ISO 3630-5:2020 PDF

Name: ISO 3630-5:2020 — Dentistry — Endodontic instruments — Part 5: Shaping and cleaning instruments
SKU: ISO 3630-5:2020
Price: 25 EUR
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Dentistry — Endodontic instruments — Part 5: Shaping and cleaning instruments

Название (английский):

ISO 3630-5:2020

Dentistry — Endodontic instruments — Part 5: Shaping and cleaning instruments

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 25 августа 2020 г.
Издание:: ISO IS 3630 edition 2 version 1
ICS:: 11.060.20

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Описание (английский):

This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 3630-5:2020 - Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments specifies requirements and test methods for hand-held and mechanically operated instruments used to shape and clean root canals (instruments not covered in other parts of the ISO 3630 series). The standard covers size, marking, product designation, safety, labelling and packaging, and references general requirements in ISO 3630-1. It is essential for manufacturers, testing laboratories, regulators and clinicians involved with endodontic instruments.

Key topics and technical requirements

Scope and classification

Applies to shaping and cleaning endodontic instruments; classified into five classes per ISO 3630-1.

Materials and construction

Materials for working parts, shanks and handles are at the manufacturer’s discretion but must meet ISO 3630-1 requirements.

Dimensions

Nominal diameter, taper and lengths must comply with ISO 3630-1; tolerances for diameters of Classes 2–5 are specified.

Mechanical performance

Resistance to fracture (twisting and angular deflection) and stiffness (resistance to bending) are defined. Minimum torque and angular-deflection values and maximum bending moments are provided in tabulated form (Tables 1–6) by instrument class and nominal size.
Handle or plastic shank security must meet ISO 3630-1 requirements.

Chemical and sterilization effects

Requirements for corrosion resistance and heat effects of sterilization reference ISO 3630-1 test methods; instruments marked “For single use” and delivered sterile are excluded from some reprocessing tests.

Color-coding, marking and labelling

Colour, size marking, product designation and identification symbols must comply with the referenced clauses in ISO 3630-1.

Sampling and test acceptance

Typical sampling: test 10 similar instruments; acceptance criteria specified (all 10 pass; if 9 pass, test 10 more).

Resistance to reprocessing

Manufacturer must provide reprocessing method; test 10 instruments through the stated number of cycles (if unspecified, carry out 10 cycles) and inspect for defects.

Applications and users

Manufacturers - design, production tolerances, quality control, labelling, packaging and performance testing for endodontic shaping and cleaning instruments.

Test laboratories - perform mechanical, chemical and reprocessing tests per the standard’s methods and sampling rules.

Regulatory and procurement - set product acceptance criteria and compliance evidence for dental device approvals and purchasing.

Clinicians and dental facilities - rely on manufacturer labelling (single-use vs reusable), instructions for reprocessing, and standardized size/colour coding for safe clinical use.

Related standards

ISO 3630-1 (General requirements for endodontic instruments)

ISO 1942 (Dentistry - Vocabulary)

ISO 10993-1 and ISO 7405 (recommended references for biological/toxicological assessment)

Keywords: ISO 3630-5:2020, endodontic instruments, shaping and cleaning instruments, root canal instruments, dental instrument standards, mechanical testing, sterilization, reprocessing, device marking.

ISO 3630-5:2020 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

BS EN ISO 3630-3:2021

Dentistry. Endodontic instruments. Compactors.

SIST EN ISO 3630-1:2019

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

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 7405:2025

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)