BS EN ISO 10993-11:2009
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)

Standard No.

BS EN ISO 10993-11:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Status

Be replaced 2018-06

Replace By

BS EN ISO 10993-11:2018

Latest

BS EN ISO 10993-11:2018(2022)

Replace

BS EN ISO 10993-11:2006

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.

BS EN ISO 10993-11:2009 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update

BS EN ISO 10993-11:2009 history

• 0000 BS EN ISO 10993-11:2018(2022)
• 2018 BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
• 2009 BS EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)
• 0000 BS EN ISO 10993-11:2006