SIST EN ISO 16409:2017 PDF

Name: SIST EN ISO 16409:2017 — Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016)
SKU: SIST EN ISO 16409:2017
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Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016)

Название (английский):

SIST EN ISO 16409:2017

Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 11 января 2017 г.
ICS:: 71.100.70
Технический комитет:: VAZ - Healthcare

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Описание (английский):

ISO 16409:2016 specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturer's instructions for use and labelling of the packaging. Excluded are interdental brushes with a plastic core. ISO 16409:2016 is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings and to interdental cleaners that do not include filaments.

Abstract

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Упомянутые в описании и другие стандарты SIST

Overview

EN ISO 16409:2016 - Dentistry - Oral care products - Manual interdental brushes (ISO 16409:2016) is a CEN-adopted international standard that defines performance requirements and test methods for hand‑powered interdental brushes with a round brush‑head cross‑section and a wired stem with inserted filaments. The standard covers product classification, test procedures, required accompanying information (instructions for use and labelling) and packaging requirements. It excludes interdental brushes with a plastic core and is not applicable to powered interdental brushes, manual toothbrushes, dental floss/tape/string or filament‑free interdental cleaners.

Key topics and technical requirements

Scope & exclusions: Applies to manual interdental brushes with wired stems and filaments; excludes plastic‑core and powered devices.

Classification: Three product types - replacement heads for handles (Type 1), permanently affixed brush heads (Type 2), and stems that function as handles (Type 3).

Brush size: Brush size is indexed by the passage hole diameter (minimum hole a brush head can pass through). Table 1 in the standard defines brush‑size ranges.

Performance tests (Clause 7): Standardised test methods include visual inspection, passage hole diameter measurement, filament retention, stem retention force, and stem durability. The document specifies sampling and pass/fail criteria for these tests.

Sampling: The revised edition specifies the number of test samples to be used in evaluation.

Accompanying information: Manufacturer’s instructions for use, required labelling on the package, and packaging requirements to ensure product safety and correct user guidance.

Applications and who uses it

Manufacturers of interdental brushes use EN ISO 16409:2016 to design, validate and quality‑control products so they meet recognised performance and safety criteria.

Test laboratories and quality assurance teams apply the standard test methods to verify filament retention, stem durability, and size conformity.

Regulatory and procurement bodies use the standard as a benchmark for product acceptance and market conformity in CEN member countries.

Dental professionals and hygiene product specifiers rely on the standard to select suitable interdental brushes for clinical recommendations and patient guidance.

Related standards

ISO 1942 (Dentistry - Vocabulary) is normatively referenced for terminology.

Adopted by CEN as EN ISO 16409:2016 for harmonised use across European national standards bodies.

Keywords: EN ISO 16409:2016, manual interdental brushes, interdental brush, oral care products, dentistry standard, test methods, brush size, filament retention, stem durability, labelling.

SIST EN ISO 16409:2017 PDF

Abstract

Похожие стандарты

SIST EN ISO 16409:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

ISO 16409:2016

Dentistry — Oral care products — Manual interdental brushes

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