ISO 10993-1:2018

ISO 10993-1:2018 provides a framework for planning the biological evaluation of medical devices within a risk management process. It specifies the general principles governing the biological evaluation of devices that come into direct or indirect contact with the body, guiding manufacturers in determining which biological tests or assessments are necessary based on device characteristics and intended use.

Overview

Background

Published by the International Organization for Standardization (ISO), this standard is the foundational document in the ISO 10993 series on biological evaluation of medical devices. The 2018 edition placed greater emphasis on using existing data and risk assessment to reduce unnecessary animal testing, while maintaining rigorous safety evaluation requirements.

Applicability

This standard applies to manufacturers of medical devices that have direct or indirect contact with the patient's body, body fluids, or tissues. It covers devices in all risk classes and guides the selection of appropriate tests from the ISO 10993 series based on the nature and duration of body contact, device material composition, and intended use.

Core Principles

Risk-based biological evaluation planning

Material characterization before testing

Categorization by body contact nature and duration

Evaluation endpoint selection and justification

Use of existing data and literature

Toxicological risk assessment approach

Biological evaluation plan and report

Re-evaluation for material or process changes