Official website

Doména gov.sk je oficálna

Toto je oficiálna webová stránka orgánu verejnej moci Slovenskej republiky. Oficiálne stránky využívajú najmä doménu gov.sk. Odkazy na jednotlivé webové sídla orgánov verejnej moci nájdete na tomto odkaze.

This page is secured

Buďte pozorní a vždy sa uistite, že zdieľate informácie iba cez zabezpečenú webovú stránku verejnej správy SR. Zabezpečená stránka vždy začína https:// pred názvom domény webového sídla.

  1. Home
  2. STN EN ISO 10993-18

STN EN ISO 10993-18

Back

Electronic version (pdc file)

Add to Cart
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)