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Standard Detayı
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TÜRK STANDARDI
(Direktif :90/385/EEC,93/42/EEC)
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TS No :
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TS EN 60601-1
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Kabul Tarihi :
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27.03.2007
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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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Elektrikli tıbbi donanım - Bölüm 1:Temel güvenlik ve gerekli performans için genel kurallar |
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Başlık (İng) :
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
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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
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this standard are not covered by specific requirements in this standard except in
7.2.13 and 8.4.1.
NOTE See also 4.2.
This standard can also be applied to equipment used for compensation or alleviation of
disease, injury or disability.
In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is
covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of
active implantable medical devices covered by ISO 14708-1 3). |
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Yerini Aldığı :
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TS 4535 EN 60601-1 :1998; TS EN 60601-1-4 :2003; TS EN 60601-1-1 :2010; TS EN 60601-1-1 :2001; |
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Tadil Eden :
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TS EN 60601-1/A12 :2015; TS EN 60601-1/AC :2011; TS EN 60601-1/A12 :2015; TS EN 60601-1/A1 :2014; TS EN 60601-1/A2 :2021; TS EN 60601-1/AC :2023; TS EN 60601-1/A1/AC :2014; TS EN 60601-1/A1/AC :2014; TS EN 60601-1/A13 :2024; |
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Yararlanılan Kaynak :
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EN 60601-1:2006 |
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Uluslararası Karşılıklar :
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EN 60601-1-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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CENELEC/IEC |
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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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406 |
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Fiyatı :
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210,00 EURO (7.664,37 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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