ANSI/AAMI/ISO 10993-13:2010(R2019)
Current
The latest, up-to-date edition.
Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices
English
09-10-2023
This standard 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.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-396-1
|
| Pages |
28
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-13:2010 | Identical |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
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