HRN EN ISO 10993-18:2020
Biološka procjena medicinskih proizvoda -- 18. dio: Kemijska svojstva medicinskih materijala unutar procesa upravljanja rizikom (ISO 10993-18:2020; EN ISO 10993-18:2020)
| Oznaka: | HRN EN ISO 10993-18:2020 |
| Naslov (HR): | Biološka procjena medicinskih proizvoda -- 18. dio: Kemijska svojstva medicinskih materijala unutar procesa upravljanja rizikom (ISO 10993-18:2020; EN ISO 10993-18:2020) |
| Naslov (EN): | Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020; EN ISO 10993-18:2020) |
| Područje primjene (EN): | 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. |
| Izdanje: | 3 |
| ICS: | 11.100.20 Biološko vrednovanje medicinskih proizvoda |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (rasprava): | HZN e-Glasilo 9/2018 () |
| Glasilo (objava): | HZN e-Glasilo 6/2020 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 60,00 € | Jezik: en | Cjenovni razred: M | Broj stranica: 77 |
| Izvornik: | EN ISO 10993-18:2020 |
| Zamjenjuje: | HRN EN ISO 10993-18:2010 |
| Direktiva/Uredba: | (EU) 2017/745 |
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