DS/ISO 10993-1:2018

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO/FDIS 10993-1:2018)

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This part document describes:
– the general principles governing the biological evaluation of medical devices within a risk
management process;
– the general categorization of devices based on the nature and duration of their contact with the body;
– the evaluation of existing relevant data from all sources;
– the identification of gaps in the available data set on the basis of a risk analysis;
– the identification of additional data sets necessary to analyse the biological safety of the medical
– the assessment of the biological safety of the medical device.
This part document applies to evaluation of materials and devices that are expected to have direct
or indirect contact with the patient’s body during intended use. In addition, this document applies to
medical devices that are expected to have direct or indirect contact with the clinician’s body, if the
device is intended to protect the clinician (e.g., surgical gloves, masks and others). This document
is applicable to biological evaluation of all types of medical devices including active, non-active,
implantable and non-implantable medical devices.
Biological hazards arising from other risks, such as mechanical failures or changes to the device over
time, should be considered as a part of the overall biological safety assessment, and can be addressed
by relevant biocompatibility, mechanical or other in vivo animal testing or other information. Other
parts of ISO 10993 cover specific aspects of biological assessments and related tests.

Number of pages: 50

Published: 2020-12-22

Date of approval: 2020-12-21

International relationships : ISO 10993-1:2018 IDT

ICS: 11.100.20 - Biological evaluation of medical devices

Item number: M342624



  • ISO/TC 194
  • ISO/TC 194/WG 1

Danish committee