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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 10993-2
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Kabul Tarihi :
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12.10.2006
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İptal Tarihi :
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8.12.2022 |
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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H (İptal Edilmiş Standard/Withdrawn standard) |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 değerlendirmesi - Bölüm 2: Hayvansal sağlık özellikleri |
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Başlık (İng) :
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Biological evaluation of medical devices - Part 2: Animal welfare requirements |
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Kapsam :
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Kapsam (İng) :
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ISO 10993-2:2006 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. ISO 10993-2:2006 also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. |
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Yerini Aldığı :
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TS EN ISO 10993-2 :2001; |
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Yerine Geçen :
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TS EN ISO 10993-2 :2022; |
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Yararlanılan Kaynak :
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EN ISO 10993-2:2006 |
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ICS Kodu :
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11.060.01 Diş Hekimliği (Genel); 11.040.01 Tıbbi Ekipman (Genel); 11.120.01 Eczacılık (Genel); 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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24 |
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Fiyatı :
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64,00 EURO (2.237,57 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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