ISO 9917-1:2025 PDF

Name: ISO 9917-1:2025 — Dentistry — Water-based cements — Part 1: Acid-base cements
SKU: ISO 9917-1:2025
Price: 25 EUR
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Dentistry — Water-based cements — Part 1: Acid-base cements

Название (английский):

ISO 9917-1:2025

Dentistry — Water-based cements — Part 1: Acid-base cements

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 29
Дата публикации:: 27 мая 2025 г.
Издание:: ISO IS 9917 edition 3 version 1
ICS:: 11.060.10

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Описание (английский):

This document specifies requirements and test methods for acid-base, dental cements intended for permanent cementation, lining and restoration. This document is not intended to address resin-modified water-based cements. This document is applicable to both hand-mixed and encapsulated cements for mechanical mixing. This document specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, base or liner, restorative material or pit and fissure sealing cement.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 9917-1:2025 - Dentistry - Water‑based cements - Part 1: Acid‑base cements specifies requirements and test methods for acid‑base, water‑based dental cements used for permanent cementation, lining and restoration. The third edition applies to both hand‑mixed and encapsulated cements intended for mechanical mixing and excludes resin‑modified water‑based and non‑acid‑base materials (e.g., calcium silicate–based cements). It defines limits and test procedures according to the intended application: luting agent, base/liner, restorative material or pit and fissure sealing cement.

Key topics and technical requirements

ISO 9917-1:2025 covers material, classification, testing and information that manufacturers and test labs must provide. Major technical topics include:

Classification by chemical type (e.g., zinc phosphate, zinc polycarboxylate, glass polyalkenoate) and by application (luting, base/liner, restorative, pit & fissure sealing).

Material requirements for powder and liquid components and for the unset mixed cement (homogeneity, absence of deposits).

Test methods and limits for properties such as:

Net setting time (separate methods for general use and pit & fissure sealing)
Film thickness (for luting cements)
Compressive strength
Acid erosion
Optical properties (polyalkenoate restorative cements)
Acid‑soluble arsenic and lead contents
Radiopacity (if the manufacturer claims it)

Sampling, preparation and ambient conditions for test specimens (23 ±1 °C; 50 ±10 % RH) and specified mixing procedures.

Packaging, marking and labelling requirements, including a declaration of components and information the manufacturer must supply.

Normative annexes (A–I) provide step‑by‑step test procedures for all referenced measurements (e.g., net setting time, film thickness, radiopacity).

Applications and users

Who uses ISO 9917-1:2025:

Dental product manufacturers - to design, test and certify acid‑base cements for specific clinical uses.

Test laboratories and quality control teams - to perform standardized measurements and compliance testing.

Regulatory bodies and conformity assessors - to evaluate product safety, labelling and performance claims.

Dental researchers and R&D - for comparative testing and material development.

Procurement and clinicians - to understand performance claims (e.g., setting time, compressive strength, radiopacity) when selecting cements.

Related standards

ISO 10993‑1 and ISO 7405 (biological/toxicological assessment recommendations)

ISO 13116 (radiopacity test method adopted)

ISO 1942 (dentistry vocabulary)

Other ISO 9917 series parts for complementary guidance

Using ISO 9917-1:2025 helps ensure consistent, testable performance of acid‑base dental cements and supports regulatory compliance, product claims and clinical reliability.

ISO 9917-1:2025 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

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)

SIST EN ISO 13116:2015

Dentistry - Test Method for Determining Radio-Opacity of Materials (ISO 13116:2014)

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.

SIST EN ISO 9917-1:2025

Dentistry - Water-based cements - Part 1: Acid-base cements (ISO 9917-1:2025)