EN ISO 23445:2021 PDF

Name: EN ISO 23445:2021 — Dentistry - Tissue punches (ISO 23445:2021)
SKU: EN ISO 23445:2021
Price: 60.09 EUR
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Dentistry - Tissue punches (ISO 23445:2021)

Название (английский):

EN ISO 23445:2021

Dentistry - Tissue punches (ISO 23445:2021)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 19 мая 2021 г.
Издание:: CEN EN 23445 edition 1 version 1
ICS:: 11.060.25

Тип поставки:

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Язык документа:

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Срок поставки:3 раб. дн. (перевод)

Цена:195 €

Описание (английский):

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.

Abstract

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

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.

Технические детали

Технический комитет: CEN/TC 55 - Dentistry
SKU: EN ISO 23445:2021

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Каталог

ISO 23445:2021

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EN ISO 23445:2021 PDF

Abstract

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

Похожие стандарты

Key topics and technical requirements

Practical applications and intended users

Related standards

Технические детали

ISO 23445:2021

Dentistry — Tissue punches

SIST EN ISO 21850-1:2020

Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)

BS ISO 17972-1:2015

Graphic technology. Colour data exchange format. Relationship to CxF3 (CxF/X).

SIST EN ISO 6507-1:2023

Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2023)

SIST EN ISO 6508-1:2024

Metallic materials - Rockwell hardness test - Part 1: Test method (ISO 6508-1:2023)

SIST EN ISO 17664-2:2024

Processing of health care products - Information to be provided by the medical device manufacturer for the pr…

SIST EN ISO 8325:2023

Dentistry - Test methods for rotary instruments (ISO 8325:2023)

SIST EN ISO 16443:2014

Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)