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Standard Detayı
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İptal Standard
TÜRK STANDARDI
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TS No :
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TS EN ISO 10993-4
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Kabul Tarihi :
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22.05.2017
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İptal Tarihi :
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19.03.2020 |
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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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H (İptal Edilmiş Standard/Withdrawn standard) |
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Başlık :
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Tıbbi cihazların biyolojik değerlendirilmesi - Bölüm 4: Kan ile etkileşim deneylerinin seçimi |
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Başlık (İng) :
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood |
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Kapsam :
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Kapsam (İng) :
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ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended. |
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Yerini Aldığı :
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TS EN ISO 10993-4 :2010; TS EN ISO 10993-4 :2010; |
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Yerine Geçen :
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TS EN ISO 10993-4 :2020; TS EN ISO 10993-4 :2020; |
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Yararlanılan Kaynak :
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EN ISO 10993-4:2017 |
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Uluslararası Karşılıklar :
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EN ISO 10993-4:2017-EQV; ISO 10993-4:2017-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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Yürürlükten kaldırıldı (Withdrawn Standard) |
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Sayfa Sayısı :
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86 |
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Fiyatı :
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115,00 EURO (4.020,64 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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