SR EN ISO 10993-11:1998

Biological evaluation of medical devices. Part 11: Tests for systemic toxicity

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.

General information

Status : Withdrawn
Approval date : 8/15/1997
Publish date : 8/16/1997
Withdrawal date : 2/12/2007
Number of pages : 22
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN 30993-3:1996
Normative reference SR EN 30993-1:1996
Normative reference SR ISO 10993-2:1996
Replaced by SR EN ISO 10993-11:2007