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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 10993-12
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Kabul Tarihi :
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30.09.2021
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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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Tıbbi cihazların biyolojik değerlendirilmesi -
Bölüm 12: Numune hazırlanması ve referans malzemeler |
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Başlık (İng) :
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Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials |
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Kapsam :
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Kapsam (İng) :
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This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
— test sample selection;
— selection of representative portions from a medical device;
— test sample preparation;
— experimental controls;
— selection of, and requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant. |
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Yerini Aldığı :
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TS EN ISO 10993-12 :2013; TS EN ISO 10993-12 :2013; |
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Yararlanılan Kaynak :
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EN ISO 10993-12:2021 |
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Uluslararası Karşılıklar :
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EN ISO 10993-12-EQV; ISO 10993-12-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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37 |
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Fiyatı :
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80,00 EURO (2.919,76 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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