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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 20417
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Kabul Tarihi :
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6.05.2021
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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 cihazlar - Üretici tarafından sağlanacak bilgiler |
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Başlık (İng) :
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Medical devices - Information to be supplied by the manufacturer |
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Kapsam :
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Kapsam (İng) :
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NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical
device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally
applicable requirements for identification and labels on a medical device or accessory, the packaging,
marking of a medical device or accessory, and accompanying information. This document does not specify
the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and
documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over
requirements of this document. |
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Yerini Aldığı :
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TS EN 1041+A1 :2014; TS EN 1041+A1 :2014; |
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Yararlanılan Kaynak :
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EN ISO 20417:2021 |
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Uluslararası Karşılıklar :
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EN ISO 20417-EQV; ISO 20417-EQV |
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ICS Kodu :
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11.040.01 Tıbbi Ekipman (Genel) |
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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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Renkli |
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Uygulama Durumu :
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Yürürlükte |
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Sayfa Sayısı :
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86 |
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Fiyatı :
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115,00 EURO (3.987,02 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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