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  • BSI
    BS EN ISO 10993-15:2009 Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys
    Edition: 2009
    $316.70
    / user per year

Description of BS EN ISO 10993-15:2009 2009

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.



Standard NumberBS EN ISO 10993-15:2009
TitleBiological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys
StatusWithdrawn
Publication Date2009-07-31
Withdrawn Date2023-05-24
ReplacesBS EN ISO 10993-15:2001
Replaced ByBS EN ISO 10993-15:2023
Identical National Standard OfISO 10993-15:2009, EN ISO 10993-15:2009
DescriptorsMedical equipment, Metals, Chemical analysis and testing, Physico-chemical methods, Medical instruments, Alloys, Biological analysis and testing, Deterioration, Accelerated corrosion tests, Degradation, Chemical reactions
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 580 68107 3
PublisherBSI
Pages22

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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