DS/EN ISO 10993-1:2009 (Valid to: 30-06-2021)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Valid to: 30-06-2021
Replaced by:
Price from:
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Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:


This part of ISO 10993 describes:
a) the general principles governing the biological evaluation of medical devices within a risk managementframework;
b) the general categorization of devices based on the nature and duration of their contact with the body;
c) the evaluation of existing relevant data from all sources;d) the identification of gaps in the available data set on the basis of a risk analysis;
e) the identification of additional data sets necessary to analyze the biological safety of the medical device;
f) the assessment of the biological safety of the medical device.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword.

Number of pages: 40

Published: 2009-11-13

Date of approval: 2009-11-05

International relationships : EN ISO 10993-1:2009 IDT ISO 10993-1:2009 IDT

ICS: 11.100.20 - Biological evaluation of medical devices

Item number: M216659

*Expected revoked date: 30-06-2021



  • CEN/TC 206
  • ISO/TC 194/WG 1

Danish committee


Included in