ISO/TS 20993:2006

TECHNICAL ISO/TS
SPECIFICATION 20993
First edition
2006-08-01

Biological evaluation of medical
devices — Guidance on a risk-
management process
Évaluation biologique des dispositifs médicaux — Directives relatives
à un processus d'évaluation du risque




Reference number
ISO/TS 20993:2006(E)
©
ISO 2006

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ISO/TS 20993:2006(E)
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ISO/TS 20993:2006(E)
Foreword
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⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
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ISO/TS 20993 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
© ISO 2006 – All rights reserved iii

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ISO/TS 20993:2006(E)
Introduction
Risk management challenges the manufacturer to evaluate known and theoretical biological risks of the
product, to develop the most appropriate methods for reducing the biological risks and to implement the
appropriate test and analysis methods to demonstrate that the risks have been reduced. Material selection
and evaluation of biological risk are integral components of the concept development and design processes
for medical devices. This evaluation should be executed in line with the ISO 10993 series as a component of
the risk management plan required in ISO 14971. This process encompasses identification of device and
material hazards and the estimation and control of their associated risks.

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TECHNICAL SPECIFICATION ISO/TS 20993:2006(E)

Biological evaluation of medical devices — Guidance on a risk-
management process
1 Scope
This Technical Specification describes a process by which a manufacturer can identify the biological hazards
associated with medical devices, estimate and evaluate the risks, control these risks and monitor the
effectiveness of the control.
2 Risk management process
The evaluation of the biological safety of a medical device should be a strategy planned on a case-by-case
basis to identify the hazards and better estimate the risks of known hazards. Information from various sources
can be used in the performance of a biological risk assessment to identify areas of concern to be addressed
by, in order of priority: literature review, clinical experience or testing. The risks posed by the identified
biological hazards shall be evaluated. Testing strategy shall include a rationale for the selection and/or the
waiving of tests. The rationale should be a clear, concise, logical and scientifically reasoned plan for
evaluating biological safety, which demonstrates that biological hazards have been considered and relevant
risks assessed and controlled.
Based on the risk management process described in ISO 14971, the biological evaluation of medical devices
and their materials comprises the following elements.
a) Risk analysis:
1) intended use/device characteristics;
2) defining each material/device and its use;
3) physically and chemically characterizing each material/d
...