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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 60601-2-16
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Kabul Tarihi :
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23.10.2015
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İptal Tarihi :
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30.09.2019 |
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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H (İptal Edilmiş Standard/Withdrawn standard) |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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Elektrikli tıbbî cihazlar - Bölüm 2-16: Hemodiyaliz, hemodiyafiltrasyon ve hemofiltrasyon cihazlarının temel güvenliği ve gerekli performansı için belirli özellikler |
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Başlık (İng) :
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Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment |
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Kapsam :
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Kapsam (İng) :
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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This International Standard does not take into consideration the DIALYSIS FLUID control system
of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID and CENTRAL DELIVERY
SYSTEMS. It does however take into consideration the specific safety requirements of such
HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.
This International Standard specifies the minimum safety requirements for HAEMODIALYSIS
EQUIPMENT. These devices are intended for use either by medical staff or for use by the
PATIENT or other trained personnel under the supervision of medical expertise.
This International Standard includes all ME EQUIPMENT that is intended to deliver a
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering
from kidney failure. |
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Yerini Aldığı :
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TS EN 60601-2-16 :1999; TS EN 60601-2-16 :2004; TS EN 60601-2-16/AC :2011; |
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Yerine Geçen :
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TS EN IEC 60601-2-16 :2019; |
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Yararlanılan Kaynak :
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EN 60601-2-16:2015 |
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Uluslararası Karşılıklar :
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EN 60601-2-16-EQV; IEC 60601-2-16-EQV |
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ICS Kodu :
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11.040.20 Transfüzyon, Infüzyon ve Enjeksiyon Ekipmanları
*Kan torbaları dahil; 11.040.25 Şırıngalar, iğneler ve kateterler |
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Cen/Cenelec :
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CENELEC/IEC |
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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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145 |
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Fiyatı :
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131,00 EURO (4.580,04 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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