Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Historical

ANSI/AAMI/ISO 10993-11:2017

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

This document 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


Content Provider
Association for the Advancement of Medical Instrumentation [aami]


Others Also Bought

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from ...
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS