SIST EN ISO 19490:2025

Dentistry - Sinus membrane elevator (ISO 19490:2025)

This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.

Zahnheilkunde - Sinusmembranelevator (ISO 19490:2025)

Dieses Dokument legt Anforderungen und die dazugehörigen Prüfverfahren für Sinusmembranelevatoren, die während der Platzierung von Dentalimplantaten zur Sinusbodenanhebung verwendet werden, fest. Es beschreibt auch die Anforderungen an ihre Markierung und Kennzeichnung.

Médecine bucco-dentaire - Élévateur de membrane sinusienne (ISO 19490:2025)

Le présent document spécifie les exigences et les méthodes d’essai relatives aux élévateurs de membrane sinusienne utilisés en implantologie dentaire pour relever le plancher sinusien. Il spécifie également les exigences relatives à leur marquage et étiquetage.

Zobozdravstvo - Sinusno membransko dvigalo (ISO 19490:2025)

Ta dokument določa zahteve in njihove preskusne metode za sinusna membranska dvigala, ki se uporabljajo pri nameščanju zobnih vsadkov za dvig sinusnega dna. Določa tudi zahteve za označevanje in etiketiranje.

General Information

• Status: Published
• Public Enquiry End Date: 29-Sep-2024
• Publication Date: 24-Sep-2025
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Aug-2025
• Due Date: 19-Oct-2025
• Completion Date: 25-Sep-2025
• Ref Project: EN ISO 19490:2025 - Dentistry - Sinus membrane elevator (ISO 19490:2025)

Relations

• Replaces: SIST EN ISO 19490:2017 - Dentistry - Sinus membrane elevator (ISO 19490:2017)
• Effective Date: 19-Oct-2022

Overview

SIST EN ISO 19490:2025 is the latest European and international standard specifically addressing sinus membrane elevators used in dentistry. This standard, published by CEN and aligned with ISO, defines precise requirements, test methods, and specifications for the design, performance, marking, labelling, and safe use of these dental instruments during sinus floor lifting procedures for dental implant placement. It supersedes the earlier edition EN ISO 19490:2017, reflecting technological and procedural updates to improve clinical outcomes and ensure patient safety.

Sinus membrane elevators are handheld tools designed to gently lift or displace the sinus membrane, facilitating vertical bone augmentation necessary for secure implant insertion in the maxillary sinus area. This standard supports manufacturers, dental professionals, and regulatory bodies by harmonizing quality benchmarks across Europe and internationally.

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Key Topics

• Scope & Application
  SIST EN ISO 19490:2025 applies exclusively to sinus membrane elevators used during dental implant surgeries for sinus floor elevation. It covers both lateral (external) and vertical (crestal) approaches.

• Classification

  • Type 1: Elevators for lateral/vestibular/external approach
  • Type 2: Elevators for vertical/crestal/internal approach

• Material and Construction Requirements

  • Compliance with ISO 4865-1:2023 standards for materials, handles, surface finish, and instrument dimensions
  • Minimum hardness of the working part at 480 HV1 or 48 HRC ensures durability and safety
  • Strong connection between shank and handle with resistance to tensile forces ≥ 1000 N and torque forces ≥ 500 N·cm

• Resistance to Reprocessing
  Instruments must withstand repeated sterilization and cleaning cycles without deformation or corrosion, guaranteeing longevity and maintaining hygiene standards.

• Marking, Labelling, and Packaging
  Fully compliant with ISO 4865-1:2023, including clear identification details and safe packaging to prevent contamination or damage.

• Instructions for Use
  Detailed guidelines aligned with ISO 4865-1 and ISO 17664-1 for cleaning, disinfection, sterilization, and handling to ensure safe clinical application and effective reprocessing.

• Test Methods
  All performance and quality assessments adhere to ISO 4865-1 standardized test methods, assuring consistent evaluation criteria worldwide.

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Applications

SIST EN ISO 19490:2025 sinus membrane elevators are essential in dental implantology, specifically for procedures involving sinus floor elevation where vertical bone augmentation is required. This includes:

• Surgical preparation of the maxillary sinus floor to allow implant placement in patients with insufficient bone height.
• Use in both lateral and crestal sinus lifting techniques, adapting to different anatomical and clinical scenarios.
• Utilization by oral surgeons, periodontists, and implantologists aiming to enhance implant stability and long-term success rates.
• Ensuring instrument reliability and patient safety through materials and manufacturing standards that resist wear, corrosion, and mechanical stress.

By adhering to this standard, dental practices can improve procedural outcomes, minimize complications related to sinus membrane perforation, and maintain compliance with regulatory requirements for medical devices.

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Related Standards

• ISO 4865-1:2023 – Dentistry - General requirements of hand instruments (Part 1: Non-hinged hand instruments). Provides foundational specifications referenced extensively for the design, testing, and reprocessing of sinus membrane elevators.

• ISO 13504 – Dentistry - Requirements for instruments related to dental implant placement and treatment. Supports device compatibility and safety guidelines.

• ISO 16443 – Vocabulary for dental implant systems and procedures. Standardizes terminology relevant to implant-associated instruments.

• ISO 17664-1 – Processing of healthcare products - Instructions for manufacturer-provided cleaning, disinfection, sterilization, and packaging methods for critical and semi-critical medical devices, essential for ensuring infection control.

• ISO 1942 – Dentistry - Vocabulary. Clarifies terms used within the standard to maintain clear and uniform communication among professionals.

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Compliance with SIST EN ISO 19490:2025 ensures that sinus membrane elevators meet stringent quality and safety requirements, supporting dental professionals in delivering optimal implant procedures and enhancing patient care in maxillary sinus augmentation. This standard is a key resource for manufacturers, clinicians, and regulatory auditors in the dental instrumentation field.

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2025
Nadomešča:
SIST EN ISO 19490:2017
Zobozdravstvo - Sinusno membransko dvigalo (ISO 19490:2025)
Dentistry - Sinus membrane elevator (ISO 19490:2025)
Zahnheilkunde - Sinusmembranelevator (ISO 19490:2025)
Médecine bucco-dentaire - Élévateur de membrane sinusienne (ISO 19490:2025)
Ta slovenski standard je istoveten z: EN ISO 19490:2025
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 19490
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.060.25 Supersedes EN ISO 19490:2017
English Version
Dentistry - Sinus membrane elevator (ISO 19490:2025)
Médecine bucco-dentaire - Élévateur de membrane Zahnheilkunde - Sinusmembranelevator (ISO
sinusienne (ISO 19490:2025) 19490:2025)
This European Standard was approved by CEN on 12 July 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19490:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 19490:2025) 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 February 2026, and conflicting national standards
shall be withdrawn at the latest by February 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 19490:2017.
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 19490:2025 has been approved by CEN as EN ISO 19490:2025 without any modification.

International
Standard
ISO 19490
Second edition
Dentistry — Sinus membrane
2025-07
elevator
Médecine bucco-dentaire — Élévateur de membrane sinusienne
Reference number
ISO 19490:2025(en) © ISO 2025
ISO 19490:2025(en)
© ISO 2025
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 19490:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General .2
5.2 Resistance to reprocessing .2
5.3 Hardness of the working part .2
5.4 Connection of shank and handle .2
5.5 Shape of working part .2
6 Test method . 4
7 Marking, labelling and packaging . 4
8 Instruction for use . 4

iii
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