ISO 7405:2025

Name: ISO 7405:2025 — Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
SKU: ISO 7405:2025
Price: 108000 RUB
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Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

Название (английский):

ISO 7405:2025

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 60
Дата публикации:: 20 июня 2025 г.
Издание:: ISO IS 7405 edition 4 version 1
ICS:: 11.060.10

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Full version108 000 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

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Срок поставки:10 раб. дн. (перевод)

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Описание (английский):

This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 7405:2025 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry is the ISO international standard that specifies test methods and evaluation processes for assessing the biological effects of dental medical devices. The fourth edition (2025) replaces ISO 7405:2018 and consolidates guidance on sample preparation, test selection, categorization by contact type and duration, and specific in vitro and in vivo tests. The standard covers devices and pharmacological agents that come into direct or indirect contact with the patient; it does not apply to materials/devices that never contact the patient.

Key topics and requirements

Device categorization

By nature of contact: non‑contact, surface‑contacting, external communicating, implants
By duration of contact: limited, prolonged, long‑term exposure

Biological evaluation process

Test selection, overall assessment, re‑evaluation principles
Emphasis on physical and chemical characterization prior to biological testing

Sample preparation

General recommendations and special procedures for light‑curing and chemically setting materials

Specific test methods

In vitro assays: agar diffusion test, filter diffusion test, dentine barrier cytotoxicity
In vivo/usage tests: pulp and dentine usage test, pulp capping test, endodontic usage test
Implant guidance: endosseous dental implant usage (informative annex)

Advanced/ancillary assays

Antioxidant responsive element (ARE) reporter assay for oxidative stress
Margin of Safety (MoS) assessment methodology (informative annex)

Reporting and assessment

Defined parameters for result assessment, controls, animal welfare considerations where applicable

Normative references

Updated references (e.g., replacement of ISO 6344‑1 with ISO 6344‑3)

Practical applications

Manufacturers of dental materials and devices use ISO 7405:2025 to design preclinical testing programs that demonstrate biocompatibility for regulatory submissions and product safety files.

Test laboratories apply the standard’s methods (agar/filter diffusion, dentine barrier, pulp tests) to generate reproducible cytotoxicity and usage data.

Regulatory bodies and notified bodies rely on the standard to evaluate compliance and risk assessment for marketed dental devices.

Researchers and dental clinicians consult the standard for validated approaches when assessing novel dental materials (resins, cements, implants, endodontic sealers).

Related standards

ISO 7405:2025 was prepared by ISO/TC 106 (Dentistry) in collaboration with CEN/TC 55. It references other ISO standards for test methods and characterization; consult the normative references within the document for cross‑referenced standards (e.g., updated abrasive standards like ISO 6344‑3).

ISO 7405:2025

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications

Who should use this standard

Related standards

Технические детали

ISO 7405:2018

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

ISO 6344-1:1998

Coated abrasives — Grain size analysis — Part 1: Grain size distribution test

ISO 6344-3:1998/Cor 1:1999

Coated abrasives — Grain size analysis — Part 3: Determination of grain size distribution of microgrits P240…