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Standard Detayı
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Geri
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TÜRK STANDARDI
(Direktif :93/42/EEC,98/79/EC,90/385/EEC)
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TS No :
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TS EN ISO 13408-4
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Kabul Tarihi :
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22.11.2011
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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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Öneri aseptik şartlarda üretilen sağlık bakım ürünleri-Bölüm 4 yerinde temizleme şartları |
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Başlık (İng) :
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Aseptic processing of health care products - Part 4: Clean-in-place technologies |
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Kapsam :
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Kapsam (İng) :
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ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions. |
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Yerini Aldığı :
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TS EN 13824 :2005; |
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Yararlanılan Kaynak :
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EN ISO 13408-4:2011 |
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Uluslararası Karşılıklar :
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EN ISO 13408-4-EQV; ISO 13408-4-EQV |
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ICS Kodu :
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11.080.01 Sterilizasyon ve Dezenfeksiyon (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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Siyah-Beyaz |
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Uygulama Durumu :
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Yürürlükte |
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Sayfa Sayısı :
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28 |
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Fiyatı :
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68,00 EURO (2.357,54 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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