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Standard Detayı
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TÜRK STANDARDI
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TS No :
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TS EN ISO 10993-15
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Kabul Tarihi :
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5.07.2023
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Hazırlık Grubu :
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Teknik Kurul |
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Doküman Tipi :
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Yürürlük Durumu :
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U (Yürürlükteki Standard/Standard) |
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Başlık :
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Tıbbî cihazların biyolojik değerlendirilmesi - Bölüm 15: Metaller ve alaşımlarından kaynaklanan bozunma ürünlerinin tanımlanması ve miktarının belirlenmesi |
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Başlık (İng) :
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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys |
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Kapsam :
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Kapsam (İng) :
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This document specifies general requirements for the design of tests for identifying and quantifying
degradation products from final metallic medical devices or corresponding material samples finished
as ready for clinical use.
This document is applicable only to those degradation products generated by chemical alteration of the
final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results
approximate the in vivo behaviour of the implant or material. The described chemical methodologies
are a means to generate degradation products for further assessments.
This document is applicable to both materials designed to degrade in the body as well as materials that
are not intended to degrade.
This document is not applicable to evaluation of degradation which occurs by purely mechanical
processes; methodologies for the production of this type of degradation product are described in
specific product standards, where available.
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the
scope of this document, such degradation products can evoke a biological response and can undergo biological
evaluation as described in other parts of ISO 10993.
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 w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific
requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable
clauses of ISO 10993-1 and ISO 10993-17). |
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Yerini Aldığı :
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TS EN ISO 10993-15 :2010; |
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Yararlanılan Kaynak :
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EN ISO 10993-15:2023 |
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Uluslararası Karşılıklar :
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EN ISO 10993-15-EQV; ISO 10993-15-EQV |
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ICS Kodu :
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11.100.20 Tıbbi cihazların biyolojik değerlendirmesi * Tıbbi mikrobiyoloji, bkz. 07.100.10 |
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Cen/Cenelec :
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CEN/ISO |
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Dili :
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en |
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Renk Durumu :
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Siyah-Beyaz |
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Uygulama Durumu :
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Yürürlükte |
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Sayfa Sayısı :
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31 |
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Fiyatı :
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72,00 EURO (2.496,22 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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