ISO 3107:2022 PDF

Name: ISO 3107:2022 — Dentistry — Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
SKU: ISO 3107:2022
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Dentistry — Zinc oxide-eugenol cements and non-eugenol zinc oxide cements

Название (английский):

ISO 3107:2022

Dentistry — Zinc oxide-eugenol cements and non-eugenol zinc oxide cements

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 15 сентября 2022 г.
Издание:: ISO IS 3107 edition 5 version 1
ICS:: 11.060.10

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Описание (английский):

This document specifies requirements for zinc oxide-eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations. This document also specifies requirements for non-eugenol zinc oxide cements containing zinc oxide and oil(s) other than eugenol for temporary cementation.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 3107:2022 - Dentistry - Zinc oxide‑eugenol cements and non‑eugenol zinc oxide cements specifies performance, test methods and labelling for zinc‑oxide based cements used in restorative dentistry. The standard covers cements intended for temporary cementation, for use as bases and as temporary restorations, and also addresses non‑eugenol variants that use oils other than eugenol.

Key topics and technical requirements

Classification

Type I: for temporary cementation
Type II: for bases and temporary restorations

Performance limits (selected highlights from Table 1)

Setting time (at 37 °C): 1.5 to 10 min (both types)
Compressive strength: Type I ≥ 35 MPa; Type II ≥ 5 MPa
Film thickness: Type I ≤ 25 µm (Type II not applicable)
Acid‑soluble arsenic (24 h): ≤ 2 mg/kg

Test methods and specimen preparation

Ambient conditions for preparation: (23 ± 2) °C, 50 ± 5% RH
Setting‑time determination: specimens conditioned at 37 ± 1 °C, with specified indenters (Type I: 100 g, 2.0 mm flat end; Type II: 400 g, 1.0 mm flat end)
Compressive strength specimens: cylindrical moulds 6 mm height × 4 mm diameter, cured and stored in water before testing; mechanical tester speed and loading rates are defined in Clause 7
Film‑thickness and arsenic (acid‑soluble fraction) test procedures are specified

Biocompatibility guidance: refer to ISO 10993‑1 and ISO 7405

Labelling and packaging: requirements for marking, instructions for use and retail packaging are included

Applications and practical value

Ensures consistent performance and safety of temporary dental cements used by clinicians during:

provisional cementation of indirect restorations
temporary restorations and cavity bases

Enables manufacturers to design, test and certify zinc‑oxide eugenol and non‑eugenol formulations to meet reproducible limits for setting behavior, strength, film thickness and contaminant control.

Used by test laboratories, quality assurance teams, procurement and regulatory reviewers to verify compliance and to support product claims.

Related standards

ISO 10993‑1 (biocompatibility)

ISO 7405 (dental materials - evaluation)

ISO 1942, ISO 2590, ISO 3696, ISO 8601‑1 (referenced for terminology, arsenic testing, water quality and date/time formats)

Keywords: ISO 3107:2022, zinc oxide‑eugenol cements, non‑eugenol zinc oxide cements, temporary cementation, restorative dentistry, setting time, compressive strength, film thickness, dental standard.

ISO 3107:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and practical value

Who should use ISO 3107:2022

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)

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.

BS EN ISO 25901-2:2022

Welding and allied processes. Vocabulary. Health and safety.

SIST EN ISO 3696:1998

Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)

ISO 8601-1:2019/Amd 1:2022

Date and time — Representations for information interchange — Part 1: Basic rules — Amendment 1: Technical co…