SIST EN ISO 10993-10:2023 PDF

Name: SIST EN ISO 10993-10:2023 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
SKU: SIST EN ISO 10993-10:2023
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Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Название (английский):

SIST EN ISO 10993-10:2023

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 60
Дата публикации:: 13 апреля 2023 г.
ICS:: 11.100.20
Технический комитет:: VAZ - Healthcare

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Описание (английский):

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: — details of in vivo skin sensitization test procedures; — key factors for the interpretation of the results. NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 10993-10:2023 (ISO 10993-10:2021) - Biological evaluation of medical devices - Part 10: Tests for skin sensitization - specifies procedures for assessing whether medical devices or their constituent materials can induce skin sensitization. The standard focuses on in vivo test methods and key factors for interpreting results, with instructions for material preparation provided in Annex A. It is part of the ISO 10993 series used for biocompatibility and supports conformity to EU regulatory requirements (Regulation (EU) 2017/745) when applied with related parts of the series.

Key topics

Scope and step-wise approach: A risk-based, progressive testing strategy to determine need and type of skin sensitization testing.

Pretest considerations: Guidance on information collection (chemical composition, existing data), and material-specific issues for ceramics, metals and alloys, polymers, and biologically derived materials.

In vivo test methods:

Murine Local Lymph Node Assay (LLNA) - principle, sample preparation, animals and husbandry, test procedure, treatment groups, measurement of lymph node cellular proliferation, data interpretation and reporting.
Guinea pig assays - principles, induction and challenge phases, selection of test concentrations and interpretation.

Important variables: Material preparation, sample extraction, concentration selection, animal welfare and husbandry, and analytical endpoints that affect test outcomes.

Reporting and interpretation: Criteria for results, documentation requirements and how to integrate findings into biological evaluation and risk management.

Regulatory alignment: Annex ZA explains how EN ISO 10993-10 aligns with General Safety and Performance Requirements of the EU Medical Device Regulation (MDR).

Applications

Medical device manufacturers conducting biocompatibility testing and safety evaluations.

Contract testing laboratories performing skin sensitization tests (LLNA and guinea pig assays).

Regulatory affairs and quality teams preparing technical documentation and addressing EU MDR requirements.

Notified bodies and clinical safety assessors reviewing device safety and risk management files.

R&D teams selecting materials and designing preclinical safety strategies.

Practical uses:

Determining whether device materials or residuals pose a sensitization risk.

Designing test plans, preparing samples (per Annex A), and interpreting in vivo assay results.

Supporting premarket submissions and post-market safety assessments.

Related standards

ISO 10993-1: Biological evaluation - Part 1: Evaluation and testing within a risk management process (EN ISO 10993-1:2020)

ISO 10993-2: Animal welfare requirements (EN ISO 10993-2:2006)

ISO 10993-12: Sample preparation and reference materials (EN ISO 10993-12:2021)

ISO 10993-18: Chemical characterization of medical device materials (EN ISO 10993-18:2020)

Keywords: EN ISO 10993-10:2023, ISO 10993-10, skin sensitization, biological evaluation, medical devices, LLNA, guinea pig assay, EU MDR.

SIST EN ISO 10993-10:2023 PDF

Abstract

Похожие стандарты

Overview

Key topics

Applications

Related standards

Технические детали

ISO 10993-10:2021

Biological evaluation of medical devices — Part 10: Tests for skin sensitization

ISO 10993-2:2006

Biological evaluation of medical devices — Part 2: Animal welfare requirements

ISO 10993-12:2021

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 10993-18:2020

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials wit…

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

ISO 10993-2:2022

Biological evaluation of medical devices — Part 2: Animal welfare requirements

SIST EN ISO 10993-1:2026

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

ISO 10993-18:2020/Amd 1:2022

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials wit…