EN ISO 10993-11:1995

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993)

Publication date:   Oct 23, 2003

General information

99.60 Withdrawal effective   Aug 15, 2006

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.040.01   Medical equipment in general | 11.100   Laboratory medicine | 11.120.01   Pharmaceutics in general

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Scope

This part of ISO 10993 specifies methodologies for the evaluation of the systematic toxicity potential of medical devices with release constituents into the body. In addition, it includes pyrogenicity testing. The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachables. It is intended that tests for extracts or leachables be conducted by choosing appropriate extraction vehicles to yield a maximum extraction of leachable materials, in order to conduct biological testing.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN ISO 10993-11:1995
99.60 Withdrawal effective
Aug 15, 2006

REVISED BY

WITHDRAWN
EN ISO 10993-11:2006

Relations

Adopted from ISO 10993-11:1993 IDENTICAL