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UNE-EN ISO 10993-13:2010

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

11-17-2010

1 Scope
2 Normative references
3 Definitions
4 Degradation test methods
    4.1 General procedures
    4.2 Accelerated degradation test
    4.3 Real-time degradation test
5 Test procedures
    5.1 Initial material characterization
    5.2 Accelerated degradation test
    5.3 Real-time degradation test
6 Test report
Annex A Analytical methods

This part of ISO 10993 provides 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
CTN 111
DocumentType
Standard
Pages
26
PublisherName
Asociacion Espanola de Normalizacion
Status
Current
Supersedes

ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO 14971:2007 Medical devices Application of risk management to medical devices

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