SIST EN ISO 10451:2026

Dentistry - Contents of a technical file for dental implant systems (ISO 10451:2026)

This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:
implant body;
implant abutment;
abutment screw;
implant connecting part;
implant connecting part screw;
prosthetic screw;
implant cover screw;
transmucosal healing component.
This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
This document does not apply to the following devices:
dental implants incorporating animal or human components or bioactive characteristics;
custom-made devices that have no pre-fabricated connection;
implantable materials for bone filling and augmentation in oral and maxillofacial surgery;
membrane materials for guided tissue regeneration in oral and maxillofacial surgery;
specific instruments indicated to be used as part of a dental implant system.
NOTE 1        ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2        ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3        Custom-made devices are defined in IMDRF/PMD WG/N49 [5].

Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO 10451:2026)

Dieses Dokument legt Anforderungen an den Inhalt der Technischen Dokumentation fest, die erstellt wird, um die Erfüllung der Zulassungsanforderungen an ein enossales Dentalimplantat nachzuweisen, das Folgendes umfassen kann:
   Implantatkörper;
   Implantatabutment;
   Abutmentschraube;
   Implantat-Verbindungsteil;
   Implantat-Verbindungsteilschraube;
   Befestigungsschraube;
   Implantat-Verschlussschraube;
   transmukosale Einheilkomponente.
Dieses Dokument legt außerdem Anforderungen an Verwendungszweck und Leistung, Konstruktionsmerkmale, Bestandteile, Biokompatibilität, Herstellung, Verpackung, Sterilisation, Haltbarkeit, Kennzeichnung, Etikettierung und Informationen des Herstellers fest.
Dieses Dokument gilt nicht für die folgenden Produkte:
   Dentalimplantate, die tierische oder menschliche Bestandteile oder bioaktive Eigenschaften enthalten;
   maßgefertigte Produkte ohne vorgefertigte Verbindung;
   implantierbare Materialien zum Auffüllen von Knochendefekten und zur Augmentation bei oralen und maxillofazialen Eingriffen;
   Membranmaterialien für die gesteuerte Geweberegeneration bei oralen und maxillofazialen Eingriffen;
   spezifische Instrumente, die als Teil eines Dentalimplantatsystems verwendet werden sollen.
ANMERKUNG 1   ISO 22794 legt den erforderlichen Inhalt der technischen Dokumentation für implantierbare Materialien zum Auffüllen von Knochendefekten und zur Augmentation bei oralen und maxillofazialen Eingriffen fest. ISO 22803 legt den erforderlichen Inhalt der technischen Dokumentation für Membranmaterialien für die gesteuerte Geweberegeneration bei oralen und maxillofazialen Eingriffen fest. Diese Materialien erfordern eine separate technische Dokumentation.
ANMERKUNG 2   ISO 13504 beschreibt die allgemeinen Anforderungen an spezifische Instrumente, die als Teil eines Dentalimplantatsystems verwendet werden sollen. Diese Instrumente erfordern eine separate technische Dokumentation.
ANMERKUNG 3   Maßgefertigte Produkte werden in IMDRF/PMD WG/N49 [5] definiert.

Médecine bucco-dentaire - Contenu du dossier technique pour les systèmes d'implants dentaires (ISO 10451:2026)

