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Norm
ÖNORM EN ISO 10993-15
Issue date: 2001 05 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and
quantifying degradation products from finished metallic medi...
Withdrawn: 2010 01 01
Publisher:
Austrian Standards International
Format:
Digital | 18 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 metallic medical devices or corresponding material samples finished
as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the
finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these
tests, the test results may not reflect the implant or material behavior in the body. The described chemical
methodologies are a means to generate degradation products for further assessments.
This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress.
NOTE Mechanically induced degradation, such as wear, may be covered in the appropriate product-specific standard.
Where product-group standards provide applicable product-specific methodologies for the identification and quantification of
degradation products, those standards should be considered.
Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are
identified for quantifying the degradation products. The identification of trace elements (< 10 ¿6) contained in the
specific metal or alloy is not addressed in this part of ISO 10993, nor are specific requirements for acceptable
levels of degradation products provided in this part of ISO 10993.
This part of ISO 10993 does not address the biological activity of the degradation products; see instead the
applicable clauses of ISO 10993-1 and ISO 10993-17.
ÖNORM EN ISO 10993-15
2023 08 15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation...
Norm
ÖNORM EN ISO 10993-15
2009 12 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation...
Norm
ÖNORM EN ISO 10993-15
2001 05 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation...
Norm
↖
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
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Issue date :
1995 08 01
Water for analytical laboratory use - Specifications and test methods (ISO 3696:1987)
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Issue date :
2009 09 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
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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)
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Issue date :
2009 09 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
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Issue date :
1999 11 01
Corrosion of metals and alloys - Basic terms and definitions (ISO 8044:1999)
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Issue date :
2009 08 15
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
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Issue date :
2009 09 15
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
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Issue date :
1987 04 09
Water for analytical laboratory use — Specification and test methods
Norm
Issue date :
1999 12 16
Corrosion of metals and alloys — Basic terms and definitions
Norm
Issue date :
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
Norm
Issue date :
1996 09 05
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
Issue date :
1998 11 19
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
1997 08 28
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Norm
Issue date :
2000 11 30
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Corrected version 2001-03)
Norm
Issue date :
2009 12 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)