SIST EN ISO 23445:2021

Dentistry - Tissue punches (ISO 23445:2021)

This document specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures, such as cutting holes or notches in and removing of gingival tissue. It also specifies the requirements for their marking and labelling.

Zahnheilkunde - Gewebestanzen (ISO 23445:2021)

Dieses Dokument beschreibt Anforderungen und dazugehörige Prüfverfahren für Gewebestanzen, die mit einem Handstück in der Zahnheilkunde verwendet werden, besonders für oralchirurgische Implantationsverfahren wie zum Stanzen von Löchern oder Kerben im und zum Entfernen von Gingivagewebe. Es legt auch die Anforderungen an die Markierung und Kennzeichnung fest.

Médecine bucco-dentaire - Bistouris circulaires (ISO 23445:2021)

Le présent document spécifie les exigences et les méthodes d’essai afférentes aux bistouris circulaires utilisés avec une pièce à main en médecine bucco-dentaire, en particulier pour les techniques de chirurgie buccale en implantologie dentaire, pour réaliser des trous ou des incisions dans le tissu gingival et pour retirer du tissu gingival. Il spécifie également les exigences relatives à leur marquage et étiquetage.

Zobozdravstvo - Instrumenti za posege v tkivo (ISO 23445:2021)

General Information

• Status: Published
• Public Enquiry End Date: 19-Jun-2020
• Publication Date: 29-Jun-2021
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 11-Jun-2021
• Due Date: 16-Aug-2021
• Completion Date: 30-Jun-2021
• Ref Project: EN ISO 23445:2021 - Dentistry - Tissue punches (ISO 23445:2021)

EN ISO 23445:2021 - Dentistry - Tissue punches (overview)

EN ISO 23445:2021 specifies requirements and test methods for tissue punches used with a handpiece in dentistry, primarily for oral surgical implant procedures (cutting holes/notches in and removing gingival tissue). The standard covers design classification, material selection, dimensional tolerances, mechanical performance (hardness, run‑out), resistance to reprocessing, and marking, labelling and instructions for use.

Key topics and technical requirements

• Scope and use: Applies to tissue punches used with angled dental handpieces for implant-related soft‑tissue removal.
• Classification:
  • Type 1 - Hollow (simple hollow punch)
  • Type 2 - Centre‑guided (includes centre‑guide feature)
• Materials and surface: Metals shall conform to ISO 21850‑1 (stainless steel materials). Surface finish is at manufacturer’s discretion but must be free of visible surface defects on visual inspection.
• Dimensional tolerances:
  • Inner diameter (working part) and centre‑guide diameter: ±0.1 mm of manufacturer’s stated value.
  • Length of working part: ±0.5 mm.
  • Shank dimensions: conform to ISO 1797.
• Mechanical performance:
  • Hardness: ≥ 400 HV2 or ≥41 HRC (tested per ISO 6507‑1 or ISO 6508‑1).
  • Run‑out: total indicated run‑out ≤ 0.1 mm (measured with comparator 1 mm from tip).
• Resistance to reprocessing: Subject to reprocessing cycles (default 100 cycles using manufacturer’s cleaning/disinfection/sterilization per ISO 17664). No deterioration, corrosion or loss of marking permitted; hardness and run‑out rechecked after cycles.
• Inspection and test methods: Visual inspection without magnification; dimensional checks per ISO 8325; hardness and run‑out per referenced ISO test methods.
• Marking and labelling: Requirements for device marking, package labelling and user instructions, including declared dimensions and reprocessing information.

Practical applications and intended users

• Manufacturers of dental instruments and tissue punches - for product design, quality control and compliance.
• Dental implant clinicians and surgical teams - to understand instrument specifications and safe reuse limits.
• Regulatory and procurement teams - for specification, conformity assessment and purchasing of compliant devices.
• Test laboratories and quality assurance - to perform dimensional, hardness, run‑out and reprocessing evaluations.

Related standards

• ISO 1797 (shanks for rotary/oscillating instruments)
• ISO 8325 (test methods for rotary instruments)
• ISO 17664 (processing information for medical device reprocessing)
• ISO 21850‑1 (materials for dental instruments - stainless steel)
• ISO 6507‑1, ISO 6508‑1 (Vickers/Rockwell hardness tests)
• ISO 16443, ISO 1942 (vocabulary and implant-related terms)

EN ISO 23445:2021 is essential for anyone specifying, producing or testing tissue punches used in dental implantology, ensuring consistent safety, performance and reprocessing resilience.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Zobozdravstvo - Instrumenti za posege v tkivo (ISO 23445:2021)
Dentistry - Tissue punches (ISO 23445:2021)
Zahnheilkunde - Gewebestanzen (ISO 23445:2021)
Médecine bucco-dentaire - Bistouris circulaires (ISO 23445:2021)
Ta slovenski standard je istoveten z: EN ISO 23445:2021
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23445
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2021
EUROPÄISCHE NORM
ICS 11.060.25
English Version
Dentistry - Tissue punches (ISO 23445:2021)
Médecine bucco-dentaire - Bistouris circulaires (ISO Zahnheilkunde - Gewebestanzen (ISO 23445:2021)
23445:2021)
This European Standard was approved by CEN on 2 May 2021.

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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23445:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23445:2021) 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 November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
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.
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 23445:2021 has been approved by CEN as EN ISO 23445:2021 without any modification.

INTERNATIONAL ISO
STANDARD 23445
First edition
2021-04
Dentistry — Tissue punches
Médecine bucco-dentaire — Bistouris circulaires
Reference number
ISO 23445:2021(E)
©
ISO 2021
ISO 23445:2021(E)
© ISO 2021
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.
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Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 23445:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 2
5 Classification . 2
6 Requirements . 3
6.1 Selection of metals . 3
6.2 Surface finish . 3
6.3 Dimensions . 3
6.3.1 Diameter of the working part and centre-guide . 3
6.3.2 Length of the working part . 3
6.3.3 Overall length . . 3
6.3.4 Dimensions of the shank . 3
6.4 Resistance to reprocessing . 4
6.5 Hardness . 4
6.6 Run-out . 4
7 Measurement and test methods . 4
7.1 Visual inspection . 4
7.2 Dimensions . 4
7.3 Resistance to reprocessing . 4
7.4 Hardness . 4
7.5 Run-out . 4
8 Marking, labelling and instructions for use . 5
8.1 Marking on the tissue punch . 5
8.2 Labelling on the package .
...