ANSI AAMI ISO 10993-15:2000 pdf download – Biological evaluation of medical devices
1.Scope
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- “) 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.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 3585, Borosilicate glass 3.3- Properties.
ISO 3696, Water for analytical laboratory use- Specification and test methods.
ISO 8044, Corrosion of metals and aloys- Basic terms and definitions.
ISO 10993-1, Biological evaluation of medical devices- Part 1: Evaluation and testing.
ISO 10993-9, Biological evaluation of medical devices- Part 9: Framework for identification and quantification of potential degradation products.
ISO 10993-12, Biological evaluation of medical devices- Part 12: Sample preparation and reference materials.
ISO 10993-13, Biological evaluation of medical devices- Part 13: ldentification and quantification of degradation products from polymeric medical devices.
ISO 10993-14,，Biological evaluation of medical devices- -Part 14: ldentification and quantification of degradation products from ceramics.
ISO 10993-16，Biological evaluation of medical devices- Part 16: Toxicokinetic study design for degradation products and leachables.