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SRPS EN ISO 10993-1:2008

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

Feb 27, 2008
Feb 27, 2008
95.99   Withdrawal of Standard   Jul 31, 2014

General information

95.99     Jul 31, 2014

ISS

Z076

European Norm

11.100     11.100.20  

Serbian  

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Scope

ISO 10993-1:2003 describes
the general principles governing the biological evaluation of medical devices;the categorization of devices based on the nature and duration of their contact with the body;the selection of appropriate tests.
It 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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Life cycle

NOW

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SRPS EN ISO 10993-1:2008
95.99 Withdrawal of Standard
Jul 31, 2014

REVISED BY

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SRPS EN ISO 10993-1:2014

Related project

Adopted from EN ISO 10993-1:2003

Adopted from ISO 10993-1:2003 IDENTICAL