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855220 - ČSN EN ISO 10993-18 - Biologické hodnocení zdravotnických prostředků - Část 18: Chemická charakterizace materiálů zdravotnických prostředků v rámci procesu managementu rizik | ||
| Název : 855220 - ČSN EN ISO 10993-18 - Biologické hodnocení zdravotnických prostředků - Část 18: Chemická charakterizace materiálů zdravotnických prostředků v rámci procesu managementu rizik
Označení normy : ČSN EN ISO 10993-18 Katalogové číslo : 510928 Třídící znak : 855220 Účinnost : 2021-01-01 Věstník : 2020.12 Strany : 88 Převzata :vyhlášením ve Věstníku - v angličtině TATO NORMA JE NEPLATNÁ | ||
| Cena : | 594.00 Kč (DPH= 0%), s DPH= 594.00 Kč | Nelze zakoupit |
| ANOTACE "ČSN EN ISO 10993-18 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." | ||