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SSH EN ISO 10993-11:1995

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

Jan 1, 2000
95.99 Withdrawal of Standard   Dec 16, 2008

General information

95.99     Dec 16, 2008

DPS

DPS/KT 205

European Norm

11.040.01     11.100     11.120.01  

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SSH EN ISO 10993-11:1995 :: EN

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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 directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SSH EN ISO 10993-11:1995
95.99 Withdrawal of Standard
Dec 16, 2008

REVISED BY

WITHDRAWN
SSH EN ISO 10993-11:2006

Related project

Adopted from EN ISO 10993-11:1995