EN ISO 10993-11:2009
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Standard No.

EN ISO 10993-11:2009

Release Date

2009

Published By

CEN - European Committee for Standardization

Status

Be replaced

Replace By

EN ISO 10993-11:2018

Latest

EN ISO 10993-11:2018

Scope

This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

EN ISO 10993-11:2009 history

• 2018 EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• 2009 EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• 2006 EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• 1995 EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)