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Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)

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Hardcopy , PDF

Language(s)

English

Published date

08-01-2026

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Dates of withdrawal of national standards are available from NSAI.

European forewordAnnex ZA (informative) Relationship between this European Standard the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered

This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971.

DocumentType	Standard
Pages	42
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 10993-1:2020&LC:2021

Standards	Relationship
EN ISO 10993-1:2025	Identical
ISO 10993-1:2025	Identical
BS EN ISO 10993-1:2025	Equivalent

ISO 22442-2:2020	Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
ISO/TS 37137-1:2021	Biological evaluation of absorbable medical devices — Part 1: General requirements
ISO 18562-1:2024	Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

Frequently Asked Questions

I.S. EN ISO 10993-1 provides requirements or test guidance for evaluating biological risks associated with patient-contacting medical devices. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 10993-1 is used by medical device manufacturers, toxicologists and laboratories planning or performing biological evaluation. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 10993-1 is National Standards Authority of Ireland (NSAI)'s standard for biological evaluation of medical devices, while I.S. EN ISO 10555-1 covers intravascular catheters (Ireland). I.S. EN ISO 10993-1 provides requirements or test guidance for evaluating biological risks associated with patient-contacting medical devices. I.S. EN ISO 10555-1 specifies general requirements and test methods for sterile, single-use intravascular catheters.

No — I.S. EN ISO 10993-1 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.

I.S. EN ISO 10993-1 provides requirements or test guidance for evaluating biological risks associated with patient-contacting medical devices. In practice it is applied by medical device manufacturers, toxicologists and laboratories planning or performing biological evaluation.

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I.S. EN ISO 10993-1:2025

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Industry

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What does I.S. EN ISO 10993-1 cover?

Who uses I.S. EN ISO 10993-1?

What is the difference between I.S. EN ISO 10993-1 and I.S. EN ISO 10555-1?

Is I.S. EN ISO 10993-1 an Australian standard?

What is I.S. EN ISO 10993-1 used for?