Le présent document spécifie les exigences relatives au contenu d’un dossier technique visant à démontrer la conformité aux exigences réglementaires d’un implant dentaire endo-osseux, y compris:
le corps d’implant;
le pilier implantaire;
la vis de fixation de pilier;
l’élément de connexion implantaire;
la vis de l’élément de connexion implantaire;
la vis de prothèse;
la vis de couverture de l’implant;
l’élément de cicatrisation transmuqueux.
Le présent document spécifie également des exigences relatives à l’utilisation prévue et aux performances, aux attributs de conception, aux éléments, à la biocompatibilité, à la fabrication, à l’emballage, à la stérilisation, à la conservation, au marquage, à l’étiquetage et aux informations fournies par le fabricant.
Le présent document ne s’applique pas aux dispositifs suivants:
implants dentaires constitués de composants d’origine animale ou humaine ou ayant des caractéristiques bioactives;
dispositifs sur mesure sans connexion préfabriquée;
matériaux implantables destinés au comblement et à l’augmentation osseux en chirurgie buccale et maxillofaciale;
matériaux membranaires destinés à la régénération tissulaire guidée en chirurgie buccale et maxillofaciale;
instruments spécifiques utilisés dans le cadre d’un système d’implant dentaire.
NOTE 1        L’ISO 22794 spécifie le contenu nécessaire des dossiers techniques relatifs aux matériaux implantables destinés au comblement et à l’augmentation osseux en chirurgie buccale et maxillofaciale. L’ISO 22803 spécifie le contenu nécessaire des dossiers techniques relatifs aux matériaux membranaires destinés à la régénération tissulaire guidée en chirurgie buccale et maxillofaciale. Ces matériaux nécessitent un dossier technique distinct.
NOTE 2        L’ISO 13504 donne les exigences générales relatives aux instruments spécifiques utilisés dans le cadre d’un système d’implant dentaire. Ces instruments nécessitent un dossier technique distinct.
NOTE 3        Les dispositifs sur mesure sont définis dans la recommandation IMDRF/PMD WG/N49 [5].

Zobozdravstvo - Vsebina tehnične mape za sistem zobnih vsadkov (implantatov) (ISO 10451:2026)

Ta dokument določa zahteve za vsebino tehnične dokumentacije, ki dokazuje izpolnjevanje regulativnih zahtev za endoosealni zobni implantat, ki lahko vključuje:
- telo implantata;
- nadgradnjo implantata;
- vijak nadgradnje;
- povezovalni del implantata;
- vijak povezovalnega dela implantata;
- protetični vijak;
- pokrovni vijak implantata;
- transmukozno komponento za celjenje.
Ta dokument prav tako določa zahteve za predvideno uporabo in zmogljivost, oblikovne značilnosti, komponente, biokompatibilnost, proizvodnjo, pakiranje, sterilizacijo, rok uporabnosti, označevanje, etiketiranje in informacije, ki jih zagotavlja proizvajalec.
Ta dokument se ne nanaša na naslednje naprave:
- zobne implantate, ki vključujejo živalske ali človeške komponente ali bioaktivne lastnosti;
- po meri narejene naprave, ki nimajo predizdelane povezave;
- implantabilne materiale za polnjenje kosti in povečanje v oralni in maksilofacialni kirurgiji;
- membranske materiale za vodeno regeneracijo tkiva v oralni in maksilofacialni kirurgiji;
- specifične instrumente, ki so namenjeni za uporabo kot del sistema zobnih implantatov.
OPOMBA 1 ISO 22794 določa potrebno vsebino tehnične dokumentacije za implantabilne materiale za polnjenje kosti in povečanje v oralni in maksilofacialni kirurgiji. ISO 22803 določa potrebno vsebino tehnične dokumentacije za membranske materiale za vodeno regeneracijo tkiva v oralni in maksilofacialni kirurgiji. Ti materiali zahtevajo ločeno tehnično dokumentacijo.
OPOMBA 2 ISO 13504 določa splošne zahteve za specifične instrumente, ki so namenjeni za uporabo kot del sistema zobnih implantatov. Ti instrumenti zahtevajo ločeno tehnično dokumentacijo.
OPOMBA 3 Po meri narejene naprave so opredeljene v IMDRF/PMD WG/N49 [5].

General Information

• Status: Published
• Public Enquiry End Date: 29-Jan-2025
• Publication Date: 16-Apr-2026
• ICS: 11.060.15 - Dental implants
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Apr-2026
• Due Date: 14-Jun-2026
• Completion Date: 17-Apr-2026
• Ref Project: EN ISO 10451:2026 - Dentistry - Contents of a technical file for dental implant systems (ISO 10451:2026)

Relations

• Replaces: SIST EN ISO 10451:2010 - Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
• Effective Date: 01-Jun-2026
• Referred By: SIST EN 1642:2012 - Dentistry - Medical devices for dentistry - Dental implants
• Effective Date: 01-Apr-2026

Overview

FprEN ISO 10451 (ISO/FDIS 10451:2025) specifies the required contents of a technical file for dental implant systems. It defines the documentation manufacturers must compile to demonstrate conformity with regulatory requirements for endosseous dental implants and associated components (implant body, abutment, screws, connecting parts, healing components, etc.). The 2024/2025 edition updates the technical file content to reflect current regulatory expectations, including changes driven by the European Medical Device Regulation, and adds an informative annex listing hazards related to dental implants.

