EN ISO 13897:2018

Name: EN ISO 13897:2018 — Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)
SKU: EN ISO 13897:2018
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Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)

Название (английский):

EN ISO 13897:2018

Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 28 февраля 2018 г.
Издание:: CEN EN 13897 edition 2 version 1
ICS:: 11.060.10

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Описание (английский):

ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements. NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

Abstract

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Стандарты, упомянутые в описании

Overview

EN ISO 13897:2018 - Dentistry - Dental amalgam reusable mixing‑capsules - specifies requirements and test methods for reusable mixing‑capsules used to contain dental amalgam alloy powder and dental mercury during mechanical mixing. The document focuses on dimensional tolerances, containment performance during mixing, and residual retention of amalgam after pellet removal. It replaces the 2004 edition and narrows the scope to reusable capsules (single‑use capsule requirements are addressed in ISO 20749:2017).

Key topics and technical requirements

Dimensions

Overall length tolerance: ±1 mm of the manufacturer’s specified length.
Maximum external diameter tolerance: ±0.5 mm of the manufacturer’s specified diameter.
Sampling/acceptance: all 10 capsules in the test sample must meet dimensional tolerances.

Loss of mass during mixing

Maximum allowable loss: ≤ 0.5 mg per capsule.
Sampling/acceptance: 5/5 or 9/10 capsules in the sample must meet this requirement.

Retention of dental amalgam

Residual amalgam after pellet removal must be ≤ 1% of the combined mass of alloy powder and mercury originally inserted.
Sampling/acceptance: 5/5 or 9/10 capsules in the sample must meet this requirement.

Test methods

Detailed procedures are given in clauses 6.1 (dimensions), 6.2 (loss of mass during mixing) and 6.3 (retention of dental amalgam), including apparatus, sample preparation, test procedure, result expression and reporting.

Labelling and documentation

Requirements updated from the previous edition; manufacturers must provide appropriate labelling and instructions.

Practical applications - who uses this standard

Manufacturers of dental mixing‑capsules: to design, validate and declare conformity of reusable capsules.

Test laboratories and quality control teams: to perform the specified dimensional and performance tests (6.1–6.3) and generate compliance reports.

Dental equipment suppliers and clinics: to select compatible capsules for amalgamators and confirm safe, reliable containment during mixing.

Regulators and procurement: to reference objective acceptance criteria for product approvals and purchasing specifications.

Standards and compliance officers: to ensure products meet European/national adoption of EN ISO 13897:2018.

Related standards

ISO 7488 - Mixing machines for dental amalgam (machine requirements; capsules not covered).

ISO 20749:2017 - Requirements for single‑use pre‑capsulated dental amalgam products.

ISO 24234:2015 and ISO 1942 - Dental amalgam and terminology references used by this standard.

Keywords: EN ISO 13897:2018, dental amalgam, reusable mixing‑capsules, dentistry standard, mixing capsule test methods, loss of mass, retention, dimensional tolerances.

EN ISO 13897:2018

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards

Технические детали

ISO 13897:2018

Dentistry — Dental amalgam reusable mixing-capsules

ISO 20749:2017

Dentistry — Pre-capsulated dental amalgam

ISO 24234:2015

Dentistry — Dental amalgam

SIST EN ISO 7488:2018

Dentistry - Mixing machines for dental amalgam (ISO 7488:2018)

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.