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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 11607-1
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Kabul Tarihi :
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18.12.2017
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İptal Tarihi :
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9.11.2020 |
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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H (İptal Edilmiş Standard/Withdrawn standard) |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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Nihai olarak steril edilmiş tıbbi cihazlar için ambalajlama - Bölüm 1: Malzemeler, steril bariyer sistemleri ve ambalajlama sistemleri için kurallar |
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Başlık (İng) :
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
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Kapsam :
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- |
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Kapsam (İng) :
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ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture. |
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Yerini Aldığı :
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TS EN ISO 11607-1 :2010; TS EN ISO 11607-1 :2010; TS EN ISO 11607-1/A1 :2014; TS EN ISO 11607-1/A1 :2014; |
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Yerine Geçen :
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TS EN ISO 11607-1 :2020; |
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Yararlanılan Kaynak :
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EN ISO 11607-1:2017 |
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Uluslararası Karşılıklar :
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EN ISO 11607-1-EQV; ISO 11607-1:2006, including Amd-EQV |
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ICS Kodu :
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11.080.30 Steril Ambalajlama |
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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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29 |
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Fiyatı :
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68,00 EURO (2.377,42 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
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