Key topics and requirements

This standard organizes the technical file around practical, compliance-focused elements:

• Device description and specification: device name, images, family variations, intended use, indications/contraindications and patient population.
• Risk analysis: documentation of identified hazards and risk management consistent with regulatory practice.
• Infection and microbial contamination: requirements for demonstrating control of bioburden and sterilization processes.
• Manufacturing information: production methods, cleanroom/classification, surface treatments and coatings.
• Verification and validation: mechanical and functional testing, dynamic loading (e.g., fatigue), corrosion and material verification.
• Clinical evaluation and clinical investigation: clinical data to verify safety and performance.
• Information supplied by the manufacturer: labelling, instructions for use, symbols, and sterilization/packaging instructions.
• Post-market surveillance: procedures for monitoring performance and reporting adverse events.
• Conformity documentation: essential principles checklist and declaration of conformity.

Applications and users

Who uses ISO 10451 and why:

• Medical device manufacturers: to prepare and maintain a compliant technical file for market authorization and audits.
• Regulatory and conformity assessment bodies (CABs/notified bodies): to assess completeness and adequacy of documentation.
• Quality and regulatory affairs teams: to align design, manufacturing and clinical evidence with regulatory expectations (ISO 13485, MDR).
• Clinical researchers and contract testing labs: to understand required clinical evidence and test methods.
  Practical uses include regulatory submissions, supplier audits, design transfers, sterilization validation, and post-market vigilance planning.

Related standards

ISO 10451 references and aligns with other international standards commonly used in dental implant regulatory work, including:

• ISO 13485 (QMS), ISO 14971 (risk management), ISO 10993-1/17 (biocompatibility),
• Sterilization standards ISO 11135 / ISO 11137 / ISO 17665-1, ISO 11607 (packaging),
• ISO 14801 (dynamic loading tests), ISO 20417 (manufacturer information), and IEC 62366-1 (usability).

Keywords: ISO 10451, dental implant systems, technical file, dental implants, regulatory compliance, clinical evaluation, sterilization, biocompatibility.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2026
Nadomešča:
SIST EN ISO 10451:2010
Zobozdravstvo - Vsebina tehnične mape za sistem zobnih vsadkov (implantatov)
(ISO 10451:2026)
Dentistry - Contents of a technical file for dental implant systems (ISO 10451:2026)
Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO
10451:2026)
Médecine bucco-dentaire - Contenu du dossier technique pour les systèmes d'implants
dentaires (ISO 10451:2026)
Ta slovenski standard je istoveten z: EN ISO 10451:2026
ICS:
11.060.15 Zobni implantati Dental implants
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10451
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2026
EUROPÄISCHE NORM
ICS 11.060.15 Supersedes EN ISO 10451:2010
English Version
Dentistry - Contents of a technical file for dental implant
systems (ISO 10451:2026)
Médecine bucco-dentaire - Contenu du dossier Zahnheilkunde - Inhalt der Technischen
technique pour les systèmes d'implants dentaires (ISO Dokumentation für Dentalimplantatsysteme (ISO
10451:2026) 10451:2026)
This European Standard was approved by CEN on 6 March 2026.

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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10451:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10451:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 September 2026, and conflicting national standards
shall be withdrawn at the latest by September 2026.
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 10451:2010.
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 10451:2026 has been approved by CEN as EN ISO 10451:2026 without any modification.

