ISO 10993-3:2014 PDF

Name: ISO 10993-3:2014 — Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
SKU: ISO 10993-3:2014
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Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Название (английский):

ISO 10993-3:2014

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 34
Дата публикации:: 24 сентября 2014 г.
Издание:: ISO IS 10993 edition 3 version 1
ICS:: 11.100.20

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Описание (английский):

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Abstract

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Стандарты, упомянутые в описании

Overview

ISO 10993-3:2014 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - provides strategies and test-selection guidance for assessing the potential of medical devices and their materials to cause genotoxicity, carcinogenicity, or reproductive/developmental toxicity. Applicable when a risk assessment indicates these hazards are relevant, the standard helps manufacturers, toxicologists and test laboratories decide what tests are necessary and how to interpret results within a device-specific risk management process.

Key technical topics and requirements

Risk-based test strategy: Testing is required only when justified by a device-specific risk assessment that considers chemical constituents, manufacturing residues, degradation products, exposure routes and clinical use.

Genotoxicity testing: Guidance on in vitro and in vivo genotoxicity assays, sample preparation and follow-up evaluation to maximize test sensitivity.

Carcinogenicity testing: Evaluation strategies for long-term studies, including considerations for implantation studies and criteria for study design.

Reproductive and developmental toxicity: Selection of appropriate reproductive toxicity tests (screening and full studies) and sample-preparation requirements.

Sample preparation: Procedures for extracts, leachables and resuspended device-related materials consistent with ISO 10993-12 to ensure relevant exposure in test systems.

Reporting and follow-up: Requirements for test reports and structured follow-up evaluation (flowchart guidance) when initial results indicate concern.

Normative and informative annexes: Practical guidance (Annex A–F) on sample prep, follow-up flowcharts, rationale for test systems, implantation study considerations and in vitro embryo toxicity tests.

Referenced test methods: Cross-references to OECD and other standard methods (e.g., OECD 471, 473, 476, 487, OECD 414/415/416/421/451/453) for validated assay protocols.

Practical applications - who uses ISO 10993-3:2014

Medical device manufacturers performing biocompatibility and safety assessments.

Regulatory affairs professionals preparing premarket submissions.

GLP-certified testing laboratories designing genotoxicity, carcinogenicity or reproductive toxicity studies.

Toxicologists and clinical safety assessors conducting device-specific risk estimation.

Notified bodies and regulatory agencies evaluating evidence for device approval.

Related standards

ISO 10993-1: Evaluation and testing within a risk management process

ISO 10993-12: Sample preparation and reference materials

ISO 10993-6, -5, -11, -18 and other parts of the ISO 10993 series for complementary biocompatibility, chemical characterization and toxicity guidance

This standard is essential when assessing irreversible biological hazards from medical devices and integrates with ISO 10993 risk management, OECD test methods and laboratory best practices for reliable genotoxicity, carcinogenicity and reproductive toxicity evaluation.

ISO 10993-3:2014 PDF

Abstract

Похожие стандарты

Overview

Key technical topics and requirements

Practical applications - who uses ISO 10993-3:2014

Related standards

Технические детали

SIST EN ISO 10993-1:2026

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of…

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

ISO 10993-6:2016

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation