SIST EN ISO 10993-18:2020

Oznaka standarda: SIST EN ISO 10993-18:2020
Koda projekta: 00206074
Organizacija: SIST
Naslov (angleški): Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Naslov (slovenski): Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja tveganja (ISO 10993-18:2020)
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Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 10993-18:2020 angleški jezik Active SIST-M: 119.79 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.100.20
Status: Objavljen
Objavljen: 01-Nov-2020
Refer. št. objave: Sporocila 2020-11
Referenčna oznaka: EN ISO 10993-18:2020
Področje projekta (angleško): 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.
Povezava na standarde
Povezava Ime Datum
Dopolnjen z SIST EN ISO 10993-18:2020/oprA1:2021 - Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja tveganja - Dopolnilo 1: Določitev faktorja negotovosti (ISO 10993-18:2020/DAM 1:2021) 16-Jun-2021
Nadomešča SIST EN ISO 10993-18:2009 - Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov (ISO 10993-18:2005) 01-Nov-2020


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