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STN EN ISO 10993-18/Zmena A1

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Name: STN EN ISO 10993-18/Zmena A1
Validity: Valid
Number of pages: 16
Language:
EN
Paper: 14,10€
Electronic version a) Only read (without ability to print and copy) 12,69€
b) Without ability to print, with ability to copy (printscreen) 14,10€
c) With ability to print and copy (printscreen) 18,33€
Slovak title Biologické hodnotenie zdravotníckych pomôcok. Časť 18: Chemická charakterizácia materiálov zdravotníckych pomôcok v procese riadenia rizík. Zmena A1: Určenie faktora neistoty (ISO 10993-18: 2020/Amd 1: 2022)
English title Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Release Date: 01. 10. 2023
Date of withdrawal:
ICS: 11.100.20
Sorting character/National clasification code 85 6510
Level of incorporation: idt ISO 10993-18:2020/Amd 1:2022, idt EN ISO 10993-18:2020/A1:2023
Official Journal 09/23
Amendments
Replaced by:
Repleces:
Note in Official Journal:
Subject of the standard: 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);
Preview: Náhľad normy (PDF)