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Norm
ÖNORM EN ISO 10993-13
Issue date: 2009 09 15
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medi...
Withdrawn: 2010 10 01
Publisher:
Austrian Standards International
Format:
Digital | 21 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer.
This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation.
ÖNORM EN ISO 10993-13
2010 10 01
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation...
Norm
ÖNORM EN ISO 10993-13
2009 09 15
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation...
Norm
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ÖNORM EN ISO 10993-13
1999 05 01
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation...
Norm
Norm
Issue date :
1995 08 01
Water for analytical laboratory use - Specifications and test methods (ISO 3696:1987)
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
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1987 04 09
Water for analytical laboratory use — Specification and test methods
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1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
Issue date :
1999 03 04
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
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Issue date :
1996 09 05
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
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Issue date :
1997 08 28
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
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Issue date :
1997 01 22
Poly(L-lactide) resins and fabricated forms for surgical implants — In vitro degradation testing
Norm
Issue date :
2010 10 01
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Norm
Issue date :
1998 11 19
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
