STN EN ISO 10993-18/Zmena A1
| 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) |