SIST EN ISO 3630-1:2019 PDF

Name: SIST EN ISO 3630-1:2019 — Dentistry - Endodontic instruments - Part 1: General requirements (ISO 3630-1:2019)
SKU: SIST EN ISO 3630-1:2019
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Dentistry - Endodontic instruments - Part 1: General requirements (ISO 3630-1:2019)

Название (английский):

SIST EN ISO 3630-1:2019

Dentistry - Endodontic instruments - Part 1: General requirements (ISO 3630-1:2019)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 29
Дата публикации:: 13 ноября 2019 г.
ICS:: 11.060.25
Технический комитет:: VAZ - Healthcare

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Описание (английский):

This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 3630-1:2019 - "Dentistry - Endodontic instruments - Part 1: General requirements" (ISO 3630-1:2019) is a CEN-adopted international standard that defines general requirements and test methods for endodontic instruments. It covers a broad range of tools used in endodontics (e.g., enlargers, compactors, shaping and cleaning instruments, accessory instruments), and establishes a numeric coding system, size designations, colour-coding, packaging, and identification symbols. This edition supersedes EN ISO 3630-1:2008 and is intended for manufacturers, test laboratories, regulatory authorities and dental professionals involved in device specification and quality assurance.

Key Topics

Scope and classification of endodontic instrument types (standard, taper, non-taper, non-uniform taper, shape instruments).

Dimensional requirements such as length, tip shape and tip length, size/diameter designation, and handle/shank dimensions.

Taper designation and calculation, including colour and ring identification for fast, unambiguous recognition.

Colour-coding and numeric coding system for diameters and tapers to standardize identification across products.

Material and mechanical requirements, including:

Resistance to fracture by twisting and angular deflection
Stiffness (resistance to bending)
Handle and shank security

Reprocessing and packaging requirements addressing sterilization and labeling needs.

Sampling, measurement and test methods, including visual inspection, dimensional measurement protocols and specific test procedures for mechanical performance.

Symbols and identification for safe, compliant product labeling.

Applications

Manufacturers and product designers - to design and label endodontic instruments that meet international dimensional and safety criteria.

Quality assurance and testing laboratories - to verify mechanical properties, dimensions, color-coding and packaging conformity using the prescribed test methods.

Regulatory and procurement teams - to specify compliant products for market clearance and purchasing.

Dental clinics and educators - to understand standardized sizing, color-coding and safe reprocessing instructions for clinical practice.

Notified bodies and auditors - to assess conformity with harmonized European (EN) and ISO requirements.

Related standards

ISO 3630 series (other parts) and national implementations (EN ISO 3630-1:2019) provide complementary, product-specific or procedural guidance. Consult the ISO and CEN catalogs for associated parts and normative references related to endodontic instruments.

Keywords: EN ISO 3630-1:2019, endodontic instruments, endodontics, dental instruments, ISO 3630-1, size designation, colour-coding, taper, test methods, reprocessing, mechanical requirements.

SIST EN ISO 3630-1:2019 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related standards

Технические детали

ISO 3630-1:2019

Dentistry — Endodontic instruments — Part 1: General requirements

ISO 3630-1:2008

Dentistry — Root-canal instruments — Part 1: General requirements and test methods

BS EN ISO 3630-3:2021

Dentistry. Endodontic instruments. Compactors.