STN EN ISO 10993-18
| Name: | STN EN ISO 10993-18 |
| Validity: | Valid |
| Number of pages: | 85 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Biologické hodnotenie zdravotníckych pomôcok. Časť 18: Chemická charakterizácia materiálov zdravotníckych pomôcok v procese riadenia rizík (ISO 10993-18: 2020) |
| 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. 09. 2020 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-18:2020, idt ISO 10993-18:2020 |
| Official Journal | 08/20 |
| Amendments | Zmena A1 V 09/23 |
| Replaced by: | |
| Repleces: | STN EN ISO 10993-18:2009-08 (85 6510) |
| 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) |