EN ISO 7711-1:2021 PDF

Name: EN ISO 7711-1:2021 — Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)
SKU: EN ISO 7711-1:2021
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Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)

Название (английский):

EN ISO 7711-1:2021

Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 18
Дата публикации:: 24 ноября 2021 г.
Издание:: CEN EN 7711 edition 2 version 1
ICS:: 11.060.20

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Описание (английский):

This document specifies the general requirements and test methods for diamond rotary instruments used in dentistry, including designation, colour code and grit sizes and a quality control for these instruments. It applies to all types of diamond rotary instruments independent of type and shape with exception to diamond discs, which are specified in ISO 7711-2.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 7711-1:2021 - "Dentistry - Diamond rotary instruments - Part 1: General requirements" defines the general requirements and test methods for diamond rotary instruments used in dentistry. It covers designation, colour coding, grit sizes and quality-control criteria applicable to all diamond rotary instruments (except diamond discs, which are covered in ISO 7711-2). The standard sets expectations for materials, dimensions, mechanical strength and reprocessing resistance to ensure consistent performance and safety.

Key topics and technical requirements

Scope and definitions: Clear terms for blank, shank, neck and working part; distinction between microgrit and macrogrit.

Materials and construction: Requirements for blank materials and shank hardness, and for the diamond-coated working part.

Designation and marking: Rules for designation codes, colour codes and grit size identification to aid selection and traceability.

Grit size and distribution: Requirements for grit classification (microgrit by sedimentation, macrogrit by sieving) and how grit sizes are reported.

Dimensions and tolerances: Specified nominal dimensions for overall length, shank and working part to be measured and controlled.

Mechanical testing:

Bending and breaking tests to verify instrument strength.
Run-out measurement to assess rotational accuracy and its change after bending.

Resistance to processing and reprocessing: Tests and procedures to confirm instruments withstand cleaning, disinfection and sterilization without performance loss.

Measurement and sampling methods: Defined sampling plans, dimension and run-out test procedures, and visual inspection criteria.

Marking, packaging and instructions: Mandatory marking on instruments and labelling on packaging, plus required information for safe use and reprocessing.

Applications and users

This standard is practical and relevant for:

Manufacturers - product design, production tolerances, quality control, labelling and CE/market compliance.

Quality assurance and test laboratories - sampling, mechanical and reprocessing test methods and acceptance criteria.

Dental product procurement and regulatory bodies - specification writing, conformity assessment and procurement requirements.

Dental clinicians and dental technicians - selecting appropriate burs by grit size, colour code and intended use; understanding reprocessing limits and handling instructions.

Related standards

EN ISO 7711-1 references and complements other standards, including:

EN ISO 7711-1:2021 is essential for consistent manufacture, testing and safe clinical use of dental diamond rotary instruments and improves interoperability across suppliers and users.

EN ISO 7711-1:2021 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 7711-1:2021

Dentistry — Diamond rotary instruments — Part 1: General requirements

SIST EN ISO 7711-2:2011

Dentistry - Rotary diamond instruments - Part 2: Discs (ISO 7711-2:2011)

SIST EN ISO 7711-1:2022/A1:2025

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BS ISO 17972-1:2015

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BS EN ISO 21572:2019

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SIST EN ISO 14457:2018

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SIST EN ISO 8325:2023

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ISO 6106:2005

Abrasive products — Checking the grit size of superabrasives