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 14630:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2025
Nadomešča:
SIST EN ISO 14630:2013
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2024)
Non-active surgical implants - General requirements (ISO 14630:2024)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2024)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2024)
Ta slovenski standard je istoveten z: EN ISO 14630:2024
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.
EN ISO 14630
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 14630:2012
English Version
Non-active surgical implants - General requirements (ISO
14630:2024)
Implants chirurgicaux non actifs - Exigences générales Nichtaktive chirurgische Implantate - Allgemeine
(ISO 14630:2024) Anforderungen (ISO 14630:2024)
This European Standard was approved by CEN on 17 July 2024.
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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14630:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4
European foreword
This document (EN ISO 14630:2024) 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 June 2025, and conflicting national standards shall be
withdrawn at the latest by June 2025.
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 14630:2012.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14630:2024 has been approved by CEN as EN ISO 14630:2024 without any modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences are indicated in the Annex ZA. For the purpose of using this
standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in
this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
For application of this European standard under Regulation (EU) 2017/745,
1. it is recognized that the normatively referenced ISO 10993-1 includes a dated reference to ISO
14971:2007 which is outdated and for application of this European standard under Regulation (EU)
2017/745 the most recent European version EN ISO 14971:2019 + A11:2021 shall be used;
2. it is recognized that the limits for residuals of ethylene oxide referenced in 9.4 and specified in the
normatively referenced EN ISO 10993-7:2008 + AC 2009 + A1 2022 are not designed for patients
with weight lower than 70 kg and are in particular not appropriate for neonates and other patients
with a weight substantially below 70 kg;
3. it is recognized that the normatively referenced ISO 20857 refers to “applicable clauses of ISO
13485” and that for application of this European standard under Regulation (EU) 2017/745 the
most recent European version EN ISO 13485:2016 + AC:2018 + A11:2021 shall be used.
4. it is recognized that the normatively referenced ISO 22442-1 states in its introduction that it can
only be used in combination with ISO 14971 and is not a “stand-alone” standard and it is also
recognized that for application of this European standard under Regulation (EU) 2017/745 the
most recent European version EN ISO 14971:2019 + A11:2021 shall be used;
5. it is recognized that this European standard does not cover any of the legal requirements of
Regulation (EU) 722/2012 which are applicable to devices or system or process requirements
falling under its scope.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’ or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Differences in definitions of the terms set out in Regulation (EU) 2017/745
Definition in Definition in EN ISO 14630 Explanation
Regulation (EU)
2017/745, Article 2
44 ‘clinical evaluation 3.4 clinical evaluation: Since EN ISO 14630 is based on an
means a systematic international standard, the definition in
set of ongoing activities that
and planned process to the standard is taken from IMDRF MDCE
use scientifically sound
continuously generate, WG/N56FINAL:2019, 4.0.
methods for the assessment
collect, analyse and
and analysis of clinical data to While the exact wording differs, the
assess the clinical data
verify the safety, clinical intent of the definitions seems to be
pertaining to a device
performance and/or mostly identical.
in order to verify the
effectiveness of the device
For the purpose of using this standard in
safety and
when used as intended by the
support of the requirements set out in
performance including
manufacturer
Regulation (EU) 2017/745, the
clinical benefits of the
definitions set out in this Regulation
device when used as
prevail.
intended by the
manufacture’
45 ‘clinical 3.5 clinical investigation Since EN ISO 14630 is based on an
investigation means international standard, the definition in
systematic investigation or
any systematic the standard is taken from IMDRF MDCE
study in or on one or more
investigation involving WG/N56FINAL:2019, 4.0.
human subjects, undertaken to
one or more human
assess the safety, clinical While the exact wording differs, the
subjects undertaken to
performance and/or intent of the definitions seems to be
assess the safety or
effectiveness of a medical mostly identical.
performance of a
device
For the purpose of using this standard in
device’
support of the requirements set out in
Regulation (EU) 2017/745, the
definitions set out in this Regulation
prevail.
30 ‘manufacturer 3.12 manufacturer: Since EN ISO 14630 is based on an
means a natural or international standard, the definition in
natural or legal person with
legal person who the standard is taken from ISO
responsibility for design
manufacturers or fully 14971:2019, 3.9 and was only slightly
and/or manufacture of an
refurbishes a device or modified by replacing "Medical device"
implant (3.14) with the
has a device designed, by "implant".
intention of making the
manufactured or fully
implant available for use, For the purpose of using this standard in
refurbished and
under his name, whether or support of the requirements set out in
markets that device not such an implant is Regulation (EU) 2017/745, the
under its name or designed and/or definitions set out in this Regulation
trademark’ manufactured by that person prevail.
himself or on his behalf by
another person(s)
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Performance Clause(s) / sub-
Requirements of clause(s) Remarks / Notes
Regulation (EU) of this EN
2017/745
23.1 (a) 11.3 23.1 (a) is covered with respect to legibility of the
label by 11.3 (Label) which requires that the
information on the label shall be legible under
illumination of 215 lux using normal vision at a
distance of 1 m.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of medical EN ISO 10993-1:2020
devices — Part 1: Evaluation and
testing within a risk management
process
ISO 10993-7 ISO 10993-7:2008 Biological evaluation of medical EN ISO 10993-7:2008
+ Cor 1:2009 devices — Part 7: Ethylene oxide
+ AC:2009
sterilization residuals
+ Amd 1: 2019
+ A1:2022
ISO 10993-17 ISO 10993-17:2023 Biological evaluation of medical EN ISO 10993-17:2023
device — Part 17: Toxicological
risk assessment of medical device
constituents
ISO 11135 ISO 11135:2014 Sterilization of health care EN ISO 11135:2014
products — Ethylene oxide —
+ Amd 1:2018 + A1:2019
Requirements for the
development, validation and
routine control of a sterilization
process for medical devices
ISO 11137-1 ISO 11137-1:2006 Sterilization of health care EN ISO 11137-1:2015
+ Amd 1:2013 products — Radiation — Part 1:
+ A2:2019
Requirements for development,
+ Amd 2:2018
validation and routine control of a
sterilization process for medical
devices
ISO 11137-2 ISO 11137-2:2013 Sterilization of health care EN ISO 11137-2:2015
+ Amd 1:2022 products — Radiation — Part 2:
+ A1:2023
Establishing the sterilization dose
ISO 11137-3 ISO 11137-3:2017 Sterilization of health care EN ISO 11137-3:2017
products —
...
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