International
Standard
ISO 10451
Third edition
Dentistry — Contents of a technical
2026-03
file for dental implant systems
Médecine bucco-dentaire — Contenu du dossier technique pour
les systèmes d'implants dentaires
Reference number
ISO 10451:2026(en) © ISO 2026
ISO 10451:2026(en)
© ISO 2026
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]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 10451:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 Technical file content and requirements. 3
4.1 General .3
4.2 Device description and specification.4
4.3 Risk analysis .5
4.4 Infection and microbial contamination .5
4.5 Manufacturing information .5
4.6 Verification and validation activities .6
4.7 Clinical evaluation and clinical investigation .7
4.8 Information supplied by the manufacturer .8
4.9 Post market surveillance .9
Annex A (informative) List of identified hazards for dental implants .10
Bibliography .12

iii
ISO 10451:2026(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental
implants, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 10451:2010), which has been technically
revised.
The main changes are as follows:
[1]
— technical file has been reworked to take into account the new European Medical Device Regulation ;
— Annex A has been added.
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 10451:2026(en)
Introduction
Legal and regulatory requirements on the documentation of the design, manufacture and performance of
dental implants are developing in different ways around the world. As the dental implant industry is already
active on a global basis, and is becoming more so, concern is growing as to the need for international and
mutually recognized standards for the documentation of the design and performance of such devices.

v
International Standard ISO 10451:2026(en)
Dentistry — Contents of a technical file for dental implant
systems
1 Scope
This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of
regulatory requirements for an endosseous dental implant that can include:
— implant body;
— implant abutment;
— abutment screw;
— implant connecting part;
— implant connecting part screw;
— prosthetic screw;
— implant cover screw;
— transmucosal healing component.
This document also specifies requirements for intended use and performance, design attributes, components,
biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information
supplied by the manufacturer.
This document does not apply to the following devices:
— dental implants incorporating animal or human components or bioactive characteristics;
— custom-made devices that have no pre-fabricated connection;
— implantable materials for bone filling and augmentation in oral and maxillofacial surgery;
— membrane materials for guided tissue regeneration in oral and maxillofacial surgery;
— specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling
and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for
membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a
separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental
implant system. These instruments require a separate technical file.
[5]
NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 .
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary

ISO 10451:2026(en)
ISO 3950, Dentistry — Designation system for teeth and areas of the oral cavity
ISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 10271, Dentistry — Corrosion test methods for metallic materials
ISO 10993-1, Biological evaluation of medical devices — Part 1: Requirements and general principles for the
evaluation of biological safety within a risk management process
ISO 10993-17, Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical
device constituents
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming,
sealing and assembly processes
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by
particle concentration
ISO 14801, Dentistry — Implants — Dynamic loading test for endosseous dental implants
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information to be
supplied — Part 2: Symbol development, selection and validation
ISO 16443, Dentistry — Vocabulary for dental implants systems and related procedure
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17665, Sterilization of health care products — Moist heat — Requirements for the development, validation
and routine control of a sterilization process for medical devices
ISO 20417, Medical devices — Information to be supplied by the manufacturer
ISO 22683, Dentistry — Rotational adaptability test between implant body and implant abutment in dental
implant systems
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices

ISO 10451:2026(en)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3950, ISO 16443,
ISO 13485 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and
performance of the device when used as intended by the manufacturer
[SOURCE: ISO 13485:2016, 3.3]
3.2
dental implant assembly
assembly of dental implant components as recommended by the manufacturer to serve the purposes of a
dental implant
[SOURCE: ISO 16443:2014, 3.2.3]
3.3
implant component coating
layer of material, different from the constitutive material of the implant component, used to cover or
partially cover a defined surface of an implant body or an implant component
[SOURCE: ISO 1942:2020, 3.7.2.7]
3.4
technical documentation
manufacturer's set of data showing conformity of a device to a list of requirements of this document and
which is intended to be used as part of the technical documentation required for conformity assessment
procedures performed by conformity assessment bodies (3.2)
Note 1 to entry: See Reference [6] for an explanation of the term “conformity assessment body”.
Note 2 to entry: In Europe, notified bodies are considered as being conformity assessment bodies and every member
state has a national regulatory authority (e.g. Zentralstelle der Länder für Gesundheitsschutz for Germany, Agence
Nationale de Sécurité du Médicament et des Produits de Santé for France). In the United States, the Food and Drug
Agency is both a regulatory authority and a conformity assessment body.
3.5
subtractive surface treatment
process that modifies a component’s surface by subtraction of material
EXAMPLE Sandblasting and acid etching are considered subtractive surface treatments.
4 Technical file content and requirements
4.1 General
The technical file should be kept up-to-date and kept for a defined period after the last device has been
placed on t
...