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

 Historical

ANSI/AAMI/ISO 10993-13-2010 (R2014)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

Available for Subscriptions

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

Others Also Bought

ANSI/AAMI/ISO 10993-16:2017
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and le ...
Add to cart
ANSI/AAMI/ISO TIR10993-20:2006
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical ...
Add to cart
ISO/TS 10993-19:2020
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization ...
Add to cart
Document History
Revises:
Revised By:
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.