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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 10993-18
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Kabul 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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U (Yürürlükteki Standard/Standard) |
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Başlık :
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Tıbbi cihazların biyolojik değerlendirilmesi - Bölüm 18: Tıbbi cihaz malzemelerinin kimyasal özelliklerinin bir risk yönetim süreci içinde belirlenmesi |
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Başlık (İng) :
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Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process |
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Kapsam :
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Kapsam (İng) :
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This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following: — the identification of its materials of construction (medical device configuration); — the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); — the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); — the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); — the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables). This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact). This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation. |
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Yerini Aldığı :
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TS EN ISO 10993-18 :2010; TS EN ISO 10993-18 :2010; |
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Tadil Eden :
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TS EN ISO 10993-18/A1 :2023; |
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Yararlanılan Kaynak :
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EN ISO 10993-18:2020 |
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Uluslararası Karşılıklar :
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EN ISO 10993-18-EQV; ISO 10993-18-EQV |
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ICS Kodu :
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11.100.20 Tıbbi cihazların biyolojik değerlendirmesi * Tıbbi mikrobiyoloji, bkz. 07.100.10 |
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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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87 |
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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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