni aux produits utilisés en médecine dentaire restauratrice, ni aux implants transendodontiques et transradiculaires, ni aux lentilles intraoculaires, ni aux implants utilisant des tissus animaux ou humains viables.
En matière de sécurité, le présent document spécifie les exigences relatives aux performances prévues, aux caractéristiques de 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, de même qu'aux essais destinés à faire la preuve de la conformité à ces exigences.
Les exigences supplémentaires applicables à des implants ou familles d'implants spécifiques sont données ou citées dans les normes de niveaux 2 et 3.
NOTE 1 Le présent document n'exige pas la mise en place par le fabricant d'un système de management de la qualité. Cependant, de nombreux organismes réglementaires exigent la mise en œuvre d'un système de management de la qualité selon l'ISO 13485 pour assurer que l'implant atteint les performances et la sécurité prévues.
NOTE 2 Dans le présent document, sauf indication contraire, le terme «implant» désigne chaque composant distinct d'un système ou d'un implant modulaire, qu'il soit fourni séparément ou sous la forme d'un ensemble de composants, ainsi que tout implant auxiliaire ou implant associé destiné à améliorer les performances prévues.
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO/FDIS 14630:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 14630:2022
01-november-2022
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO/DIS 14630:2022)
Non-active surgical implants - General requirements (ISO/DIS 14630:2022)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO/DIS 14630:2022)
Implants chirurgicaux non actifs - Exigences générales (ISO/DIS 14630:2022)
Ta slovenski standard je istoveten z: prEN ISO 14630
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14630:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 14630:2022
oSIST prEN ISO 14630:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14630
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-09-16 2022-12-09
Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
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NATIONAL REGULATIONS.
ISO/DIS 14630:2022(E)
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14630
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 14630:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(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 .6
6 Selection of materials . 8
7 Design evaluation . 8
7.1 General . 8
7.2 Pre-clinical evaluation . . 9
7.3 Clinical evaluation and clinical investigation . 10
7.4 Post-market surveillance . 11
8 Manufacture .11
9 Sterilization .12
9.1 Implants supplied sterile .12
9.2 Implants supplied non-sterile .12
9.3 Implants that are resterilizable.12
9.4 Sterilization residuals . 13
10 Packaging.13
10.1 Protection from damage in transport, storage and handling .13
10.2 Maintenance of sterility in transport, storage and handling .13
11 Information supplied by the manufacturer .13
11.1 General .13
11.2 Marking on implants . 14
11.3 Label . 14
11.4 Instructions for use . 16
11.5 Patient record label(s) . 18
11.6 Implant card . . 18
11.7 Implants for special purposes. 19
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .20
Bibliography .25
iii
oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(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 of 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 www.iso.org/
iso/foreword.html.
ISO 14630 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
This fifth edition cancels and replaces the fourth edition (ISO 14630:2012), which has been technically
revised. The main changes compared to the previous edition are as follows:
— revised the scope to clarify that this standard does not apply to implants incorporating viable
animal or human tissue and implants intended to remain in place for less than 30 days;
— added definitions are added for demonstrably similar implant and reference implant to clarify when
data for other implants can be used during pre-clinical and clinical evaluation of the implant under
investigation;
— reorganized list of design attributes in Clause 5 to put then in a more logical sequence;
— revised Clause 6 on selection of material to use a risk analysis as the basis for selection of implant
materials, and to list factors to be taken into account when performing the risk analysis;
— significantly expanded Clause 7 on design evaluation to address pre-clinical evaluation, clinical
evaluation and investigation, and post-market surveillance in more detail;
— expanded Clause 8 on manufacturing to address cleanliness of the implant;
— revised Clause 11 on information supplied by the manufacturer to include new subclause addressing
patient record labels (11.5) and implant card (11.6).
iv
oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(E)
Introduction
This document provides a method of addressing the fundamental principles outlined in ISO/TR 14283
as they apply to non-active surgical implants. It also provides a method that can be used to demonstrate
compliance with applicable regulatory requirements relevant to the general safety and performance of
medical devices as they apply to non-active surgical implants.
There are three levels of standards dealing with non-active surgical implants and related
instrumentation. For the implants themselves, they are as follows, with level 1 being the highest.
Level 1: General requirements for non-active surgical implants.
Level 2: Particular requirements for families of non-active surgical implants.
Level 3: Specific requirements for types of non-active surgical implants.
Level 1 standards include this document which contains requirements that apply to all non-active
surgical implants, ISO 16061, which contains requirement for instruments associated with non-
active surgical implants and ISO 14708-1 which contains requirements for active implants. They also
anticipate that there are additional requirements in the Level 2 and Level 3 standards.
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