DIN EN ISO 10993-13:2010 Edition

$33.80

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

Published By	Publication Date	Number of Pages
DIN	2010-11	24

Guaranteed Safe Checkout

Categories: 11.100.20 - Biological evaluation of medical devices, DIN

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

Degradation products covered by this standard are formed primarily by chemical bond scission due to hydrolytic and/or oxidative processes in an aqueous environment. It is recognized that additional biological factors, such as enzymes, other proteins and cellular activity, can alter the rate and nature of degradation. The identified and quantified degradation products form the basis for biological evaluation in accordance with ISO 10993-1, for risk assessment in accordance with ISO 10993-17 and, if appropriate, for toxicokinetic studies in accordance with ISO 10993-16.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2010-11
Pages Count	24
Language	Germany
Descriptors	Bioassay, Biological tests, CE marking, Decomposition, Decomposition products, Definitions, Degradability, Degradation, Deterioration, Evaluations, Identification, Medical devices, Medical products, Methods, Polymers, Quantification, Real-time, Screening-method, Specification (approval), Testing, Verification, Procedures, Processes
File Size	962.6 KB
ICS Codes	11.100.20 - Biological evaluation of medical devices

Preview PDF


PDF Format	Searchable	Printable	Preview Now

DIN EN ISO 10993-13:2010 Edition

Related products