Skip to main content
Tagasi

ISO 10993-18:2020

Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process

Üldinfo

Kehtiv alates 13.01.2020
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
11.05.2022
Muudatus
13.01.2020
Põhitekst
30.06.2005
Põhitekst
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.

Nõutud väljad on tähistatud *

*
*
*
PDF
254,36 € koos KM-ga
Paber
254,36 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst

ISO/TS 10993-19:2020

Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
Uusim versioon Kehtiv alates 12.03.2020
Põhitekst

ISO 10993-15:2019

Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
Uusim versioon Kehtiv alates 26.11.2019
Põhitekst

ISO 10993-9:2019

Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
Uusim versioon Kehtiv alates 26.11.2019
Muudatus

EVS-EN ISO 11135:2014/A1:2019

Tervishoiutoodete steriliseerimine. Etüleenoksiid. Nõuded meditsiiniseadmete steriliseerimisprotsessi väljatöötamiseks, valideerimiseks ja rutiinseks kontrollimiseks. Muudatus 1: Lisa E redaktsioon, üksikpartii vabasse ringlusse laskmine
Uusim versioon Kehtiv alates 02.12.2019