Customer Service:
Mon - Fri: 8:30 am - 6 pm EST
Back
Standards PDF Cover Page

 Most recent

ANSI/AAMI/ISO 10993-17:2002 (R2012)

Biological evaluation of medical devices - Part 17: Methods for the establishment of allowable limits for leachable substances

Specifies the method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.

Available for Subscriptions

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

Others Also Bought

ANSI/AAMI/ISO 10993-12:2012
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
Add to cart
ANSI/AAMI/ISO 10993-10:2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Add to cart
ANSI/AAMI/ISO 10993-11:2006 (R2010)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Add to cart
Document History
Revises:
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.

Useful Links
CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS
2024 © American National Standards Institute (ANSI) All Rights Reserved.